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251. Site selection for heart failure clinical trials in the USA

Author

Harinstein, Matthew E., primary, Butler, Javed, additional, Greene, Stephen J., additional, Fonarow, Gregg C., additional, Stockbridge, Norman L., additional, O’Connor, Christopher M., additional, Pfeffer, Marc A., additional, Mehra, Mandeep R., additional, Solomon, Scott D., additional, Yancy, Clyde W., additional, Fiuzat, Mona, additional, Mentz, Robert J., additional, Collins, Sean P., additional, McMurray, John J. V., additional, Vaduganathan, Muthiah, additional, Dunnmon, Preston M., additional, Rosano, Giuseppe M. C., additional, Dinh, Wilfried, additional, Misselwitz, Frank, additional, Bonow, Robert O., additional, and Gheorghiade, Mihai, additional

Published
2015
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253. Charting a roadmap for heart failure biomarker studies.

Author

Ahmad, Tariq, Ahmad, Tariq, Fiuzat, Mona, Pencina, Michael J, Geller, Nancy L, Zannad, Faiez, Cleland, John GF, Snider, James V, Blankenberg, Stephan, Adams, Kirkwood F, Redberg, Rita F, Kim, Jae B, Mascette, Alice, Mentz, Robert J, O'Connor, Christopher M, Felker, G Michael, Januzzi, James L, Ahmad, Tariq, Ahmad, Tariq, Fiuzat, Mona, Pencina, Michael J, Geller, Nancy L, Zannad, Faiez, Cleland, John GF, Snider, James V, Blankenberg, Stephan, Adams, Kirkwood F, Redberg, Rita F, Kim, Jae B, Mascette, Alice, Mentz, Robert J, O'Connor, Christopher M, Felker, G Michael, and Januzzi, James L

Abstract

Heart failure is a syndrome with a pathophysiological basis that can be traced to dysfunction in several interconnected molecular pathways. Identification of biomarkers of heart failure that allow measurement of the disease on a molecular level has resulted in enthusiasm for their use in prognostication and selection of appropriate therapies. However, despite considerable amounts of information available on numerous biomarkers, inconsistent research methodologies and lack of clinical correlations have made bench-to-bedside translations rare and left the literature with countless publications of varied quality. There is a need for a systematic and collaborative approach aimed at definitively studying the clinical benefits of novel biomarkers. In this review, on the basis of input from academia, industry, and governmental agencies, we propose a systematized approach based on adherence to specific quality measures for studies looking to augment current prediction model or use biomarkers to tailor therapeutics. We suggest that study quality, rather than results, should determine publication and propose a system for grading biomarker studies. We outline the need for collaboration between clinical investigators and statisticians to introduce more advanced statistical methodologies into the field of biomarkers that would allow for data from a large number of variables to be distilled into clinically actionable information. Lastly, we propose the creation of a heart failure biomarker consortium that would allow for a comprehensive list of biomarkers to be concomitantly analyzed in a pooled sample of randomized clinical trials and hypotheses to be generated for testing in biomarker-guided trials. Such a consortium could collaborate in sharing samples to identify biomarkers, undertake meta-analyses on completed trials, and spearhead clinical trials to test the clinical utility of new biomarkers.

Published
2014

254. Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

Author

Felker, G. Michael, Ahmad, Tariq, Anstrom, Kevin J., Adams, Kirkwood F., Cooper, Lawton S., Ezekowitz, Justin A., Fiuzat, Mona, Houston-Miller, Nancy, Januzzi, James L., Leifer, Eric S., Mark, Daniel B., Desvigne-Nickens, Patrice, Paynter, Gayle, Piña, Ileana L., Whellan, David J., O'Connor, Christopher M., Felker, G. Michael, Ahmad, Tariq, Anstrom, Kevin J., Adams, Kirkwood F., Cooper, Lawton S., Ezekowitz, Justin A., Fiuzat, Mona, Houston-Miller, Nancy, Januzzi, James L., Leifer, Eric S., Mark, Daniel B., Desvigne-Nickens, Patrice, Paynter, Gayle, Piña, Ileana L., Whellan, David J., and O'Connor, Christopher M.

Abstract

OBJECTIVES: The GUIDE-IT (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) study is designed to determine the safety, efficacy, and cost-effectiveness of a strategy of adjusting therapy with the goal of achieving and maintaining a target N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of BACKGROUND: Elevations in natriuretic peptide (NP) levels provide key prognostic information in patients with HF. Therapies proven to improve outcomes in patients with HF are generally associated with decreasing levels of NPs, and observational data show that decreases in NP levels over time are associated with favorable outcomes. Results from smaller prospective, randomized studies of this strategy thus far have been mixed, and current guidelines do not recommend serial measurement of NP levels to guide therapy in patients with HF. METHODS: GUIDE-IT is a prospective, randomized, controlled, unblinded, multicenter clinical trial designed to randomize approximately 1,100 high-risk subjects with systolic HF (left ventricular ejection fraction ≤40%) to either usual care (optimized guideline-recommended therapy) or a strategy of adjusting therapy with the goal of achieving and maintaining a target NT-proBNP level of CONCLUSIONS: The GUIDE-IT study is designed to definitively assess the effects of an NP-guided strategy in high-risk patients with systolic HF on clinically relevant endpoints of mortality, hospitalization, quality of life, and medical resource use. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [GUIDE-IT]; NCT01685840).

Published
2014

255. International differences in clinical characteristics, management, and outcomes in acute heart failure patients: better short-term outcomes in patients enrolled in Eastern Europe and Russia in the PROTECT trial.

Author

Mentz, Robert J, Mentz, Robert J, Cotter, Gad, Cleland, John GF, Stevens, Susanna R, Chiswell, Karen, Davison, Beth A, Teerlink, John R, Metra, Marco, Voors, Adriaan A, Grinfeld, Liliana, Ruda, Mikhail, Mareev, Viacheslav, Lotan, Chaim, Bloomfield, Daniel M, Fiuzat, Mona, Givertz, Michael M, Ponikowski, Piotr, Massie, Barry M, O'Connor, Christopher M, Mentz, Robert J, Mentz, Robert J, Cotter, Gad, Cleland, John GF, Stevens, Susanna R, Chiswell, Karen, Davison, Beth A, Teerlink, John R, Metra, Marco, Voors, Adriaan A, Grinfeld, Liliana, Ruda, Mikhail, Mareev, Viacheslav, Lotan, Chaim, Bloomfield, Daniel M, Fiuzat, Mona, Givertz, Michael M, Ponikowski, Piotr, Massie, Barry M, and O'Connor, Christopher M

Abstract

AimsThe implications of geographical variation are unknown following adjustment for hospital length of stay (LOS) in heart failure (HF) trials that included patients whether or not they had systolic dysfunction. We investigated regional differences in an international acute HF trial.Methods and resultsThe PROTECT trial investigated 2033 patients with acute HF and renal dysfunction hospitalized at 173 sites in 17 countries with randomization to rolofylline or placebo. We grouped enrolling countries into six regions. Baseline characteristics, in-hospital management, and outcomes were explored by region. The primary study outcome was 60-day mortality or cardiovascular/renal hospitalization. Secondary outcomes included 180-day mortality. Of 2033 patients, 33% were from Eastern Europe, 19% from Western Europe, 16% from Israel, 15% from North America, 14% from Russia, and 3% from Argentina. Marked differences in baseline characteristics, HF phenotype, in-hospital diuretic and vasodilator strategies, and LOS were observed by region. LOS was shortest in North America and Israel (median 5 days) and longest in Russia (median 15 days). Regional event rates varied significantly. Following multivariable adjustment, region was an independent predictor of the risk of mortality/hospitalization at 60 days, with the lowest risk in Russia (hazard ratio 0.39, 95% confidence interval 0.23-0.64 vs. Western Europe) due to lower rehospitalization; mortality differences were attenuated by 180 days.ConclusionsIn an international HF trial, there were differences in baseline characteristics, treatments, LOS, and rehospitalization amongst regions, but little difference in longer term mortality. Rehospitalization differences exist independent of LOS. This analysis may help inform future trial design and should be externally validated.

Published
2014

256. Noncardiac Comorbidities in Heart Failure With Reduced Versus Preserved Ejection Fraction

Author

Mentz, Robert J., primary, Kelly, Jacob P., additional, von Lueder, Thomas G., additional, Voors, Adriaan A., additional, Lam, Carolyn S.P., additional, Cowie, Martin R., additional, Kjeldsen, Keld, additional, Jankowska, Ewa A., additional, Atar, Dan, additional, Butler, Javed, additional, Fiuzat, Mona, additional, Zannad, Faiez, additional, Pitt, Bertram, additional, and O’Connor, Christopher M., additional

Published
2014
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258. Acute heart failure in elderly patients: worse outcomes and differential utility of standard prognostic variables. Insights from the PROTECT trial

Author

Metra, Marco, primary, Mentz, Robert J., additional, Chiswell, Karen, additional, Bloomfield, Daniel M., additional, Cleland, John G.F., additional, Cotter, Gad, additional, Davison, Beth A., additional, Dittrich, Howard C., additional, Fiuzat, Mona, additional, Givertz, Michael M., additional, Lazzarini, Valentina, additional, Mansoor, George A., additional, Massie, Barry M., additional, Ponikowski, Piotr, additional, Teerlink, John R., additional, Voors, Adriaan A., additional, and O'Connor, Christopher M., additional

Published
2014
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259. The Palliative Care in Heart Failure Trial: Rationale and design

Author

Mentz, Robert J., primary, Tulsky, James A., additional, Granger, Bradi B., additional, Anstrom, Kevin J., additional, Adams, Patricia A., additional, Dodson, Gwen C., additional, Fiuzat, Mona, additional, Johnson, Kimberly S., additional, Patel, Chetan B., additional, Steinhauser, Karen E., additional, Taylor, Donald H., additional, O’Connor, Christopher M., additional, and Rogers, Joseph G., additional

Published
2014
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261. Charting a Roadmap for Heart Failure Biomarker Studies

Author

Ahmad, Tariq, primary, Fiuzat, Mona, additional, Pencina, Michael J., additional, Geller, Nancy L., additional, Zannad, Faiez, additional, Cleland, John G.F., additional, Snider, James V., additional, Blankenberg, Stephan, additional, Adams, Kirkwood F., additional, Redberg, Rita F., additional, Kim, Jae B., additional, Mascette, Alice, additional, Mentz, Robert J., additional, O'Connor, Christopher M., additional, Felker, G. Michael, additional, and Januzzi, James L., additional

Published
2014
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262. Rationale and Design of the GUIDE-IT Study

Author

Felker, G. Michael, primary, Ahmad, Tariq, additional, Anstrom, Kevin J., additional, Adams, Kirkwood F., additional, Cooper, Lawton S., additional, Ezekowitz, Justin A., additional, Fiuzat, Mona, additional, Houston-Miller, Nancy, additional, Januzzi, James L., additional, Leifer, Eric S., additional, Mark, Daniel B., additional, Desvigne-Nickens, Patrice, additional, Paynter, Gayle, additional, Piña, Ileana L., additional, Whellan, David J., additional, and O’Connor, Christopher M., additional

Published
2014
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264. Biomarkers of Myocardial Stress and Fibrosis as Predictors of Mode of Death in Patients With Chronic Heart Failure

Author

Ahmad, Tariq, primary, Fiuzat, Mona, additional, Neely, Benjamin, additional, Neely, Megan L., additional, Pencina, Michael J., additional, Kraus, William E., additional, Zannad, Faiez, additional, Whellan, David J., additional, Donahue, Mark P., additional, Piña, Ileana L., additional, Adams, Kirkwood F., additional, Kitzman, Dalane W., additional, O'Connor, Christopher M., additional, and Felker, G. Michael, additional

Published
2014
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265. International differences in clinical characteristics, management, and outcomes in acute heart failure patients: better short-term outcomes in patients enrolled in Eastern Europe and Russia in the PROTECT trial

Author

Mentz, Robert J., primary, Cotter, Gad, additional, Cleland, John G.F., additional, Stevens, Susanna R., additional, Chiswell, Karen, additional, Davison, Beth A., additional, Teerlink, John R., additional, Metra, Marco, additional, Voors, Adriaan A., additional, Grinfeld, Liliana, additional, Ruda, Mikhail, additional, Mareev, Viacheslav, additional, Lotan, Chaim, additional, Bloomfield, Daniel M., additional, Fiuzat, Mona, additional, Givertz, Michael M., additional, Ponikowski, Piotr, additional, Massie, Barry M., additional, and O'Connor, Christopher M., additional

Published
2014
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268. NT-proBNP Goal Achievement Is Associated With Significant Reverse Remodeling and Improved Clinical Outcomes in HFrEF

Author

Daubert, Melissa A., Adams, Kirkwood, Yow, Eric, Barnhart, Huiman X., Douglas, Pamela S., Rimmer, Susan, Norris, Casey, Cooper, Lawton, Leifer, Eric, Desvigne-Nickens, Patrice, Anstrom, Kevin, Fiuzat, Mona, Ezekowitz, Justin, Mark, Daniel B., O’Connor, Christopher M., Januzzi, James, and Felker, G. Michael

Abstract

This study aims to assess the association between biomarker-guided therapy and left ventricular (LV) remodeling.

Published
2019
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269. Antihyperglycemic Therapies to Treat Patients With Heart Failure and Diabetes Mellitus

Author

Sharma, Abhinav, Cooper, Lauren B., Fiuzat, Mona, Mentz, Robert J., Ferreira, João Pedro, Butler, Javed, Fitchett, David, Moses, Alan Charles, O’Connor, Christopher, and Zannad, Faiez

Abstract

There is increasing recognition of the relationship between diabetes and heart failure (HF). Comorbid diabetes is associated with worse outcomes in patients with HF, and death from HF forms a large burden of mortality among patients with diabetes and atherosclerotic cardiovascular disease. However, there is evidence of harm relating to the risk of HF outcomes from several antihyperglycemic therapies. The absence of well-powered randomized controlled studies has resulted in significant treatment variations in the glycemic management in patients with coexisting diabetes and HF. However, there is emerging evidence from recent clinical trials suggesting that sodium-glucose–co-transporter-2 inhibitors may be used as a therapy to improve HF outcomes. In order to understand the current state of knowledge, we reviewed the evolving evidence of antihyperglycemic therapies and present strategies to optimize these therapies in patients with diabetes and HF. This analysis is based on discussions among scientists, clinical trialists, industry sponsors, and regulatory representatives who attended the 12th Global Cardiovascular Clinical Trialists Forum, Washington, DC, December 1 to 3, 2016.

Published
2018
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270. Biomarker-guided therapies in heart failure: a forum for unified strategies.

Author

Fiuzat, Mona, O'Connor, Christopher M., Gueyffier, Francois, Mascette, Alice M., Geller, Nancy L., Mebazaa, Alexandre, Voors, Adriaan A., Adams, Kirkwood F., Pina, Ileana L., Neyses, Ludwig, Muntendam, Pieter, Felker, G. Michael, Pitt, Bertram, Zannad, Faiez, Bristow, Michael R., Fiuzat, Mona, O'Connor, Christopher M., Gueyffier, Francois, Mascette, Alice M., Geller, Nancy L., Mebazaa, Alexandre, Voors, Adriaan A., Adams, Kirkwood F., Pina, Ileana L., Neyses, Ludwig, Muntendam, Pieter, Felker, G. Michael, Pitt, Bertram, Zannad, Faiez, and Bristow, Michael R.

Abstract

The complexity of standard medical treatment for heart failure is growing, and such therapy typically involves 5 or more different medications. Given these pressures, there is increasing interest in harnessing cardiovascular biomarkers for clinical application to more effectively guide diagnosis, risk stratification, and therapy. It may be possible to realize an era of personalized medicine for heart failure treatment in which therapy is optimized and costs are controlled. The direct mechanistic coupling of biologic processes and therapies achieved in cancer treatment remains elusive in heart failure. Recent clinical trials and meta-analyses of biomarkers in heart failure have produced conflicting evidence. In this article, which comprises a summary of discussions from the Global Cardiovascular Clinical Trialists Forum held in Paris, France, we offer a brief overview of the background and rationale for biomarker testing in heart failure, describe opportunities and challenges from a regulatory perspective, and summarize current positions from government agencies in the United States and European Union.

Published
2013

273. The effects of exercise on cardiovascular biomarkers in patients with chronic heart failure

Author

Ahmad, Tariq, primary, Fiuzat, Mona, additional, Mark, Daniel B., additional, Neely, Ben, additional, Neely, Megan, additional, Kraus, William E., additional, Kitzman, Dalane W., additional, Whellan, David J., additional, Donahue, Mark, additional, Zannad, Faiez, additional, Piña, Ileana L., additional, Adams, Kirkwood, additional, O'Connor, Christopher M., additional, and Felker, G. Michael, additional

Published
2014
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274. Predictors of Postdischarge Outcomes From Information Acquired Shortly After Admission for Acute Heart Failure

Author

Cleland, John G., primary, Chiswell, Karen, additional, Teerlink, John R., additional, Stevens, Susanna, additional, Fiuzat, Mona, additional, Givertz, Michael M., additional, Davison, Beth A., additional, Mansoor, George A., additional, Ponikowski, Piotr, additional, Voors, Adriaan A., additional, Cotter, Gad, additional, Metra, Marco, additional, Massie, Barry M., additional, and O’Connor, Christopher M., additional

Published
2014
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276. Relationship Between Galectin-3 Levels and Mineralocorticoid Receptor Antagonist Use in Heart Failure: Analysis From HF-ACTION

Author

Fiuzat, Mona, primary, Schulte, Phillip J., additional, Felker, Michael, additional, Ahmad, Tariq, additional, Neely, Megan, additional, Adams, Kirkwood F., additional, Donahue, Mark P., additional, Kraus, William E., additional, Piña, Ileana L., additional, Whellan, David J., additional, and O’Connor, Christopher M., additional

Published
2014
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277. Heart rate: a prognostic factor and therapeutic target in chronic heart failure. The distinct roles of drugs with heart rate‐lowering properties

Author

Dobre, Daniela, primary, Borer, Jeffrey S., additional, Fox, Kim, additional, Swedberg, Karl, additional, Adams, Kirkwood F., additional, Cleland, John G.F., additional, Cohen‐Solal, Alain, additional, Gheorghiade, Mihai, additional, Gueyffier, Francois, additional, O'Connor, Christopher M., additional, Fiuzat, Mona, additional, Patak, Athul, additional, Piña, Ileana L., additional, Rosano, Giuseppe, additional, Sabbah, Hani N., additional, Tavazzi, Luigi, additional, and Zannad, Faiez, additional

Published
2013
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278. Soluble ST2 in Ambulatory Patients With Heart Failure

Author

Felker, G. Michael, primary, Fiuzat, Mona, additional, Thompson, Vivian, additional, Shaw, Linda K., additional, Neely, Megan L., additional, Adams, Kirkwood F., additional, Whellan, David J., additional, Donahue, Mark P., additional, Ahmad, Tariq, additional, Kitzman, Dalane W., additional, Piña, Ileana L., additional, Zannad, Faiez, additional, Kraus, William E., additional, and O’Connor, Christopher M., additional

Published
2013
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279. Learning from recent trials and shaping the future of acute heart failure trials

Author

Mentz, Robert J., primary, Felker, Gary Michael, additional, Ahmad, Tariq, additional, Peacock, William Frank, additional, Pitt, Bertram, additional, Fiuzat, Mona, additional, Maggioni, Aldo P., additional, Gheorghiade, Mihai, additional, Ando, Yuki, additional, Pocock, Stuart J., additional, Zannad, Faiez, additional, and O'Connor, Christopher M., additional

Published
2013
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280. The past, present and future of renin–angiotensin aldosterone system inhibition

Author

Mentz, Robert J., primary, Bakris, George L., additional, Waeber, Bernard, additional, McMurray, John J.V., additional, Gheorghiade, Mihai, additional, Ruilope, Luis M., additional, Maggioni, Aldo P., additional, Swedberg, Karl, additional, Piña, Ileana L., additional, Fiuzat, Mona, additional, O'Connor, Christopher M., additional, Zannad, Faiez, additional, and Pitt, Bertram, additional

Published
2013
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281. Biomarker-Guided Therapies in Heart Failure: A Forum for Unified Strategies

Author

Fiuzat, Mona, primary, O’Connor, Christopher M., additional, Gueyffier, Francois, additional, Mascette, Alice M., additional, Geller, Nancy L., additional, Mebazaa, Alexandre, additional, Voors, Adriaan A., additional, Adams, Kirkwood F., additional, Piña, Ileana L., additional, Neyses, Ludwig, additional, Muntendam, Pieter, additional, Felker, G. Michael, additional, Pitt, Bertram, additional, Zannad, Faiez, additional, and Bristow, Michael R., additional

Published
2013
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282. Prevention of Atrial Fibrillation by Bucindolol Is Dependent on the Beta 1 389 Arg/Gly Adrenergic Receptor Polymorphism

Author

Aleong, Ryan G., primary, Sauer, William H., additional, Davis, Gordon, additional, Murphy, Guinevere A., additional, Port, J. David, additional, Anand, Inder S., additional, Fiuzat, Mona, additional, O'Connor, Christopher M., additional, Abraham, William T., additional, Liggett, Stephen B., additional, and Bristow, Michael R., additional

Published
2013
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285. RELATIONSHIP BETWEEN EXERCISE TRAINING AND CHANGES IN BIOMARKERS OF MYOCARDIAL STRESS, INJURY AND INFLAMMATION IN PATIENTS WITH CHRONIC HEART FAILURE

Author

Ahmad, Tariq, primary, Fiuzat, Mona, additional, Neely, Ben, additional, Neely, Megan, additional, Adams, Kirkwood, additional, Whellan, David, additional, Donahue, Mark, additional, Kitzman, Dalane, additional, Pina, Ileana, additional, Zannad, Faiez, additional, Kraus, William, additional, O'Connor, Christopher, additional, and Felker, G. Michael, additional

Published
2013
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286. Response to Exercise Training and Outcomes in Patients With Heart Failure and Diabetes Mellitus: Insights From the HF-ACTION Trial.

Author

Banks, Adam Z., Mentz, Robert J., Stebbins, Amanda, Mikus, Catherine R., Schulte, Phillip J., Fleg, Jerome L., Cooper, Lawton S., Leifer, Eric S., Badenhop, Dalynn T., Keteyian, Steven J., Piña, Ileana L., Kitzman, Dalane W., Fiuzat, Mona, Whellan, David J., Kraus, William E., O'Connor, Christopher M., and O'Connor, Christopher M

Abstract

Background: In HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training), exercise training improved functional capacity in heart failure with reduced ejection fraction (HFrEF). Previous studies have suggested that diabetes mellitus (DM) may be associated with an attenuated response to exercise. We explored whether DM attenuated the improvement in functional capacity with exercise.Methods and Results: HF-ACTION randomized 2331 patients with HFrEF to medical therapy with or without exercise training over a median follow-up of 2.5 years. We examined the interaction between DM and exercise response measured by change in 6-minute walk distance (6MWD) and peak VO2. We also examined outcomes by DM status. In HF-ACTION, 748 (32%) patients had DM. DM patients had lower functional capacity at baseline and had lower exercise volumes at 3 months. There was a significant interaction between DM status and exercise training for change in peak VO2 (interaction P = .02), but not 6MWD. In the exercise arm, DM patients had a smaller mean increase in peak VO2 than non-DM patients (P = .03). There was no interaction between DM and exercise on clinical outcomes. After risk adjustment, DM was associated with increased all-cause mortality/hospitalization (P = .03).Conclusions: In HF-ACTION, DM was associated with lower baseline functional capacity, an attenuated improvement in peak VO2, and increased hospitalizations. [ABSTRACT FROM AUTHOR]

Published
2016
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287. Clinical predictors and outcomes of patients with left ventricular thrombus following ST-segment elevation myocardial infarction.

Author

Garber, Adam, Mentz, Robert, Al-Khalidi, Hussein, Shaw, Linda, Fiuzat, Mona, O'Connor, Christopher, and Velazquez, Eric

Abstract

We aimed to characterize the independent predictors of LVT following STEMI and the association with outcomes. The clinical predictors of left ventricular thrombus (LVT) formation after ST-segment elevation myocardial infarction (STEMI) are not well-defined in the contemporary era. We performed a retrospective analysis of STEMI patients at Duke from 2000 to 2011 who had a transthoracic echocardiogram within 90 days post-STEMI and compared patients with and without LVT (LVT+ vs. LVT−). Univariate Cox proportional hazards regression models of baseline characteristics were examined and significant variables were used in a multivariable model to assess adjusted relationships with LVT. A multivariable Cox PH survival model with covariate adjustments was used for assessment of LVT and long-term mortality. Of all eligible patients, 1734 patients met inclusion criteria and 4.3 % (N = 74) had a LVT. LVT+ patients tended to have a history of heart failure (HF) and higher initial troponin compared to LVT- patients. After adjustment, higher heart rate, non-white race, HF severity, and presence of left anterior descending artery (LAD) disease were independent predictors of LVT. There was a trend toward an association between LVT and increased all-cause mortality (HR 1.36; 95 % CI 0.84-2.21, P = 0.22), however this was not statistically significant. LVT was seen in over 4 % of this contemporary post-STEMI population. Several baseline characteristics were independently associated with LVT: Heart rate, HF severity, LAD disease, and non-white race. Prospective studies are warranted to determine whether anticoagulation in patients at increased risk for LVT improves outcomes. [ABSTRACT FROM AUTHOR]

Published
2016
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288. Lessons learned from a clinical trial: Design, rationale, and insights from The Cardiovascular Improvements with Minute Ventilation-targeted Adaptive Sero-Ventilation (ASV) Therapy in Heart Failure (CAT-HF) Study.

Author

Fiuzat, Mona, Oldenberg, Olaf, Whellan, David J., Woehrle, Holger, Punjabi, Naresh M., Anstrom, Kevin J., Blase, Amy B., Benjafield, Adam V., Lindenfeld, JoAnn, and O'Connor, Christopher M.

Subjects
*HEART failure patients, *HEART failure treatment, *CARDIOVASCULAR diseases, *ARTIFICIAL respiration, *HOSPITAL care, *CLINICAL trials
Abstract

Objective The CAT-HF Study was designed to evaluate the safety and efficacy of minute ventilation-targeted adaptive servo-ventilation (MV-ASV) during sleep in addition to optimized medical therapy (active therapy) versus optimized medical therapy alone (usual care) at 6 months, initiated in patients after hospitalization for acute decompensated heart failure (ADHF). This paper outlines the rationale, design and information learned at the time of study discontinuation. Background Sleep disordered breathing (SDB) is common in heart failure patients and is associated with worse outcomes in this patient population. Based on a belief that MV-ASV was safe in stable HF patients, CAT-HF was designed to examine whether MV-ASV improved outcomes in hospitalized HF patients During the course of CAT-HF, new results from SERVE-HF indicated that ASV therapy may be harmful in patients with left ventricular ejection fractions (LVEF) ≤ 45% and central sleep apnea, a subgroup of patients enrolled in CAT-HF. Methods CAT-HF was a prospective, randomized, controlled, multicenter clinical trial (NCT: 01953874) in HF patients with either reduced or preserved ejection fraction and an Apnea–Hypopnea Index ≥ 15 events per hour randomized to usual care or active treatment in a 1:1 ratio. 215 patients were intended to be randomized following a hospitalization for ADHF. At the time of discontinuation, 126 patients were randomized. The primary endpoint is a global rank composite endpoint of death, CV hospitalizations, and Six minute walk distance (6MWD). Secondary endpoints will include changes in functional parameters, biomarkers, quality of life (QOL), sleep, and breathing. Conclusions The CAT-HF study was designed to assess the efficacy and safety of MV ASV treatment in patients after hospitalization for ADHF, but was stopped early due to safety concerns in HF patients with (LVEF) ≤ 45% and predominant central sleep apnea. [ABSTRACT FROM AUTHOR]

Published
2016
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290. Clinical characteristics, response to exercise training, and outcomes in patients with heart failure and chronic obstructive pulmonary disease: Findings from Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION)

Author

Mentz, Robert J., primary, Schulte, Phillip J., additional, Fleg, Jerome L., additional, Fiuzat, Mona, additional, Kraus, William E., additional, Piña, Ileana L., additional, Keteyian, Steven J., additional, Kitzman, Dalane W., additional, Whellan, David J., additional, Ellis, Stephen J., additional, and O'Connor, Christopher M., additional

Published
2013
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291. Combinatorial Pharmacogenetic Interactions of Bucindolol and β1, α2C Adrenergic Receptor Polymorphisms

Author

O'Connor, Christopher M., primary, Fiuzat, Mona, additional, Carson, Peter E., additional, Anand, Inder S., additional, Plehn, Jonathan F., additional, Gottlieb, Stephen S., additional, Silver, Marc A., additional, Lindenfeld, JoAnn, additional, Miller, Alan B., additional, White, Michel, additional, Walsh, Ryan, additional, Nelson, Penny, additional, Medway, Allen, additional, Davis, Gordon, additional, Robertson, Alastair D., additional, Port, J. David, additional, Carr, James, additional, Murphy, Guinevere A., additional, Lazzeroni, Laura C., additional, Abraham, William T., additional, Liggett, Stephen B., additional, and Bristow, Michael R., additional

Published
2012
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292. Implications of geographical variation on clinical outcomes of cardiovascular trials

Author

Mentz, Robert J., primary, Kaski, Juan-Carlos, additional, Dan, Gheorghe-Andrei, additional, Goldstein, Sidney, additional, Stockbridge, Norman, additional, Alonso-Garcia, Angeles, additional, Ruilope, Luis M., additional, Martinez, Felipe A., additional, Zannad, Faiez, additional, Pitt, Bertram, additional, Fiuzat, Mona, additional, and O'Connor, Christopher M., additional

Published
2012
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295. The PROTECT in‐hospital risk model: 7‐day outcome in patients hospitalized with acute heart failure and renal dysfunction

Author

O'Connor, Christopher M., primary, Mentz, Robert J., additional, Cotter, Gad, additional, Metra, Marco, additional, Cleland, John G., additional, Davison, Beth A., additional, Givertz, Michael M., additional, Mansoor, George A., additional, Ponikowski, Piotr, additional, Teerlink, John R., additional, Voors, Adriaan A., additional, Fiuzat, Mona, additional, Wojdyla, Daniel, additional, Chiswell, Karen, additional, and Massie, Barry M., additional

Published
2012
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298. QUALITY OF LIFE 60 DAYS AFTER AN ACUTE HEART FAILURE EVENT: INSIGHTS FROM THE PROTECT TRIAL

Author

Cleland, John, primary, Chiswell, Karen, additional, Filippatos, Gerasimos, additional, Givertz, Michael, additional, Massie, Barry, additional, Cotter, Gad, additional, Davison, Beth, additional, Fiuzat, Mona, additional, Voors, A.A., additional, Mansoor, George, additional, Ponikowski, Piotr, additional, Teerlink, John, additional, and O'Connor, Christopher, additional

Published
2012
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299. INTERACTION BETWEEN ST2 LEVELS AND EXERCISE TRAINING IN PATIENTS WITH CHRONIC HEART FAILURE: ANALYSIS FROM THE HF-ACTION TRIAL

Author

Ahmad, Tariq, primary, Felker, G. Michael, additional, Fiuzat, Mona, additional, Thompson, Vivian, additional, Shaw, Linda, additional, Adams, Kirkwood, additional, Whellan, David, additional, Donahue, Mark, additional, Kitzman, Dalane, additional, Pina, Ileana, additional, Zannad, Faiez, additional, Kraus, William, additional, and O'Connor, Christopher, additional

Published
2012
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300. CLINICAL CHARACTERISTICS, RESPONSE TO EXERCISE AND OUTCOMES IN HEART FAILURE PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE: FINDINGS FROM HEART FAILURE – A CONTROLLED TRIAL INVESTIGATING OUTCOMES OF EXERCISE TRAINING (HF-ACTION)

Author

Mentz, Robert J., primary, Schulte, Phillip, additional, Kitzman, Dalane, additional, Fiuzat, Mona, additional, Kraus, William, additional, Piña, Ileana L., additional, Keteyian, Steven, additional, Fleg, Jerome, additional, Ellis, Stephen, additional, Whellan, David, additional, and O'Connor, Christopher, additional

Published
2012
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