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1. Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes

Author

Kosiborod, M, Petrie, M, Borlaug, B, Butler, J, Davies, M, Hovingh, G, Kitzman, D, Moller, D, Treppendahl, M, Verma, S, Jensen, T, Liisberg, K, Lindegaard, M, Abhayaratna, W, Ahmed, F, Ben-Gal, T, Chopra, V, Ezekowitz, J, Fu, M, Ito, H, Lelonek, M, Melenovsky, V, Merkely, B, Nunez, J, Perna, E, Schou, M, Senni, M, Sharma, K, van der Meer, P, Von Lewinski, D, Wolf, D, Shah, S, Kosiborod M. N., Petrie M. C., Borlaug B. A., Butler J., Davies M. J., Hovingh G. K., Kitzman D. W., Moller D. V., Treppendahl M. B., Verma S., Jensen T. J., Liisberg K., Lindegaard M. L., Abhayaratna W., Ahmed F. Z., Ben-Gal T., Chopra V., Ezekowitz J. A., Fu M., Ito H., Lelonek M., Melenovsky V., Merkely B., Nunez J., Perna E., Schou M., Senni M., Sharma K., van der Meer P., Von Lewinski D., Wolf D., Shah S. J., Kosiborod, M, Petrie, M, Borlaug, B, Butler, J, Davies, M, Hovingh, G, Kitzman, D, Moller, D, Treppendahl, M, Verma, S, Jensen, T, Liisberg, K, Lindegaard, M, Abhayaratna, W, Ahmed, F, Ben-Gal, T, Chopra, V, Ezekowitz, J, Fu, M, Ito, H, Lelonek, M, Melenovsky, V, Merkely, B, Nunez, J, Perna, E, Schou, M, Senni, M, Sharma, K, van der Meer, P, Von Lewinski, D, Wolf, D, Shah, S, Kosiborod M. N., Petrie M. C., Borlaug B. A., Butler J., Davies M. J., Hovingh G. K., Kitzman D. W., Moller D. V., Treppendahl M. B., Verma S., Jensen T. J., Liisberg K., Lindegaard M. L., Abhayaratna W., Ahmed F. Z., Ben-Gal T., Chopra V., Ezekowitz J. A., Fu M., Ito H., Lelonek M., Melenovsky V., Merkely B., Nunez J., Perna E., Schou M., Senni M., Sharma K., van der Meer P., Von Lewinski D., Wolf D., and Shah S. J.

Abstract

BACKGROUND Obesity and type 2 diabetes are prevalent in patients with heart failure with preserved ejection fraction and are characterized by a high symptom burden. No approved therapies specifically target obesity-related heart failure with preserved ejection fraction in persons with type 2 diabetes. METHODS We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. The primary end points were the change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS; scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations) and the change in body weight. Confirmatory secondary end points included the change in 6-minute walk distance; a hierarchical composite end point that included death, heart failure events, and differences in the change in the KCCQ-CSS and 6-minute walk distance; and the change in the C-reactive protein (CRP) level. RESULTS A total of 616 participants underwent randomization. The mean change in the KCCQ-CSS was 13.7 points with semaglutide and 6.4 points with placebo (estimated difference, 7.3 points; 95% confidence interval [CI], 4.1 to 10.4; P<0.001), and the mean percentage change in body weight was −9.8% with semaglutide and −3.4% with placebo (estimated difference, −6.4 percentage points; 95% CI, −7.6 to −5.2; P<0.001). The results for the confirmatory secondary end points favored semaglutide over placebo (estimated between-group difference in change in 6-min-ute walk distance, 14.3 m [95% CI, 3.7 to 24.9; P=0.008]; win ratio for hierarchical composite end point, 1.58 [95% CI, 1.29 to 1.94; P<0.001]; and estimated treatment ratio for change in CRP level, 0.67 [95% CI, 0.55 to 0.80; P<0.001]). Serious adverse events were reported in 55 parti

Published
2024

2. Inflammation in Obesity-Related HFpEF: The STEP-HFpEF Program

Author

Verma, S, Petrie, M, Borlaug, B, Butler, J, Davies, M, Kitzman, D, Shah, S, Ronnback, C, Abildstrom, S, Liisberg, K, Wolf, D, von Lewinski, D, Lelonek, M, Melenovsky, V, Senni, M, Kosiborod, M, Verma S., Petrie M. C., Borlaug B. A., Butler J., Davies M. J., Kitzman D. W., Shah S. J., Ronnback C., Abildstrom S. Z., Liisberg K., Wolf D., von Lewinski D., Lelonek M., Melenovsky V., Senni M., Kosiborod M. N., Verma, S, Petrie, M, Borlaug, B, Butler, J, Davies, M, Kitzman, D, Shah, S, Ronnback, C, Abildstrom, S, Liisberg, K, Wolf, D, von Lewinski, D, Lelonek, M, Melenovsky, V, Senni, M, Kosiborod, M, Verma S., Petrie M. C., Borlaug B. A., Butler J., Davies M. J., Kitzman D. W., Shah S. J., Ronnback C., Abildstrom S. Z., Liisberg K., Wolf D., von Lewinski D., Lelonek M., Melenovsky V., Senni M., and Kosiborod M. N.

Abstract

Background: Inflammation is thought to be an important mechanism for the development and progression of obesity-related heart failure with preserved ejection fraction (HFpEF). In the STEP-HFpEF Program, once-weekly 2.4 mg semaglutide improved heart failure–related symptoms, physical limitations, and exercise function, reduced the levels of C-reactive protein (CRP), a biomarker of inflammation, and reduced body weight in participants with obesity-related HFpEF. However, neither the prevalence nor the clinical characteristics of patients who have various magnitudes of inflammation in the context of obesity-related HFpEF have been well described. Furthermore, whether the beneficial effects of semaglutide on the various HF efficacy endpoints in the STEP-HFpEF Program are modified by the baseline levels of inflammation has not been fully established. Finally, the relationship between weight reduction and changes in CRP across the STEP-HFpEF Program have not been fully defined. Objectives: This study sought to: 1) evaluate baseline characteristics and clinical features of patients with obesity-related HFpEF that have various levels of inflammation in the STEP-HFpEF Program; 2) determine if the effects of weekly semaglutide 2.4 mg vs placebo across all key outcomes are influenced by baseline levels of inflammation assessed by CRP levels; and 3) determine the relationship between change in CRP and weight loss in the STEP-HFpEF Program. Methods: This was a secondary analysis of pooled data from 2 international, double-blind, placebo-controlled, randomized trials (STEP-HFpEF and STEP-HFpEF DM). The outcomes were change in the dual primary endpoints (health status [measured by the Kansas City Cardiomyopathy Questionnaire—Clinical Summary Score (KCCQ-CSS)] and body weight) from baseline to 52 weeks according to baseline CRP levels. Additional efficacy endpoints included change in 6-minute walk distance (6MWD), a hierarchical composite endpoint that included death, heart failure

Published
2024

3. Effect of Semaglutide on Cardiac Structure and Function in Patients With Obesity-Related Heart Failure

Author

Solomon, S, Ostrominski, J, Wang, X, Shah, S, Borlaug, B, Butler, J, Davies, M, Kitzman, D, Verma, S, Abildstrom, S, Nygaard Einfeldt, M, Rasmussen, S, Abhayaratna, W, Ahmed, F, Ben-Gal, T, Chopra, V, Ito, H, Merkely, B, Nunez, J, Senni, M, van der Meer, P, Wolf, D, Petrie, M, Kosiborod, M, Solomon S. D., Ostrominski J. W., Wang X., Shah S. J., Borlaug B. A., Butler J., Davies M. J., Kitzman D. W., Verma S., Abildstrom S. Z., Nygaard Einfeldt M., Rasmussen S., Abhayaratna W. P., Ahmed F. Z., Ben-Gal T., Chopra V., Ito H., Merkely B., Nunez J., Senni M., van der Meer P., Wolf D., Petrie M. C., Kosiborod M. N., Solomon, S, Ostrominski, J, Wang, X, Shah, S, Borlaug, B, Butler, J, Davies, M, Kitzman, D, Verma, S, Abildstrom, S, Nygaard Einfeldt, M, Rasmussen, S, Abhayaratna, W, Ahmed, F, Ben-Gal, T, Chopra, V, Ito, H, Merkely, B, Nunez, J, Senni, M, van der Meer, P, Wolf, D, Petrie, M, Kosiborod, M, Solomon S. D., Ostrominski J. W., Wang X., Shah S. J., Borlaug B. A., Butler J., Davies M. J., Kitzman D. W., Verma S., Abildstrom S. Z., Nygaard Einfeldt M., Rasmussen S., Abhayaratna W. P., Ahmed F. Z., Ben-Gal T., Chopra V., Ito H., Merkely B., Nunez J., Senni M., van der Meer P., Wolf D., Petrie M. C., and Kosiborod M. N.

Abstract

Background: Obesity is associated with adverse cardiac remodeling and is a key driver for the development and progression of heart failure (HF). Once-weekly semaglutide (2.4 mg) has been shown to improve HF-related symptoms and physical limitations, body weight, and exercise function in patients with obesity-related heart failure with preserved ejection fraction (HFpEF), but the effects of semaglutide on cardiac structure and function in this population remain unknown. Objectives: In this echocardiography substudy of the STEP-HFpEF Program, we evaluated treatment effects of once-weekly semaglutide (2.4 mg) vs placebo on cardiac structure and function. Methods: Echocardiography at randomization and 52 weeks was performed in 491 of 1,145 participants (43%) in the STEP-HFpEF Program (pooled STEP-HFpEF [Semaglutide Treatment Effect in People with Obesity and HFpEF] and STEP-HFpEF DM [Semaglutide Treatment Effect in People with Obesity, HFpEF, and Type 2 Diabetes] trials). The prespecified primary outcome was change in left atrial (LA) volume, with changes in other echocardiography parameters evaluated as secondary outcomes. Treatment effects of semaglutide vs placebo were assessed using analysis of covariance stratified by trial and body mass index, with adjustment for baseline parameter values. Results: Overall, baseline clinical and echocardiographic characteristics were balanced among those receiving semaglutide (n = 253) and placebo (n = 238). Between baseline and 52 weeks, semaglutide attenuated progression of LA remodeling (estimated mean difference [EMD] in LA volume, −6.13 mL; 95% CI: −9.85 to −2.41 mL; P = 0.0013) and right ventricular (RV) enlargement (EMD in RV end-diastolic area: −1.99 cm2; 95% CI: −3.60 to −0.38 cm2; P = 0.016; EMD in RV end-systolic area: −1.41 cm2; 95% CI: −2.42 to −0.40] cm2; P = 0.0064) compared with placebo. Semaglutide additionally improved E-wave velocity (EMD: −5.63 cm/s; 95% CI: −9.42 to −1.84 cm/s; P = 0.0037), E/A (early/late mit

Published
2024

4. Effect of Dapagliflozin on Accelerometer-Based Measures of Physical Activity in Patients With Heart Failure: An Analysis of the DETERMINE Trials

Author

Docherty, K, Lopez, R, Folkvaljon, F, de Boer, R, Cowie, M, Hammarstedt, A, Kitzman, D, Kosiborod, M, Langkilde, A, Reicher, B, Senni, M, Shah, S, Verma, S, Solomon, S, Mcmurray, J, Docherty K. F., Lopez R. B., Folkvaljon F., de Boer R. A., Cowie M. R., Hammarstedt A., Kitzman D. W., Kosiborod M. N., Langkilde A. M., Reicher B., Senni M., Shah S. J., Verma S., Solomon S. D., McMurray J. J. V., Docherty, K, Lopez, R, Folkvaljon, F, de Boer, R, Cowie, M, Hammarstedt, A, Kitzman, D, Kosiborod, M, Langkilde, A, Reicher, B, Senni, M, Shah, S, Verma, S, Solomon, S, Mcmurray, J, Docherty K. F., Lopez R. B., Folkvaljon F., de Boer R. A., Cowie M. R., Hammarstedt A., Kitzman D. W., Kosiborod M. N., Langkilde A. M., Reicher B., Senni M., Shah S. J., Verma S., Solomon S. D., and McMurray J. J. V.

Abstract

BACKGROUND: Wearable accelerometers can quantify the frequency and intensity of physical activity during everyday life and may provide complementary data to established functional outcome measures on the effect of heart failure therapies on functional limitations. METHODS: In a voluntary substudy of the DETERMINE trials (Dapagliflozin Effect on Exercise Capacity Using a 6-Minute Walk Test in Patients With Heart Failure), patients wore a waist-worn triaxial accelerometer for as long as possible (ideally for 24 h/d for 7 days) at 3 points during the trial, between the screening visit and randomization (baseline data), and during weeks 8 and 14 to 16. Accelerometer outcomes included the change from baseline to week 16 in the total number of steps, time spent in light-to-vigorous physical activity, time spent in moderate-to-vigorous physical activity, movement intensity during walking, number of vector magnitude units‚ and total activity counts. RESULTS: Adequate baseline and week 16 accelerometer data were available for 211 of 817 (26%) randomized patients (defined as ≥10 hours of wear time for ≥3 days). Dapagliflozin had a favorable effect on the mean change from baseline at 16 weeks in the number of steps (between-group difference, 778 [95% CI, 240–1315]), time spent in moderate-to-vigorous physical activity (0.16 [95% CI, 0.03–0.29] hours), and in the mean vector magnitude units (25 [95% CI, 0.1–49] counts per minute). There were no between-group differences in the other accelerometer outcomes of interest. CONCLUSIONS: In this exploratory analysis of the DETERMINE trials, dapagliflozin had a beneficial effect on selected accelerometer-based measures of physical activity in patients with heart failure across the entire left ventricular ejection fraction spectrum, yet did not improve 6-minute walk distance, as previously reported. These data suggest that accelerometer-based measurements of everyday activity may provide complementary information to 6-minute walk distan

Published
2024

5. Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials

Author

Butler, J, Shah, S, Petrie, M, Borlaug, B, Abildstrom, S, Davies, M, Hovingh, G, Kitzman, D, Moller, D, Verma, S, Einfeldt, M, Lindegaard, M, Rasmussen, S, Abhayaratna, W, Ahmed, F, Ben-Gal, T, Chopra, V, Ezekowitz, J, Fu, M, Ito, H, Lelonek, M, Melenovsky, V, Merkely, B, Nunez, J, Perna, E, Schou, M, Senni, M, Sharma, K, van der Meer, P, Von Lewinski, D, Wolf, D, Kosiborod, M, Butler J., Shah S. J., Petrie M. C., Borlaug B. A., Abildstrom S. Z., Davies M. J., Hovingh G. K., Kitzman D. W., Moller D. V., Verma S., Einfeldt M. N., Lindegaard M. L., Rasmussen S., Abhayaratna W., Ahmed F. Z., Ben-Gal T., Chopra V., Ezekowitz J. A., Fu M., Ito H., Lelonek M., Melenovsky V., Merkely B., Nunez J., Perna E., Schou M., Senni M., Sharma K., van der Meer P., Von Lewinski D., Wolf D., Kosiborod M. N., Butler, J, Shah, S, Petrie, M, Borlaug, B, Abildstrom, S, Davies, M, Hovingh, G, Kitzman, D, Moller, D, Verma, S, Einfeldt, M, Lindegaard, M, Rasmussen, S, Abhayaratna, W, Ahmed, F, Ben-Gal, T, Chopra, V, Ezekowitz, J, Fu, M, Ito, H, Lelonek, M, Melenovsky, V, Merkely, B, Nunez, J, Perna, E, Schou, M, Senni, M, Sharma, K, van der Meer, P, Von Lewinski, D, Wolf, D, Kosiborod, M, Butler J., Shah S. J., Petrie M. C., Borlaug B. A., Abildstrom S. Z., Davies M. J., Hovingh G. K., Kitzman D. W., Moller D. V., Verma S., Einfeldt M. N., Lindegaard M. L., Rasmussen S., Abhayaratna W., Ahmed F. Z., Ben-Gal T., Chopra V., Ezekowitz J. A., Fu M., Ito H., Lelonek M., Melenovsky V., Merkely B., Nunez J., Perna E., Schou M., Senni M., Sharma K., van der Meer P., Von Lewinski D., Wolf D., and Kosiborod M. N.

Abstract

Background: In the STEP-HFpEF (NCT04788511) and STEP-HFpEF DM (NCT04916470) trials, the GLP-1 receptor agonist semaglutide improved symptoms, physical limitations, bodyweight, and exercise function in people with obesity-related heart failure with preserved ejection fraction. In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, we aimed to provide a more definitive assessment of the effects of semaglutide across a range of outcomes and to test whether these effects were consistent across key patient subgroups. Methods: We conducted a prespecified pooled analysis of individual patient data from STEP-HFpEF and STEP-HFpEF DM, randomised, double-blind, placebo-controlled trials at 129 clinical research sites in 18 countries. In both trials, eligible participants were aged 18 years or older, had heart failure with a left ventricular ejection fraction of at least 45%, a BMI of at least 30 kg/m2, New York Heart Association class II–IV symptoms, and a Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS; a measure of heart failure-related symptoms and physical limitations) of less than 90 points. In STEP-HFpEF, people with diabetes or glycated haemoglobin A1c concentrations of at least 6·5% were excluded, whereas for inclusion in STEP-HFpEF DM participants had to have been diagnosed with type 2 diabetes at least 90 days before screening and to have an HbA1c of 10% or lower. In both trials, participants were randomly assigned to either 2·4 mg semaglutide once weekly or matched placebo for 52 weeks. The dual primary endpoints were change from baseline to week 52 in KCCQ-CSS and bodyweight in all randomly assigned participants. Confirmatory secondary endpoints included change from baseline to week 52 in 6-min walk distance, a hierarchical composite endpoint (all-cause death, heart failure events, and differences in changes in KCCQ-CSS and 6-min walk distance); and C-reactive protein (CRP) concentrations. Heterogeneity in treatme

Published
2024

6. Effect of Dapagliflozin Versus Placebo on Symptoms and 6-Minute Walk Distance in Patients With Heart Failure: The DETERMINE Randomized Clinical Trials

Author

Mcmurray, J, Docherty, K, de Boer, R, Hammarstedt, A, Kitzman, D, Kosiborod, M, Langkilde, A, Reicher, B, Senni, M, Shah, S, Wilderang, U, Verma, S, Solomon, S, McMurray J. J. V., Docherty K. F., de Boer R. A., Hammarstedt A., Kitzman D. W., Kosiborod M. N., Langkilde A. M., Reicher B., Senni M., Shah S. J., Wilderang U., Verma S., Solomon S. D., Mcmurray, J, Docherty, K, de Boer, R, Hammarstedt, A, Kitzman, D, Kosiborod, M, Langkilde, A, Reicher, B, Senni, M, Shah, S, Wilderang, U, Verma, S, Solomon, S, McMurray J. J. V., Docherty K. F., de Boer R. A., Hammarstedt A., Kitzman D. W., Kosiborod M. N., Langkilde A. M., Reicher B., Senni M., Shah S. J., Wilderang U., Verma S., and Solomon S. D.

Abstract

BACKGROUND: Sodium-glucose cotransporter 2 inhibitors reduce the risk of worsening heart failure (HF) and cardiovascular death in patients with HF irrespective of left ventricular ejection fraction. It is important to determine whether therapies for HF improve symptoms and functional capacity. METHODS: The DETERMINE (Dapagliflozin Effect on Exercise Capacity Using a 6-Minute Walk Test in Patients With Heart Failure) double-blind, placebo-controlled, multicenter trials assessed the efficacy of the sodium-glucose cotransporter 2 inhibitor dapagliflozin on the Total Symptom Score (TSS) and Physical Limitation Scale (PLS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ) and 6-minute walk distance (6MWD) in 313 patients with HF with reduced ejection fraction (DETERMINE-Reduced) and in 504 patients with HF with preserved ejection fraction (DETERMINE-Preserved) with New York Heart Association class II or III symptoms and elevated natriuretic peptide levels. The primary outcomes were changes in the KCCQ-TSS, KCCQ-PLS, and 6MWD after 16 weeks of treatment. RESULTS: Among the 313 randomized patients with HF with reduced ejection fraction, the median placebo-corrected difference in KCCQ-TSS from baseline at 16 weeks was 4.2 (95% CI, 1.0, 8.2; P=0.022) in favor of dapagliflozin. The median placebo-corrected difference in KCCQ-PLS was 4.2 (95% CI, 0.0, 8.3; P=0.058). The median placebo-corrected difference in 6MWD from baseline at 16 weeks was 3.2 meters (95% CI, −6.5, 13.0; P=0.69). In the 504 patients with HF with preserved ejection fraction, the median placebo-corrected 16-week difference in KCCQ-TSS and KCCQ-PLS was 3.2 (95% CI, 0.4, 6.0; P=0.079) and 3.1 (−0.1, 5.4; P=0.23), respectively. The median 16-week difference in 6MWD was 1.6 meters (95% CI, −5.9, 9.0; P=0.67). In an exploratory post hoc analysis of both trials combined (DETERMINE-Pooled), the median placebo-corrected difference from baseline at 16 weeks was 3.7 (1.5, 5.9; P=0.005) for KCCQ-TSS, 4.0 (0.3, 4.9

Published
2024

7. Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity

Author

Kosiborod, M, Abildstrom, S, Borlaug, B, Butler, J, Rasmussen, S, Davies, M, Hovingh, G, Kitzman, D, Lindegaard, M, Moller, D, Shah, S, Treppendahl, M, Verma, S, Abhayaratna, W, Ahmed, F, Chopra, V, Ezekowitz, J, Fu, M, Ito, H, Lelonek, M, Melenovsky, V, Merkely, B, Nunez, J, Perna, E, Schou, M, Senni, M, Sharma, K, Van Der Meer, P, Von Lewinski, D, Wolf, D, Petrie, M, Kosiborod M. N., Abildstrom S. Z., Borlaug B. A., Butler J., Rasmussen S., Davies M., Hovingh G. K., Kitzman D. W., Lindegaard M. L., Moller D. V., Shah S. J., Treppendahl M. B., Verma S., Abhayaratna W., Ahmed F. Z., Chopra V., Ezekowitz J., Fu M., Ito H., Lelonek M., Melenovsky V., Merkely B., Nunez J., Perna E., Schou M., Senni M., Sharma K., Van Der Meer P., Von Lewinski D., Wolf D., Petrie M. C., Kosiborod, M, Abildstrom, S, Borlaug, B, Butler, J, Rasmussen, S, Davies, M, Hovingh, G, Kitzman, D, Lindegaard, M, Moller, D, Shah, S, Treppendahl, M, Verma, S, Abhayaratna, W, Ahmed, F, Chopra, V, Ezekowitz, J, Fu, M, Ito, H, Lelonek, M, Melenovsky, V, Merkely, B, Nunez, J, Perna, E, Schou, M, Senni, M, Sharma, K, Van Der Meer, P, Von Lewinski, D, Wolf, D, Petrie, M, Kosiborod M. N., Abildstrom S. Z., Borlaug B. A., Butler J., Rasmussen S., Davies M., Hovingh G. K., Kitzman D. W., Lindegaard M. L., Moller D. V., Shah S. J., Treppendahl M. B., Verma S., Abhayaratna W., Ahmed F. Z., Chopra V., Ezekowitz J., Fu M., Ito H., Lelonek M., Melenovsky V., Merkely B., Nunez J., Perna E., Schou M., Senni M., Sharma K., Van Der Meer P., Von Lewinski D., Wolf D., and Petrie M. C.

Abstract

Background Heart failure with preserved ejection fraction is increasing in prevalence and is associated with a high symptom burden and functional impairment, especially in persons with obesity. No therapies have been approved to target obesity-related heart failure with preserved ejection fraction. Methods We randomly assigned 529 patients who had heart failure with preserved ejection fraction and a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or higher to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. The dual primary end points were the change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS; scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations) and the change in body weight. Confirmatory secondary end points included the change in the 6-minute walk distance; a hierarchical composite end point that included death, heart failure events, and differences in the change in the KCCQ-CSS and 6-minute walk distance; and the change in the C-reactive protein (CRP) level. Results The mean change in the KCCQ-CSS was 16.6 points with semaglutide and 8.7 points with placebo (estimated difference, 7.8 points; 95% confidence interval [CI], 4.8 to 10.9; P<0.001), and the mean percentage change in body weight was -13.3% with semaglutide and -2.6% with placebo (estimated difference, -10.7 percentage points; 95% CI, -11.9 to -9.4; P<0.001). The mean change in the 6-minute walk distance was 21.5 m with semaglutide and 1.2 m with placebo (estimated difference, 20.3 m; 95% CI, 8.6 to 32.1; P<0.001). In the analysis of the hierarchical composite end point, semaglutide produced more wins than placebo (win ratio, 1.72; 95% CI, 1.37 to 2.15; P<0.001). The mean percentage change in the CRP level was -43.5% with semaglutide and -7.3% with placebo (estimated treatment ratio, 0.61; 95% CI, 0.51 to 0.72; P<0.001). Serious ad

Published
2023

8. Semaglutide in Patients With Obesity and Heart Failure Across Mildly Reduced or Preserved Ejection Fraction

Author

Butler, J, Abildstrom, S, Borlaug, B, Davies, M, Kitzman, D, Petrie, M, Shah, S, Verma, S, Abhayaratna, W, Chopra, V, Ezekowitz, J, Fu, M, Ito, H, Lelonek, M, Nunez, J, Perna, E, Schou, M, Senni, M, van der Meer, P, von Lewinski, D, Wolf, D, Altschul, R, Rasmussen, S, Kosiborod, M, Butler J., Abildstrom S. Z., Borlaug B. A., Davies M. J., Kitzman D. W., Petrie M. C., Shah S. J., Verma S., Abhayaratna W. P., Chopra V., Ezekowitz J. A., Fu M., Ito H., Lelonek M., Nunez J., Perna E., Schou M., Senni M., van der Meer P., von Lewinski D., Wolf D., Altschul R. L., Rasmussen S., Kosiborod M. N., Butler, J, Abildstrom, S, Borlaug, B, Davies, M, Kitzman, D, Petrie, M, Shah, S, Verma, S, Abhayaratna, W, Chopra, V, Ezekowitz, J, Fu, M, Ito, H, Lelonek, M, Nunez, J, Perna, E, Schou, M, Senni, M, van der Meer, P, von Lewinski, D, Wolf, D, Altschul, R, Rasmussen, S, Kosiborod, M, Butler J., Abildstrom S. Z., Borlaug B. A., Davies M. J., Kitzman D. W., Petrie M. C., Shah S. J., Verma S., Abhayaratna W. P., Chopra V., Ezekowitz J. A., Fu M., Ito H., Lelonek M., Nunez J., Perna E., Schou M., Senni M., van der Meer P., von Lewinski D., Wolf D., Altschul R. L., Rasmussen S., and Kosiborod M. N.

Abstract

Background: Many therapies for heart failure (HF) have shown differential impact across the spectrum of left ventricular ejection fraction (LVEF). Objectives: In this prespecified analysis, the authors assessed the effects of semaglutide across the baseline LVEF strata in patients with the obesity phenotype of HF with preserved ejection fraction (HFpEF) in the STEP-HFpEF (Semaglutide Treatment Effect in People with obesity and HFpEF) trial. Methods: STEP-HFpEF randomized 529 patients (263 semaglutide; 266 placebo). For this prespecified analysis, patients were categorized into 3 groups based on LVEF: 45% to 49% (n = 85), 50% to 59% (n = 215), and ≥60% (n = 229). Results: At 52 weeks, semaglutide improved the dual primary endpoints of Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (estimated treatment difference: EF [ejection fraction] 45%-49%: 5.0 points [95% CI: −2.7 to 12.8 points], EF 50%-59%: 9.8 points [95% CI: 5.0 to 14.6 points], and EF ≥60%: 7.4 points [95% CI: 2.8 to 12.0 points]; P interaction = 0.56) and body weight (EF: 45%-49%: −7.6 [95% CI: −10.7 to −4.4], EF 50%-59%: −10.6 [95% CI: −12.6 to −8.6] and EF ≥60%: −11.9 [95% CI: −13.8 to −9.9]; P interaction = 0.08), to a similar extent across LVEF categories. Likewise, LVEF did not influence the benefit of semaglutide on confirmatory secondary endpoints: 6-minute walk distance (P interaction = 0.19), hierarchal composite endpoint (P interaction = 0.43), and high-sensitivity C-reactive protein (P interaction = 0.26); or exploratory endpoint of N-terminal pro-brain natriuretic peptide (P interaction = 0.96). Semaglutide was well-tolerated across LVEF categories. Conclusions: In patients with HFpEF and obesity, semaglutide 2.4 mg improved symptoms, physical limitations, and exercise function, and reduced inflammation and body weight to a similar extent across LVEF categories. These data support treatment with semaglutide in patients with the obesity phenotype of HFpEF regardless of LVEF. (Re

Published
2023

31. Left ventricular diastolic filling response to stationary bicycle exercise during pregnancy and the postpartum period.

Author

Veille, Jean-Claude, Kitzman, Dalane W., Millsaps, Piper D., Kilgo, Patrick D., Veille, J C, Kitzman, D W, Millsaps, P D, and Kilgo, P D

Subjects
PREGNANCY, EXERCISE, DIASTOLE (Cardiac cycle), HEART physiology, LEFT heart ventricle, ANALYSIS of variance, CARDIAC output, CLINICAL trials, COMPARATIVE studies, DOPPLER echocardiography, EXERCISE tests, HEART function tests, RESEARCH methodology, MEDICAL cooperation, THIRD trimester of pregnancy, PROBABILITY theory, PUERPERIUM, REFERENCE values, RESEARCH, RESEARCH funding, HEALTH self-care, SELF-evaluation, EVALUATION research, RANDOMIZED controlled trials
Abstract

Objective: The purpose of this study was to determine the effects of pregnancy and of maximal exercise on left ventricular diastolic filling response.Study Design: Transmitral pulsed Doppler echocardiography was obtained in 10 healthy women during each trimester of pregnancy and at 12 weeks after delivery. Doppler studies were performed at rest and at each exercise workload. The P-R interval, the early and atrial peak flow velocities, the mitral early deceleration time, and the isovolumetric relaxation time were analyzed. Data are expressed as the mean and standard deviation of the mean. Values obtained during the last trimester of pregnancy were used as the pregnant value; values at the 12 weeks after delivery were used as the nonpregnant value. Paired t -test, analysis of variance, and mixed models were used to determine significance with a probability value of <.05.Results: Pregnancy significantly increased the early and atrial peak flow velocities. Pregnancy decreased the P-R interval, the early deceleration time, and the isovolumetric relaxation time. Exercise significantly decreased these diastolic functions; but pregnancy, in any of the 3 trimesters, did not significantly affect this response.Conclusion: Pregnancy increased left ventricular diastolic camber stiffness at rest and shifted left ventricular diastolic filling during exercise from predominantly early to atrial filling. This finding suggests that there is an increase in left ventricular chamber stiffness during maximal upright bicycle exercise in pregnancy. [ABSTRACT FROM AUTHOR]

Published
2001
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32. Relationship between left ventricular diastolic relaxation and systolic function in hypertension: The Hypertension Genetic Epidemiology Network (HyperGEN) Study.

Author

Bella, Jonathan N., Palmieri, Vittorio, Liu, Jennifer E., Kitzman, Dalane W., Oberman, Albert, Hunt, Steven C., Hopkins, Paul N., Rao, D.C., Arnett, Donna K., Devereux, Richard B., Bella, J N, Palmieri, V, Liu, J E, Kitzman, D W, Oberman, A, Hunt, S C, Hopkins, P N, Arnett, D K, Devereux, R B, and Hypertension Genetic Epidemiology Network Study Group

Published
2001

35. Diastolic dysfunction as a cause of exercise intolerance.

Author

Little, William, Kitzman, Dalane, Cheng, Che-Ping, Little, W C, Kitzman, D W, and Cheng, C P

Subjects
COMPARATIVE studies, DIASTOLE (Cardiac cycle), CARDIAC contraction, HEART physiology, LEFT heart ventricle, HEART failure, ANTIHYPERTENSIVE agents, RESEARCH methodology, MEDICAL cooperation, RESEARCH, EVALUATION research, LOSARTAN, EXERCISE tolerance, PHARMACODYNAMICS
Abstract

Tachycardia accompanying exercise shortens the duration of diastole, reducing the time available for the left ventricular (LV) filling. Thus, the LV must fill more rapidly for the stroke volume to increase (or even be maintained) during exercise. Normally, this is accomplished without requiring an excessive increase in left atrial (LA) pressure by an acceleration of LV relaxation and a fall in LV early diastolic pressure during exercise. This response is lost following the development of heart failure due to systolic dysfunction, both in experimental animals and in patients. In fact, in such situations, LV relaxation slows and LV early diastolic pressure increases due to exercise. Thus, any diastolic dysfunction present at rest in CHF during systolic dysfunction is exacerbated during exercise. Similarly, patients with primary diastolic dysfunction heart failure with preserved systolic function may not be able to augment LV filling rates without an abnormal increase in LA pressure. Thus, diastolic dysfunction may contribute to exercise intolerance, both in systolic dysfunction and primary diastolic dysfunction. Acute studies suggest that treatment with angiotensin II receptor blockers or verapamil may improve exercise tolerance in some patients with primary diastolic dysfunction. [ABSTRACT FROM AUTHOR]

Published
2000
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36. Effects of pregnancy on the electrocardiogram in healthy subjects during strenuous exercise.

Author

Veille, Jean-Claude, Kitzman, Dalane W., Bacevice, Anthony E., Veille, J C, Kitzman, D W, and Bacevice, A E

Subjects
PREGNANT women, EXERCISE, ELECTROCARDIOGRAPHY, HEALTH
Abstract

Objective: Our purpose was to examine the nature and the frequency of electrocardiographic changes at rest and after bicycle exercise in early and late gestation compared with a group of nonpregnant subjects.Study Design: Thirty-nine pregnant subjects had electrically braked bicycle exercise early and late in gestation. Eight nonpregnant subjects served as controls. Twelve-lead electrocardiograms were obtained during rest, exercise, and recovery. All electrocardiograms were analyzed by a cardiologist blinded to subject group and stage of the pregnancy. Data were analyzed by analysis of variance for repeated measures, and contingency tables were used to compare findings at rest and during exercise between the time periods. A p value < 0.05 was considered significant.Results: T-wave inversion in V2 was more frequent in the pregnant than the nonpregnant subjects (p < 0.01). Subjects "late" in pregnancy had significantly fewer Q waves in II, III, and aVF than the nonpregnant group did. With exercise the time to onset of maximum ST depression was significantly shorter during pregnancy.Conclusion: Although minor electrocardiographic charges were found at rest and during exercise between the two groups, these should be considered normal unless associated with significant symptoms. [ABSTRACT FROM AUTHOR]

Published
1996
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41. Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes.

Author

Kosiborod, M. N., Petrie, M. C., Borlaug, B. A., Butler, J., Davies, M. J., Hovingh, G. K., Kitzman, D. W., Møller, D. V., Treppendahl, M. B., Verma, S., Jensen, T. J., Liisberg, K., Lindegaard, M. L., Abhayaratna, W., Ben-Gal, T., Ahmed, F. Z., Chopra, V., Ezekowitz, J. A., Fu, M., and Ito, H.

Subjects
*HEART failure, *TYPE 2 diabetes, *HEART failure patients, *SEMAGLUTIDE, *SYMPTOM burden, *VENTRICULAR ejection fraction
Abstract

BACKGROUND Obesity and type 2 diabetes are prevalent in patients with heart failure with preserved ejection fraction and are characterized by a high symptom burden. No approved therapies specifically target obesity-related heart failure with preserved ejection fraction in persons with type 2 diabetes. METHODS We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. The primary end points were the change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS; scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations) and the change in body weight. Confirmatory secondary end points included the change in 6-minute walk distance; a hierarchical composite end point that included death, heart failure events, and differences in the change in the KCCQ-CSS and 6-minute walk distance; and the change in the C-reactive protein (CRP) level. RESULTS A total of 616 participants underwent randomization. The mean change in the KCCQ-CSS was 13.7 points with semaglutide and 6.4 points with placebo (estimated difference, 7.3 points; 95% confidence interval [CI], 4.1 to 10.4; P<0.001), and the mean percentage change in body weight was -9.8% with semaglutide and -3.4% with placebo (estimated difference, -6.4 percentage points; 95% CI, -7.6 to -5.2; PcO.OOl). The results for the confirmatory secondary end points favored semaglutide over placebo (estimated between-group difference in change in 6-minute walk distance, 14.3 m [95% CI, 3.7 to 24.9; P=0.008]; win ratio for hierarchical composite end point, 1.58 [95% CI, 1.29 to 1.94; P<0.001]; and estimated treatment ratio for change in CRP level, 0.67 [95% CI, 0.55 to 0.80; P<0.001]). Serious adverse events were reported in 55 participants (17.7%) in the semaglutide group and 88 (28.8%) in the placebo group. CONCLUSIONS Among patients with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide led to larger reductions in heart failure-related symptoms and physical limitations and greater weight loss than placebo at 1 year. [ABSTRACT FROM AUTHOR]

Published
2024
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42. Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity.

Author

Kosiborod, M. N., Abildstrøm, S. Z., Borlaug, B. A., Butler, J., Rasmussen, S., Davies, M., Hovingh, G. K., Kitzman, D. W., Lindegaard, M. L., Møller, D. V., Shah, S. J., Treppendahl, M. B., Verma, S., Abhayaratna, W., Ahmed, F. Z., Chopra, V., Ezekowitz, J., Fu, M., Ito, H., and Lelonek, M.

Subjects
*HEART failure, *VENTRICULAR ejection fraction, *HEART failure patients, *SEMAGLUTIDE, *OBESITY, *WEIGHT loss
Abstract

BACKGROUND: Heart failure with preserved ejection fraction is increasing in prevalence and is associated with a high symptom burden and functional impairment, especially in persons with obesity. No therapies have been approved to target obesity-related heart failure with preserved ejection fraction. METHODS: We randomly assigned 529 patients who had heart failure with preserved ejection fraction and a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or higher to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. The dual primary end points were the change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score KCCQ-CSS; scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations) and the change in body weight. Confirmatory secondary end points included the change in the 6-minute walk distance; a hierarchical composite end point that included death, heart failure events, and differences in the change in the KCCQ-CSS and 6-minute walk distance; and the change in the C-reactive protein (CRP) level. RESULTS: The mean change in the KCCQ-CSS was 16.6 points with semaglutide and 8.7 points with placebo (estimated difference, 7.8 points; 95% confidence interval [CI], 4.8 to 10.9; PcO.001), and the mean percentage change in body weight was -13.3% with semaglutide and -2.6% with placebo (estimated difference, -10.7 percentage points; 95% CI, -11.9 to -9.4; P<0.001). The mean change in the 6-minute walk distance was 21.5 m with semaglutide and 1.2 m with placebo (estimated difference, 20.3 m; 95% CI, 8.6 to 32.1; P<0.001). In the analysis of the hierarchical composite end point, semaglutide produced more wins than placebo (win ratio, 1.72; 95% CI, 1.37 to 2.15; PcO.001). The mean percentage change in the CRP level was -43.5% with semaglutide and -7.3% with placebo (estimated treatment ratio, 0. 61; 95% CI, 0.51 to 0.72; PcO.001). Serious adverse events were reported in 35 participants (13.3%) in the semaglutide group and 71 (26.7%) in the placebo group. CONCLUSIONS: In patients with heart failure with preserved ejection fraction and obesity, treatment with semaglutide (2.4 mg) led to larger reductions in symptoms and physical limitations, greater improvements in exercise function, and greater weight loss than placebo. [ABSTRACT FROM AUTHOR]

Published
2023
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43. Efficacy and safety of the novel ultrasound contrast agent perflutren (definity) in patients with suboptimal baseline left ventricular echocardiographic images.

Author

Kitzman, Dalane W., Goldman, Martin E., Kitzman, D W, Goldman, M E, Gillam, L D, Cohen, J L, Aurigemma, G P, and Gottdiener, J S

Subjects
*ECHOCARDIOGRAPHY, *LEFT heart ventricle, *EQUIPMENT & supplies
Abstract

Suboptimal left ventricular (LV) cavity visualization and endocardial border delineation often compromise the clinical utility of echocardiography. This study examines the safety and efficacy of perflutren, a novel ultrasound contrast agent, for LV cavity opacification and endocardial border delineation in patients with suboptimal baseline echocardiograms. In a multicenter, randomized, placebo-controlled, double-blind trial, 211 patients with suspected cardiac disease and suboptimal baseline echocardiograms were enrolled at 17 sites. Two intravenous injections of either placebo (saline) or perflutren (5 or 10 microl/kg) were given approximately 30 minutes apart. Images of the apical 4- and 2-chamber views were acquired and scored. Perflutren opacified the LV cavity after both dosages (5 and 10 microl/kg dosages). Clinically useful contrast was observed in 89% of patients who received perflutren and in 0% of patients who received placebo (p < 0.01). Quantitative assessment of LV opacification with videodensitometry showed similar results. The mean duration of clinically useful contrast was 90 seconds. Improvement in endocardial border delineation was demonstrated in 91% of patients who received perflutren and in 12% of those who received placebo (p < 0.001). Following perflutren, an average of 4 more segments per patient were evaluable compared with baseline. Salvage of nondiagnostic baseline examinations by perflutren was demonstrated in 48% of eligible subjects. The safety profile of perflutren was similar to placebo. These data indicate that administration of perflutren to patients with suboptimal baseline images is well tolerated and provides substantial LV cavity opacification and improvement in endocardial border delineation. [ABSTRACT FROM AUTHOR]

Published
2000
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44. Relation of various degrees of body mass index in patients with systemic hypertension to left ventricular mass, cardiac output, and peripheral resistance (The Hypertension Genetic Epidemiology Network Study).

Author

Palmieri, Vittorio, de Simone, Giovanni, Arnett, Donna K., Bella, Jonathan N., Kitzman, Dalane W., Oberman, Albert, Hopkins, Paul N., Province, Michael A., Devereux, Richard B., Palmieri, V, de Simone, G, Arnett, D K, Bella, J N, Kitzman, D W, Oberman, A, Hopkins, P N, Province, M A, and Devereux, R B

Subjects
*HEART diseases, *CARDIOLOGY
Abstract

The impact of different methods of indexation of left ventricular (LV) mass and systemic hemodynamic variables on prevalences and correlates of cardiovascular abnormalities in relation to level of obesity in populations remains unclear. We evaluated 1,672 participants in the Hypertension Genetic Epidemiology Network Study to investigate the relations of overweight and level of obesity to LV mass and prevalences of LV hypertrophy, abnormal cardiac output, and peripheral resistance detected using different indexations for body size. In our study population, 1,577 subjects were clinically healthy nondiabetic hypertensive and 95 were normotensive normal-weight nondiabetic reference subjects. Fat-free mass (FFM) did not differ between the reference group and the normal-weight hypertensive subjects, and increased with overweight. In hypertensive subjects, LV mass and cardiac output increased and total peripheral resistance decreased with overweight. Indexation of LV mass for FFM or body surface area (BSA) resulted in no difference or even lower prevalence of LV hypertrophy in severely obese compared with normal-weight hypertensive subjects. In contrast, indexation of LV mass for height(2.7) identified an increased prevalence of LV hypertrophy with overweight and obesity. Absolute cardiac output increased and total peripheral resistance decreased with overweight. Prevalence of elevated cardiac output indexed for height(1.83) increased and for elevated total peripheral resistance-height(1.83) index decreased with greater overweight, whereas opposite trends were seen when cardiac output and total peripheral resistance were indexed for BSA or FFM. Thus, in hypertensive subjects, FFM increases with overweight and is directly related to LV mass, stroke volume, and cardiac output, and inversely related to total peripheral resistance. Indexations of LV mass and systemic hemodynamics for FFM or BSA obscured associations of LV hypertrophy and abnormal cardiac and total peripheral resistance indexes with overweight, whereas LV mass/height(2,7), cardiac output/height(1.83), and total peripheral resistance-height(1.83) detected significant preclinical cardiovascular abnormalities with obesity. [ABSTRACT FROM AUTHOR]

Published
2001
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45. Determination of femoral artery endothelial function by phase contrast magnetic resonance imaging.

Author

Alexander, Matthew R., Kitzman, Dalane W., Khaliq, Shazia, Darty, Stephen N., Hamilton, Craig A., Herrington, David M., Link, Kerry M., Hundley, W. Gregory, Alexander, M R, Kitzman, D W, Khaliq, S, Darty, S N, Hamilton, C A, Herrington, D M, Link, K M, and Hundley, W G

Subjects
*CORONARY arteries, *ENDOTHELIUM, *ENDOTHELIUM physiology, *FEMORAL artery, *COMPARATIVE studies, *MAGNETIC resonance imaging, *RESEARCH methodology, *MEDICAL cooperation, *RESEARCH, *EVALUATION research, *PHYSIOLOGY
Abstract

Determines the utility of phase contrast magnetic resonance imaging (PC-MRI) measurements of flow-mediated arterial dilation for characterizing peripheral arterial endothelial function. Difference in the increase in the absolute and percent changes in arterial area for younger versus older patients.

Published
2001
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46. Importance of heart failure with preserved systolic function in patients > or = 65 years of age. CHS Research Group. Cardiovascular Health Study.

Author

Kitzman, Dalane W., Gardin, Julius M., Gottdiener, John S., Arnold, Alice, Boineau, Robin, Aurigemma, Gerald, Marino, Emily K., Lyles, Mary, Cushman, Mary, Enright, Paul L., Kitzman, D W, Gardin, J M, Gottdiener, J S, Arnold, A, Boineau, R, Aurigemma, G, Marino, E K, Lyles, M, Cushman, M, and Enright, P L

Subjects
*CONGESTIVE heart failure, *DISEASES in older people, *ECHOCARDIOGRAPHY
Abstract

Although congestive heart failure (CHF) is a common syndrome among the elderly, there is a relative paucity of population-based data, particularly regarding CHF with normal systolic left ventricular function. A total of 4,842 independent living, community-dwelling subjects aged 66 to 103 years received questionnaires on medical history, family history, personal habits, physical activity, and socioeconomic status, confirmation of pre-existing cardiovascular and cerebrovascular disease, anthropometric measurements, casual seated random-zero blood pressure, forced vital capacity and expiratory volume in 1 second, 12-lead supine electrocardiogram, fasting glucose, creatinine, plasma lipids, carotid artery wall thickness by ultrasonography, and echocardiography-Doppler examinations. Participants with at least 1 confirmed episode of CHF by Cardiovascular Health Study criteria were considered prevalent for CHF. The prevalence of CHF was 8.8% and was associated with increased age, particularly for women, in whom it increased more than twofold from age 65 to 69 years (6.6%) to age > or = 85 years (14%). In multivariate analysis, subjects with CHF were more likely to be older (odds ratio [OR] 1.2 for 5-year difference, men OR 1.1), and more often had a history of myocardial infarction (OR 7.3), atrial fibrillation (OR 3.0), diabetes mellitus (OR 2.1), renal dysfunction (OR 2.0 for creatinine < or = 1.5 mg/ dl), and chronic pulmonary disease (OR 1.8; women only). The echocardiographic correlates of CHF were increased left atrial and ventricular dimensions. Importantly, 55% of subjects with CHF had normal left ventricular systolic function and 80% had either normal or only mildly reduced systolic function. Among subjects with CHF, women had normal systolic function more frequently than men (67% vs 42%; p < 0.001). Thus, CHF is common among community-dwelling elderly. It increases with age and is usually associated with normal systolic LV function, particularly among women. The finding that a large proportion of elderly with CHF have preserved LV systolic function is important because there is a paucity of data to guide management in this dominant subset. [ABSTRACT FROM AUTHOR]

Published
2001
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47. The pathogenesis of acute pulmonary edema associated with hypertension.

Author

Gandhi SK, Powers JC, Nomier A, Fowle K, Kitzman DW, Rankin KM, Little WC, Gandhi, S K, Powers, J C, Nomeir, A M, Fowle, K, Kitzman, D W, Rankin, K M, and Little, W C

Abstract

Background: Patients with acute pulmonary edema often have marked hypertension but, after reduction of the blood pressure, have a normal left ventricular ejection fraction (> or =0.50). However, the pulmonary edema may not have resulted from isolated diastolic dysfunction but, instead, may be due to transient systolic dysfunction, acute mitral regurgitation, or both. Methods: We studied 38 patients (14 men and 24 women; mean [+/-SD] age, 67+/-13 years) with acute pulmonary edema and systolic blood pressure greater than 160 mm Hg. We evaluated the ejection fraction and regional function by two-dimensional Doppler echocardiography, both during the acute episode and one to three days after treatment. Results: The mean systolic blood pressure was 200+/-26 mm Hg during the initial echocardiographic examination and was reduced to 139+/-17 mm Hg (P< 0.01) at the time of the follow-up examination. Despite the marked difference in blood pressure, the ejection fraction was similar during the acute episode (0.50+/-0.15) and after treatment (0.50+/-0.13). The left ventricular regional wall-motion index (the mean value for 16 segments) was also the same during the acute episode (1.6+/-0.6) and after treatment (1.6+/-0.6). No patient had severe mitral regurgitation during the acute episode. Eighteen patients had a normal ejection fraction (at least 0.50) after treatment. In 16 of these 18 patients, the ejection fraction was at least 0.50 during the acute episode. Conclusions: In patients with hypertensive pulmonary edema, a normal ejection fraction after treatment suggests that the edema was due to the exacerbation of diastolic dysfunction by hypertension--not to transient systolic dysfunction or mitral regurgitation. [ABSTRACT FROM AUTHOR]

Published
2001

48. Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial

Author

Hiddo J L Heerspink, Hans-Henrik Parving, Dennis L Andress, George Bakris, Ricardo Correa-Rotter, Fan-Fan Hou, Dalane W Kitzman, Donald Kohan, Hirofumi Makino, John J V McMurray, Joel Z Melnick, Michael G Miller, Pablo E Pergola, Vlado Perkovic, Sheldon Tobe, Tingting Yi, Melissa Wigderson, Dick de Zeeuw, Alicia Elbert, Augusto Vallejos, Andres Alvarisqueta, Laura Maffei, Luis Juncos, Javier de Arteaga, Gustavo Greloni, Eduardo Farias, Alfredo Zucchini, Daniel Vogel, Ana Cusumano, Juan Santos, Margaret Fraenkel, Martin Gallagher, Tim Davis, Shamasunder Acharya, Duncan Cooke, Michael Suranyi, Simon Roger, Nigel Toussaint, Carol Pollock, Doris Chan, Stephen Stranks, Richard MacIsaac, Zoltan Endre, Alice Schmidt, Rudolf Prager, Gert Mayer, Xavier Warling, Michel Jadoul, Jean Hougardy, Chris Vercammen, Bruno Van Vlem, Pieter Gillard, Adriana Costa e Forti, Joao Lindolfo Borges, Luis Santos Canani, Freddy Eliaschewitz, Silmara Leite, Fadlo Fraige Filho, Raphael Paschoalin, Jose Andrade Moura Neto, Luciane Deboni, Irene de Lourdes Noronha, Cintia Cercato, Carlos Alberto Prompt, Maria Zanella, Nelson Rassi, Domingos D'Avila, Rosangela Milagres, Joao Felicio, Roberto Pecoits Filho, Miguel Carlos Riella, Joao Salles, Elizete Keitel, Sergio Draibe, Celso Amodeo, Joseph Youmbissi, Louise Roy, Serge Cournoyer, Shivinder Jolly, Vincent Pichette, Gihad Nesrallah, Harpreet Singh Bajaj, Hasnain Khandwala, Ronnie Aronson, Richard Goluch, Paul Tam, Christian Rabbat, Gordon Bailey, Stephen Chow, Alvaro Castillo, Alfredo Danin Vargas, Fernando Gonzalez, Rodrigo Munoz, Vicente Gutierrez, Gonzalo Godoy, Hongwen Zhao, Zhangsuo Liu, Minghui Zhao, Xiaohui Guo, Benli Su, Shuxia Fu, Yan Xu, Jinkui Yang, Bingyin Shi, Guanqing Xiao, Wei Shi, Chuanming Hao, Changying Xing, Fanfan Hou, Qun Luo, Yuxiu Li, Linong Ji, Li Zuo, Song Wang, Zhaohui Ni, Guohua Ding, Nan Chen, Jiajun Zhao, Weiping Jia, Shengqiang Yu, Jian Weng, Gang Xu, Ping Fu, Shiren Sun, Bicheng Liu, Xiaoqiang Ding, Ivan Rychlik, Alexandra Oplustilova, Dagmar Bartaskova, Vaclava Honova, Hana Chmelickova, Martin Petr, Petr Bucek, Vladimir Tesar, Emil Zahumensky, Johan Povlsen, Kenneth Egstrup, Anna Oczachowska-Kulik, Peter Rossing, Jorma Lahtela, Jorma Strand, Ilkka Kantola, Catherine Petit, Christian Combe, Philippe Zaoui, Vincent Esnault, Pablo Urena Torres, Jean-Michel Halimi, Bertrand Dussol, Tasso Bieler, Klemens Budde, Frank Dellanna, Thomas Segiet, Christine Kosch, Hans Schmidt-Guertler, Isabelle Schenkenberger, Volker Vielhauer, Frank Pistrosch, Mark Alscher, Christoph Hasslacher, Christian Hugo, Anja Muehlfeld, Christoph Wanner, Ploumis Passadakis, Theofanis Apostolou, Nikolaos Tentolouris, Ioannis Stefanidis, Konstantinos Mavromatidis, Vasilios Liakopoulos, Dimitrios Goumenos, Konstantinos Siamopoulos, Vincent Yeung, Risa Ozaki, Samuel Fung, Kathryn Tan, Sydney Tang, Sing Leung Lui, Siu Fai Cheung, Seamus Sreenan, Joseph Eustace, Donal O'Shea, Peter Lavin, Austin Stack, Yoram Yagil, Julio Wainstein, Hilla Knobler, Josef Cohen, Irina Kenis, Deeb Daoud, Yosefa Bar-Dayan, Victor Frajewicki, Faiad Adawi, Loreto Gesualdo, Domenico Santoro, Francesco Marino, Andrea Galfre, Chiara Brunati, Piero Ruggenenti, Giuseppe Rombola, Giuseppe Pugliese, Maura Ravera, Fabio Malberti, Giuseppe Pontoriero, Teresa Rampino, Salvatore De Cosmo, Ciro Esposito, Felice Nappi, Cataldo Abaterusso, Giuseppe Conte, Vincenzo Panichi, Davide Lauro, Giovambattista Capasso, Domenico Russo, Jiichi Anzai, Motoji Naka, Keita Ato, Tetsuro Tsujimoto, Toshinori Nimura, Eitaro Nakashima, Tetsuro Takeda, Shinya Fujii, Kunihisa Kobayashi, Hideaki Iwaoka, Koji Nagayama, Hiroyuki Harada, Hajime Maeda, Rui Kishimoto, Tadashi Iitsuka, Naoki Itabashi, Ryuichi Furuya, Yoshitaka Maeda, Daishiro Yamada, Nobuhiro Sasaki, Hiromitsu Sasaki, Shinichiro Ueda, Naoki Kashihara, Shuichi Watanabe, Takehiro Nakamura, Hidetoshi Kanai, Yuichiro Makita, Keiko Ono, Noriyuki Iehara, Daisuke Goto, Keiichiro Kosuge, Kenichi Tsuchida, Toshiaki Sato, Takashi Sekikawa, Hideki Okamoto, Tsuyoshi Tanaka, Naoko Ikeda, Takenobu Tadika, Koji Mukasa, Takeshi Osonoi, Fuminori Hirano, Motonobu Nishimura, Yuko Yambe, Yukio Tanaka, Makoto Ujihara, Takashi Sakai, Mitsuo Imura, Yutaka Umayahara, Shinya Makino, Jun Nakazawa, Yukinari Yamaguchi, Susumu Kashine, Hiroaki Miyaoka, Katsunori Suzuki, Toshihiko Inoue, Sou Nagai, Nobuyuki Sato, Masahiro Yamamoto, Noriyasu Taya, Akira Fujita, Akira Matsutani, Yugo Shibagaki, Yuichi Sato, Akira Yamauchi, Masahiro Tsutsui, Tamayo Ishiko, Shizuka Kaneko, Nobuyuki Azuma, Hirofumi Matsuda, Yasuhiro Hashiguchi, Yukiko Onishi, Mikiya Tokui, Munehide Matsuhisa, Arihiro Kiyosue, Junji Shinoda, Kazuo Ishikawa, Ghazali Ahmad, Shalini Vijayasingham, Nor Azizah Aziz, Zanariah Hussein, Yin Khet Fung, Wan Hasnul Halimi Wan Hassan, Hin Seng Wong, Bak Leong Goh, Norhaliza Mohd Ali, Nor Shaffinaz Yusuf Azmi Merican, Indralingam Vaithilingam, Nik Nur Fatnoon Nik Ahmad, Noor Adam, Norlela Sukor, V Paranthaman P Vengadasalam, Khalid Abdul Kadir, Mafauzy Mohamed, Karina Renoirte Lopez, Aniceto Leguizamo-Dimas, Alfredo Chew Wong, Jose Chevaile-Ramos, Jose Gonzalez Gonzalez, Raul Rico Hernandez, Jose Nino-Cruz, Leobardo Sauque Reyna, Guillermo Gonzalez-Galvez, Magdalena Madero Rovalo, Tomasso Bochicchio-Ricardelli, Jorge Aldrete, Jaime Carranza-Madrigal, Liffert Vogt, Peter Smak Gregoor, JNM Barendregt, Peter Luik, Ronald Gansevoort, Gozewijn Laverman, Helen Pilmore, Helen Lunt, John Baker, Steven Miller, Kannaiyan Rabindranath, Luis Zapata-Rincon, Rolando Vargas-Gonzales, Jorge Calderon Ticona, Augusto Dextre Espinoza, Jose Burga Nunez, Carlos Antonio Zea-Nunez, Benjamin Herrada Orue, Boris Medina-Santander, Cesar Delgado-Butron, Julio Farfan-Aspilcueta, Stanislaw Mazur, Miroslaw Necki, Michal Wruk, Katarzyna Klodawska, Grazyna Popenda, Ewa Skokowska, Malgorzata Arciszewska, Andrzej Wiecek, Kazimierz Ciechanowski, Michal Nowicki, Rita Birne, Antonio Cabrita, Aura Ramos, Manuel Anibal Antunes 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Tkac, Aniko Oroszova, Jozef Fekete, Jaroslav Rosenberger, Ida Obetkova, Alla Fulopova, Eva Kolesarova, Katarina Raslova, Peter Smolko, Adrian Oksa, Larry Distiller, Julien Trokis, Luthando Adams, Hemant Makan, Padaruth Ramlachan, Essack Mitha, Kathleen Coetzee, Zelda Punt, Qasim Bhorat, Puvenesvari Naiker, Graham Ellis, Louis Van Zyl, Kwan Woo Lee, Min Seon Kim, Soon-Jib Yoo, Kun Ho Yoon, Yong-Wook Cho, Tae-Sun Park, Sang Yong Kim, Moon-Gi Choi, Tae Keun Oh, Kang-Wook Lee, Ho Sang Shon, Sung Hwan Suh, Byung-Joon Kim, Kim Doo-Man, Joo Hark Yi, Sang Ah Lee, Ho Chan Cho, Sin-Gon Kim, Dae-Ryong Cha, Ji A Seo, Kyung Mook Choi, Jeong-Taek Woo, Kyu Jeung Ahn, Jae Hyuk Lee, In-Joo Kim, Moon-Kyu Lee, Hak Chul Jang, Kyong-Soo Park, Beom Seok Kim, Ji Oh Mok, Mijung Shin, Sun Ae Yoon, Il-Seong Nam-Goong, Choon Hee Chung, Tae Yang Yu, Hyoung Woo Lee, Alfonso Soto Gonzalez, Jaume Almirall, Jesus Egido, Francesca Calero Gonzalez, Gema Fernandez Fresnedo, Ildefonso Valera Cortes, Manuel Praga Terente, Isabel Garcia Mendez, Juan Navarro Gonzalez, Jose Herrero Calvo, Secundino Cigarran Guldris, Mario Prieto Velasco, Jose Ignacio Minguela Pesquera, Antonio Galan, Julio Pascual, Maria Marques Vidas, Judith Martins Munoz, Jose Rodriguez-Perez, Cristina Castro-Alonso, Josep Bonet Sol, Daniel Seron, Elvira Fernandez Giraldez, Javier Arrieta Lezama, Nuria Montero, Julio Hernandez-Jaras, Rafael Santamaria Olmo, Jose Ramon Molas Coten, Olof Hellberg, Bengt Fellstrom, Andreas Bock, Dee Pei, Ching-Ling Lin, Kai-Jen Tien, Ching-Chu Chen, Chien-Ning Huang, Ju-Ying Jiang, Du-An Wu, Chih-Hsun Chu, Shih-Ting Tseng, Jung-Fu Chen, Cho-Tsan Bau, Wayne Sheu, Mai-Szu Wu, Ramazan Sari, Siren Sezer, Alaattin Yildiz, Ilhan Satman, Betul Kalender, Borys Mankovskyy, Ivan Fushtey, Mykola Stanislavchuk, Mykola Kolenyk, Iryna Dudar, Viktoriia Zolotaikina, Orest Abrahamovych, Tetyana Kostynenko, Olena Petrosyan, Petro Kuskalo, Olga Galushchak, Oleg Legun, Ivan Topchii, Liliya Martynyuk, Vasyl Stryzhak, Svitlana Panina, Sergii Tkach, Vadym Korpachev, Peter Maxwell, Luigi Gnudi, Sui Phin Kon, Hilary Tindall, Phillip Kalra, Patrick Mark, Dipesh Patel, Mohamed El-Shahawy, Liqun Bai, Romanita Nica, Yeong-Hau Lien, Judson Menefee, Robert Busch, Alan Miller, Azazuddin Ahmed, Ahmed Arif, Joseph Lee, Sachin Desai, Shweta Bansal, Marie Bentsianov, Mario Belledonne, Charles Jere, Raul Gaona, Gregory Greenwood, Osvaldo Brusco, Mark Boiskin, Diogo Belo, Raffi Minasian, Naveen Atray, Mary Lawrence, John Taliercio, Pablo Pergola, David Scott, German Alvarez, Bradley Marder, Thomas Powell, Wa'el Bakdash, George Stoica, Christopher McFadden, Marc Rendell, Jonathan Wise, Audrey Jones, Michael Jardula, Ivy-Joan Madu, Freemu Varghese, Brian Tulloch, Ziauddin Ahmed, Melanie Hames, Imran Nazeer, Newman Shahid, Rekha John, Manuel Montero, David Fitz-Patrick, Lawrence Phillips, Antonio Guasch, Elena Christofides, Aijaz Gundroo, Mohammad Amin, Cynthia Bowman-Stroud, Michael Link, Laura Mulloy, Michael Nammour, Tarik Lalwani, Lenita Hanson, Adam Whaley-Connell, Lee Herman, Rupi Chatha, Sayed Osama, Kenneth Liss, Zeid Kayali, Anuj Bhargava, Ezra Israel, Alfredo Peguero-Rivera, Michael Fang, Judith Slover, Elena Barengolts, Jose Flores, Rosemary Muoneke, Virginia Savin, Stella Awua-Larbi, Andrew Levine, George Newman, Laden Golestaneh, Guillermo Bohm, Efrain Reisin, Lucita Cruz, Robert Weiss, Franklin Zieve, Edward Horwitz, Peale Chuang, James Mersey, John Manley, Ronald Graf, Fadi Bedros, Sudhir Joshi, Juan Frias, Ali Assefi, Andrew O'Shaughnessy, Roman Brantley, Todd Minga, David Tietjen, Samuel Kantor, Aamir Jamal, Ramon Guadiz, Kenneth Hershon, Peter Bressler, Nelson Kopyt, Harold Cathcart, Scott Bloom, Ronald Reichel, Samer Nakhle, Emily Dulude, Joshua Tarkan, Penelope Baker, Steven Zeig, Jaynier Moya Hechevarria, Armando Ropero-Cartier, Gilda De la Calle, Ankur Doshi, Fadi Saba, Teresa Sligh, Sylvia Shaw, Jayant Kumar, Harold Szerlip, George Bayliss, Alan Perlman, Lakhi Sakhrani, Steven Gouge, Georges Argoud, Idalia Acosta, John Elder, Sucharit Joshi, John Sensenbrenner, Steven Vicks, Roberto Mangoo-Karim, Claude Galphin, Carlos Leon-Forero, John Gilbert, Eric Brown, Adeel Ijaz, Salman Butt, Mariana Markell, Carlos Arauz-Pacheco, Lance Sloan, Odilon Alvarado, Serge Jabbour, Eric Simon, Anjay Rastogi, Sam James, Karen Hall, John Melish, Brad Dixon, Allen Adolphe, Csaba Kovesdy, Srinivasan Beddhu, Richard Solomon, Ronald Fernando, Ellis Levin, Charuhas Thakar, Brooks Robey, David Goldfarb, Linda Fried, Geetha Maddukuri, Stephen Thomson, Andrew Annand, Saeed Kronfli, Paramjit Kalirao, Rebecca Schmidt, Neera Dahl, Samuel Blumenthal, Debra Weinstein, Ove Ostergaard, Talia Weinstein, Yasuhiro Ono, Murat Yalcin, Shahana Karim, APH - Health Behaviors & Chronic Diseases, Nephrology, ACS - Amsterdam Cardiovascular Sciences, ACS - Microcirculation, Biomedical Signals and Systems, UCL - SSS/IREC/NEFR - Pôle de Néphrologie, UCL - (SLuc) Service de néphrologie, Groningen Kidney Center (GKC), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), Heerspink, H. J. L., Parving, H. -H., Andress, D. L., Bakris, G., Correa-Rotter, R., Hou, F. -F., Kitzman, D. W., Kohan, D., Makino, H., Mcmurray, J. J. V., Melnick, J. Z., Miller, M. G., Pergola, P. E., Perkovic, V., Tobe, S., Yi, T., Wigderson, M., de Zeeuw, D., Elbert, A., Vallejos, A., Alvarisqueta, A., Maffei, L., Juncos, L., de Arteaga, J., Greloni, G., Farias, E., Zucchini, A., Vogel, D., Cusumano, A., Santos, J., Fraenkel, M., Gallagher, M., Davis, T., Acharya, S., Cooke, D., Suranyi, M., Roger, S., Toussaint, N., Pollock, C., Chan, D., Stranks, S., Macisaac, R., Endre, Z., Schmidt, A., Prager, R., Mayer, G., Warling, X., Jadoul, M., Hougardy, J., Vercammen, C., Van Vlem, B., Gillard, P., Costa e Forti, A., Borges, J. L., Santos Canani, L., Eliaschewitz, F., Leite, S., Fraige Filho, F., Paschoalin, R., Moura Neto, J. A., Deboni, L., de Lourdes Noronha, I., Cercato, C., Prompt, C. A., Zanella, M., Rassi, N., D'Avila, D., Milagres, R., Felicio, J., Pecoits Filho, R., Riella, M. 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S., Khandwala, H., Aronson, R., Goluch, R., Tam, P., Rabbat, C., Bailey, G., Chow, S., Castillo, A., Danin Vargas, A., Gonzalez, F., Munoz, R., Gutierrez, V., Godoy, G., Zhao, H., Liu, Z., Zhao, M., Guo, X., Su, B., Fu, S., Xu, Y., Yang, J., Shi, B., Xiao, G., Shi, W., Hao, C., Xing, C., Hou, F., Luo, Q., Li, Y., Ji, L., Zuo, L., Wang, S., Ni, Z., Ding, G., Chen, N., Zhao, J., Jia, W., Yu, S., Weng, J., Xu, G., Fu, P., Sun, S., Liu, B., Ding, X., Rychlik, I., Oplustilova, A., Bartaskova, D., Honova, V., Chmelickova, H., Petr, M., Bucek, P., Tesar, V., Zahumensky, E., Povlsen, J., Egstrup, K., Oczachowska-Kulik, A., Rossing, P., Lahtela, J., Strand, J., Kantola, I., Petit, C., Combe, C., Zaoui, P., Esnault, V., Urena Torres, P., Halimi, J. -M., Dussol, B., Bieler, T., Budde, K., Dellanna, F., Segiet, T., Kosch, C., Schmidt-Guertler, H., Schenkenberger, I., Vielhauer, V., Pistrosch, F., Alscher, M., Hasslacher, C., Hugo, C., Muehlfeld, A., Wanner, C., Passadakis, P., Apostolou, T., Tentolouris, N., Stefanidis, I., Mavromatidis, K., Liakopoulos, V., Goumenos, D., Siamopoulos, K., Yeung, V., Ozaki, R., Fung, S., Tan, K., Tang, S., Lui, S. L., Cheung, S. F., Sreenan, S., Eustace, J., O'Shea, D., Lavin, P., Stack, A., Yagil, Y., Wainstein, J., Knobler, H., Cohen, J., Kenis, I., Daoud, D., Bar-Dayan, Y., Frajewicki, V., Adawi, F., Gesualdo, L., Santoro, D., Marino, F., Galfre, A., Brunati, C., Ruggenenti, P., Rombola, G., Pugliese, G., Ravera, M., Malberti, F., Pontoriero, G., Rampino, T., De Cosmo, S., Esposito, C., Nappi, F., Abaterusso, C., Conte, G., Panichi, V., Lauro, D., Capasso, G., Russo, D., Anzai, J., Naka, M., Ato, K., Tsujimoto, T., Nimura, T., Nakashima, E., Takeda, T., Fujii, S., Kobayashi, K., Iwaoka, H., Nagayama, K., Harada, H., Maeda, H., Kishimoto, R., Iitsuka, T., Itabashi, N., Furuya, R., Maeda, Y., Yamada, D., Sasaki, N., Sasaki, H., Ueda, S., Kashihara, N., Watanabe, S., Nakamura, T., Kanai, H., Makita, Y., Ono, K., Iehara, N., Goto, D., Kosuge, K., Tsuchida, K., Sato, T., Sekikawa, T., Okamoto, H., Tanaka, T., Ikeda, N., Tadika, T., Mukasa, K., Osonoi, T., Hirano, F., Nishimura, M., Yambe, Y., Tanaka, Y., Ujihara, M., Sakai, T., Imura, M., Umayahara, Y., Makino, S., Nakazawa, J., Yamaguchi, Y., Kashine, S., Miyaoka, H., Suzuki, K., Inoue, T., Nagai, S., Sato, N., Yamamoto, M., Taya, N., Fujita, A., Matsutani, A., Shibagaki, Y., Sato, Y., Yamauchi, A., Tsutsui, M., Ishiko, T., Kaneko, S., Azuma, N., Matsuda, H., Hashiguchi, Y., Onishi, Y., Tokui, M., Matsuhisa, M., Kiyosue, A., Shinoda, J., Ishikawa, K., Ahmad, G., Vijayasingham, S., Aziz, N. A., Hussein, Z., Fung, Y. K., Hassan, W. H. H. W., Wong, H. S., Goh, B. L., Ali, N. M., Merican, N. S. Y. A., Vaithilingam, I., Nik Ahmad, N. N. F., Adam, N., Sukor, N., Vengadasalam, V. P. P., Abdul Kadir, K., Mohamed, M., Renoirte Lopez, K., Leguizamo-Dimas, A., Chew Wong, A., Chevaile-Ramos, J., Gonzalez Gonzalez, J., Rico Hernandez, R., Nino-Cruz, J., Sauque Reyna, L., Gonzalez-Galvez, G., Madero Rovalo, M., Bochicchio-Ricardelli, T., Aldrete, J., Carranza-Madrigal, J., Vogt, L., Smak Gregoor, P., Barendregt, J. N. M., Luik, P., Gansevoort, R., Laverman, G., Pilmore, H., Lunt, H., Baker, J., Miller, S., Rabindranath, K., Zapata-Rincon, L., Vargas-Gonzales, R., Calderon Ticona, J., Dextre Espinoza, A., Burga Nunez, J., Zea-Nunez, C. A., Herrada Orue, B., Medina-Santander, B., Delgado-Butron, C., Farfan-Aspilcueta, J., Mazur, S., Necki, M., Wruk, M., Klodawska, K., Popenda, G., Skokowska, E., Arciszewska, M., Wiecek, A., Ciechanowski, K., Nowicki, M., Birne, R., Cabrita, A., Ramos, A., Antunes Ferreira, M. A., Matta Fontanet, E., Alcantara-Gonzalez, A. A., Comulada-Rivera, A., Galindo Ramos, E., Cangiano, J., Quesada-Suarez, L., Calderon Ortiz, R., Vazquez-Tanus, J., Burgos-Calderon, R., Rosado, C., Hancu, N., Pintilei, E., Mistodie, C., Bako, G., Ionutiu, L., Petrica, L., Timar, R., Tuta, L., Duma, L., Tutescu, A., Ivanova, S., Essaian, A., Zrazhevskiy, K., Tomilina, N., Smolyarchuk, E., Kuzin, A., Lantseva, O., Karpova, I., Shamkhalova, M., Liberanskaya, N., Yavdosyuk, A., Shvarts, Y., Bardymova, T., Blagoveshchenskaya, O., Solovev, O., Rechkova, E., Pikalova, N., Pavlova, M., Kolmakova, E., Sayfutdinov, R., Villevalde, S., Koziolova, N., Martynenko, V., Marasaev, V., Maksudova, A., Sigitova, O., Mordovin, V., Klimontov, V., Samoylova, Y., Karonova, T., Yeoh, L. Y., Teo, B. W., Foo, M. W. Y., Liew, A., Tkac, I., Oroszova, A., Fekete, J., Rosenberger, J., Obetkova, I., Fulopova, A., Kolesarova, E., Raslova, K., Smolko, P., Oksa, A., Distiller, L., Trokis, J., Adams, L., Makan, H., Ramlachan, P., Mitha, E., Coetzee, K., Punt, Z., Bhorat, Q., Naiker, P., Ellis, G., Van Zyl, L., Lee, K. W., Kim, M. S., Yoo, S. -J., Yoon, K. H., Cho, Y. -W., Park, T. -S., Kim, S. Y., Choi, M. -G., Oh, T. K., Lee, K. -W., Shon, H. S., Suh, S. H., Kim, B. -J., Doo-Man, K., Yi, J. H., Lee, S. A., Cho, H. C., Kim, S. -G., Cha, D. -R., Seo, J. A., Choi, K. M., Woo, J. -T., Ahn, K. J., Lee, J. H., Kim, I. -J., Lee, M. -K., Jang, H. C., Park, K. -S., Kim, B. S., Mok, J. O., Shin, M., Yoon, S. A., Nam-Goong, I. -S., Chung, C. H., Yu, T. Y., Lee, H. W., Soto Gonzalez, A., Almirall, J., Egido, J., Calero Gonzalez, F., Fernandez Fresnedo, G., Valera Cortes, I., Praga Terente, M., Garcia Mendez, I., Navarro Gonzalez, J., Herrero Calvo, J., Cigarran Guldris, S., Prieto Velasco, M., Minguela Pesquera, J. I., Galan, A., Pascual, J., Marques Vidas, M., Martins Munoz, J., Rodriguez-Perez, J., Castro-Alonso, C., Bonet Sol, J., Seron, D., Fernandez Giraldez, E., Arrieta Lezama, J., Montero, N., Hernandez-Jaras, J., Santamaria Olmo, R., Molas Coten, J. R., Hellberg, O., Fellstrom, B., Bock, A., Pei, D., Lin, C. -L., Tien, K. -J., Chen, C. -C., Huang, C. -N., Jiang, J. -Y., Wu, D. -A., Chu, C. -H., Tseng, S. -T., Chen, J. -F., Bau, C. -T., Sheu, W., Wu, M. -S., Sari, R., Sezer, S., Yildiz, A., Satman, I., Kalender, B., Mankovskyy, B., Fushtey, I., Stanislavchuk, M., Kolenyk, M., Dudar, I., Zolotaikina, V., Abrahamovych, O., Kostynenko, T., Petrosyan, O., Kuskalo, P., Galushchak, O., Legun, O., Topchii, I., Martynyuk, L., Stryzhak, V., Panina, S., Tkach, S., Korpachev, V., Maxwell, P., Gnudi, L., Kon, S. P., Tindall, H., Kalra, P., Mark, P., Patel, D., El-Shahawy, M., Bai, L., Nica, R., Lien, Y. -H., Menefee, J., Busch, R., Miller, A., Ahmed, A., Arif, A., Lee, J., Desai, S., Bansal, S., Bentsianov, M., Belledonne, M., Jere, C., Gaona, R., Greenwood, G., Brusco, O., Boiskin, M., Belo, D., Minasian, R., Atray, N., Lawrence, M., Taliercio, J., Pergola, P., Scott, D., Alvarez, G., Marder, B., Powell, T., Bakdash, W., Stoica, G., Mcfadden, C., Rendell, M., Wise, J., Jones, A., Jardula, M., Madu, I. -J., Varghese, F., Tulloch, B., Ahmed, Z., Hames, M., Nazeer, I., Shahid, N., John, R., Montero, M., Fitz-Patrick, D., Phillips, L., Guasch, A., Christofides, E., Gundroo, A., Amin, M., Bowman-Stroud, C., Link, M., Mulloy, L., Nammour, M., Lalwani, T., Hanson, L., Whaley-Connell, A., Herman, L., Chatha, R., Osama, S., Liss, K., Kayali, Z., Bhargava, A., Israel, E., Peguero-Rivera, A., Fang, M., Slover, J., Barengolts, E., Flores, J., Muoneke, R., Savin, V., Awua-Larbi, S., Levine, A., Newman, G., Golestaneh, L., Bohm, G., Reisin, E., Cruz, L., Weiss, R., Zieve, F., Horwitz, E., Chuang, P., Mersey, J., Manley, J., Graf, R., Bedros, F., Joshi, S., Frias, J., Assefi, A., O'Shaughnessy, A., Brantley, R., Minga, T., Tietjen, D., Kantor, S., Jamal, A., Guadiz, R., Hershon, K., Bressler, P., Kopyt, N., Cathcart, H., Bloom, S., Reichel, R., Nakhle, S., Dulude, E., Tarkan, J., Baker, P., Zeig, S., Moya Hechevarria, J., Ropero-Cartier, A., De la Calle, G., Doshi, A., Saba, F., Sligh, T., Shaw, S., Kumar, J., Szerlip, H., Bayliss, G., Perlman, A., Sakhrani, L., Gouge, S., Argoud, G., Acosta, I., Elder, J., Sensenbrenner, J., Vicks, S., Mangoo-Karim, R., Galphin, C., Leon-Forero, C., Gilbert, J., Brown, E., Ijaz, A., Butt, S., Markell, M., Arauz-Pacheco, C., Sloan, L., Alvarado, O., Jabbour, S., Simon, E., Rastogi, A., James, S., Hall, K., Melish, J., Dixon, B., Adolphe, A., Kovesdy, C., Beddhu, S., Solomon, R., Fernando, R., Levin, E., Thakar, C., Robey, B., Goldfarb, D., Fried, L., Maddukuri, G., Thomson, S., Annand, A., Kronfli, S., Kalirao, P., Schmidt, R., Dahl, N., Blumenthal, S., Weinstein, D., Ostergaard, O., Weinstein, T., Ono, Y., Yalcin, M., Karim, S., Pathology/molecular and cellular medicine, Diabetes Pathology & Therapy, and Diabetes Clinic

Subjects
Male, endothelin, albuminuria, nephropathy, inhibition, Diabetes Mellitus, Type 2/drug therapy, Endocrinology, Diabetes and Metabolism, Placebo-controlled study, Administration, Oral, 030204 cardiovascular system & hematology, Settore MED/13 - Endocrinologia, chemistry.chemical_compound, 0302 clinical medicine, ENDOTHELIN, 80 and over, Diabetic Nephropathies, 030212 general & internal medicine, Renal Insufficiency, Chronic, Aged, 80 and over, Diabetic Nephropathies/blood, General Medicine, Middle Aged, Atrasentan/administration & dosage, Editorial Commentary, Treatment Outcome, Nephrology, Creatinine, Administration, young adult, Female, medicine.symptom, Glomerular filtration rate, Type 2, Endothelin A Receptor Antagonists/administration & dosage, medicine.drug, Glomerular Filtration Rate, Human, Oral, Adult, medicine.medical_specialty, ALBUMINURIA, Endothelin A Receptor Antagonists, NEPHROPATHY, Urology, INHIBITION, Renal function, Serum Albumin, Human, Placebo, Nephropathy, 03 medical and health sciences, Young Adult, Double-Blind Method, Atresentan, diabetes, chronic kidney disease, medicine, Diabetes Mellitus, Aged, Atrasentan, Diabetes Mellitus, Type 2, Humans, Renal Insufficiency, Chronic, Serum Albumin, business.industry, Creatinine/blood, medicine.disease, Serum Albumin, Human/urine, n/a OA procedure, chemistry, Albuminuria, Renal Insufficiency, Chronic/blood, business, aged, 80 and over, Kidney disease
Abstract

Background Short-term treatment for people with type 2 diabetes using a low dose of the selective endothelin A receptor antagonist atrasentan reduces albuminuria without causing significant sodium retention. We report the long-term effects of treatment with atrasentan on major renal outcomes.Methods We did this double-blind, randomised, placebo-controlled trial at 689 sites in 41 countries. We enrolled adults aged 18-85 years with type 2 diabetes, estimated glomerular filtration rate (eGFR) 25-75 mL/min per 1.73 m(2) of body surface area, and a urine albumin-to-creatinine ratio (UACR) of 300-5000 mg/g who had received maximum labelled or tolerated renin-angiotensin system inhibition for at least 4 weeks. Participants were given atrasentan 0.75 mg orally daily during an enrichment period before random group assignment. Those with a UACR decrease of at least 30% with no substantial fluid retention during the enrichment period (responders) were included in the double-blind treatment period. Responders were randomly assigned to receive either atrasentan 0.75 mg orally daily or placebo. All patients and investigators were masked to treatment assignment. The primary endpoint was a composite of doubling of serum creatinine (sustained for >= 30 days) or end-stage kidney disease (eGFR = 90 days, chronic dialysis for >= 90 days, kidney transplantation, or death from kidney failure) in the intention-to-treat population of all responders. Safety was assessed in all patients who received at least one dose of their assigned study treatment. The study is registered with ClinicalTrials. gov, number NCT01858532.Findings Between May 17, 2013, and July 13, 2017, 11 087 patients were screened; 5117 entered the enrichment period, and 4711 completed the enrichment period. Of these, 2648 patients were responders and were randomly assigned to the atrasentan group (n=1325) or placebo group (n=1323). Median follow-up was 2.2 years (IQR 1.4-2.9). 79 (6.0%) of 1325 patients in the atrasentan group and 105 (7.9%) of 1323 in the placebo group had a primary composite renal endpoint event (hazard ratio [HR] 0.65 [95% CI 0.49-0.88]; p=0.0047). Fluid retention and anaemia adverse events, which have been previously attributed to endothelin receptor antagonists, were more frequent in the atrasentan group than in the placebo group. Hospital admission for heart failure occurred in 47 (3.5%) of 1325 patients in the atrasentan group and 34 (2.6%) of 1323 patients in the placebo group (HR 1.33 [95% CI 0.85-2.07]; p=0.208). 58 (4.4%) patients in the atrasentan group and 52 (3.9%) in the placebo group died (HR 1.09 [95% CI 0.75-1.59]; p=0.65).Interpretation Atrasentan reduced the risk of renal events in patients with diabetes and chronic kidney disease who were selected to optimise efficacy and safety. These data support a potential role for selective endothelin receptor antagonists in protecting renal function in patients with type 2 diabetes at high risk of developing end-stage kidney disease. Copyright (C) 2019 Elsevier Ltd. All rights reserved.

Published
2019
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49. Reproducibility of cardiopulmonary exercise testing in elderly patients with congestive heart failure.

Author

Marburger CT, Brubaker PH, Pollock WE, Morgan TM, Kitzman DW, Marburger, C T, Brubaker, P H, Pollock, W E, Morgan, T M, and Kitzman, D W

Abstract

Elderly patients with congestive heart failure, including those with preserved systolic function, underwent maximal cardiopulmonary exercise testing. Maximal exercise oxygen consumption, exercise time, heart rate, respiratory exchange ratio, and ventilatory anaerobic threshold showed good reproducibility. [ABSTRACT FROM AUTHOR]

Published
1998
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50. Left ventricular diastolic filling in the elderly: the cardiovascular health study.

Author

Gardin, Julius M., Arnold, Alice M., Bild, Diane E., Smith, Vivienne-Elizabeth, Lima, Joao A.C., Klopfenstein, H. Sidney, Kitzman, Dalane W., Gardin, J M, Arnold, A M, Bild, D E, Smith, V E, Lima, J A, Klopfenstein, H S, and Kitzman, D W

Subjects
*LEFT heart ventricle, *CARDIOVASCULAR diseases in old age, *DIASTOLE (Cardiac cycle), *AGING, *HEALTH of older people
Abstract

Changes in left ventricular (LV) diastolic function (e.g., as measured by transmitral flow velocity) are known to occur with aging. In addition, impaired LV diastolic function plays an important role in such cardiovascular disorders common in the elderly as hypertension, ischemic heart disease, and congestive heart failure (CHF). Participants in the Cardiovascular Health Study, a multicenter study of community-dwelling men (n=2,239) and women (n=2,962) > or = 65 years of age, underwent an extensive baseline evaluation, including echocardiography. Early diastolic LV Doppler (transmitral) peak filling velocity decreased, and peak late diastolic (atrial) velocity increased with age in multivariate analyses (all p <0.001). Early and late diastolic peak filling velocities were both significantly higher in women than in men, even after adjustment for body surface area (or height and weight). In multivariate models in the entire cohort and a healthy subgroup (n=703), gender, age, heart rate, and blood pressure (BP) were most strongly related to early and late diastolic transmitral peak velocities. Early and late diastolic peak velocities both increased with increases in systolic BP and decreased with increases in diastolic BP (p <0.001). Doppler transmitral velocities were compared among health status subgroups. In multiple regression models adjusted for other covariates, and in analysis of variance models examining differences across subgroups adjusted only for age, the subgroup with CHF had the highest early diastolic peak velocities. All clinical disease subgroups had higher late diastolic peak velocities than the healthy subgroup, with the subgroups with either CHF or hypertension having the highest age-adjusted means. The subgroup with hypertension had the lowest ratio of early-to-late diastolic peak velocity, and men with CHF had the highest ratio. These findings are consistent with previous reports that hypertensive subjects exhibit an abnormal relaxation pattern, whereas patients with CHF develop a pattern suggestive of an increased early diastolic left atrial-LV pressure gradient. [ABSTRACT FROM AUTHOR]

Published
1998
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