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2,319 results on '"Felker, G"'

1. IL-6 inhibition with clazakizumab in patients receiving maintenance dialysis: a randomized phase 2b trial

Author

Chertow, Glenn M., Chang, Anna Marie, Felker, G. Michael, Heise, Mark, Velkoska, Elena, Fellström, Bengt, Charytan, David M., Clementi, Regina, Gibson, C. Michael, Goodman, Shaun G., Jardine, Meg, Levin, Adeera, Lokhnygina, Yuliya, Mears, Jenny, Mehran, Roxana, Stenvinkel, Peter, Wang, Angela Yee-Moon, Wheeler, David C., Zoccali, Carmine, Ridker, Paul M., Mahaffey, Kenneth W., Tricoci, Pierluigi, and Wolf, Myles

Published
2024
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3. Clinical Profile, Health Care Costs, and Outcomes of Patients Hospitalized for Heart Failure With Severely Reduced Ejection Fraction

Author

Harrington, Josephine, Sun, Jie‐Lena, Fonarow, Gregg C, Heitner, Stephen B, Divanji, Punag H, Binder, Gary, Allen, Larry A, Alhanti, Brooke, Yancy, Clyde W, Albert, Nancy M, DeVore, Adam D, Felker, G Michael, and Greene, Stephen J

Subjects
Cardiovascular, Heart Disease, Clinical Research, Humans, Aged, United States, Stroke Volume, Aftercare, Patient Discharge, Medicare, Heart Failure, Hospitalization, Health Care Costs, costs, ejection fraction, heart failure, outcomes, Cardiorespiratory Medicine and Haematology
Abstract

Background Many patients with heart failure (HF) have severely reduced ejection fraction but do not meet threshold for consideration of advanced therapies (ie, stage D HF). The clinical profile and health care costs associated with these patients in US practice is not well described. Methods and Results We examined patients hospitalized for worsening chronic heart failure with reduced ejection fraction ≤40% from 2014 to 2019 in the GWTG-HF (Get With The Guidelines-Heart Failure) registry, who did not receive advanced HF therapies or have end-stage kidney disease. Patients with severely reduced EF defined as EF ≤30% were compared with those with EF 31% to 40% in terms of clinical profile and guideline-directed medical therapy. Among Medicare beneficiaries, postdischarge outcomes and health care expenditure were compared. Among 113 348 patients with EF ≤40%, 69% (78 589) had an EF ≤30%. Patients with severely reduced EF ≤30% tended to be younger and were more likely to be Black. Patients with EF ≤30% also tended to have fewer comorbidities and were more likely to be prescribed guideline-directed medical therapy ("triple therapy" 28.3% versus 18.2%, P

Published
2023

5. Medication-Attributable Adverse Events in Heart Failure Trials.

Author

Harrington, Josephine, Fonarow, Gregg, Khan, Muhammad, Hernandez, Adrian, Anker, Stefan, Böhm, Michael, Greene, Stephen, Felker, G, Vaduganathan, Muthiah, and Butler, Javed

Subjects
adverse events, guideline-directed medical therapy, heart failure, Humans, Angiotensin Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Heart Failure, Randomized Controlled Trials as Topic, Sodium-Glucose Transporter 2 Inhibitors, Stroke Volume
Abstract

BACKGROUND: Initiation and up-titration of guideline-directed medical therapies (GDMTs) for heart failure with reduced ejection fraction (HFrEF) remains suboptimal, in part because of concerns regarding tolerability and adverse events (AEs). OBJECTIVES: The authors sought to compare rates of AE in patients randomized to GDMT medication vs placebo in a meta-analysis of landmark cardiovascular outcomes trials. METHODS: The authors assessed rates of reported AE in 17 landmark HFrEF clinical trials across each class of GDMT in the placebo and intervention arms. The overall rates of AE for each drug class, the absolute difference in frequency in AEs between the placebo and intervention arms, and the odds of each AE according based on randomization strata were calculated. RESULTS: AE were reported commonly in trials across each class of GDMT, with 75% to 85% of participants reporting at least 1 AE. There was no significant difference in the frequency of AE between the intervention and placebo arms, except for angiotensin-converting enzyme inhibitors (87.0% [95% CI: 85.0%-88.8%] vs 82.0% [95% CI: 79.8%-84.0%], absolute difference: +5% with intervention; P < 0.001). There was no significant difference in drug discontinuation because of AE between placebo and intervention arms in angiotensin-converting enzyme inhibitors, mineralocorticoid receptor antagonists, sodium glucose cotransporter 2 inhibitors, or angiotensin receptor neprilysin inhibitor/angiotensin II receptor blocker trials. Patients randomized to beta-blocker were significantly less likely to stop study drug because of AE than placebo (11.3% [95% CI: 10.3%-12.3%] vs 13.7% [95% CI: 12.5%-14.9%], absolute difference: -1.1%; P = 0.015). When individual types of AE were assessed, the initiation of an intervention vs placebo resulted in small differences in absolute frequency of AE that were largely not statistically significant. CONCLUSIONS: In clinical trials of GDMT for HFrEF, AEs are observed frequently. However, rates of AE are similar between active medication and control, suggesting these may reflect the high risk nature of the heart failure disease state rather than be attributive to a specific therapy.

Published
2023

6. Author Correction: IL-6 inhibition with clazakizumab in patients receiving maintenance dialysis: a randomized phase 2b trial

Author

Chertow, Glenn M., Chang, Anna Marie, Felker, G. Michael, Heise, Mark, Velkoska, Elena, Fellström, Bengt, Charytan, David M., Clementi, Regina, Gibson, C. Michael, Goodman, Shaun G., Jardine, Meg, Levin, Adeera, Lokhnygina, Yuliya, Mears, Jenny, Mehran, Roxana, Stenvinkel, Peter, Wang, Angela Yee-Moon, Wheeler, David C., Zoccali, Carmine, Ridker, Paul M., Mahaffey, Kenneth W., Tricoci, Pierluigi, and Wolf, Myles

Published
2024
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7. Effects of omecamtiv mecarbil in heart failure with reduced ejection fraction according to blood pressure: the GALACTIC-HF trial.

Author

Metra, Marco, Pagnesi, Matteo, Claggett, Brian, Díaz, Rafael, Felker, G, McMurray, John, Solomon, Scott, Bonderman, Diana, Fang, James, Fonseca, Cândida, Goncalvesova, Eva, Howlett, Jonathan, Li, Jing, OMeara, Eileen, Miao, Zi, Abbasi, Siddique, Heitner, Stephen, Kupfer, Stuart, Malik, Fady, and Teerlink, John

Subjects
Cardiovascular outcomes trial, Heart failure, Inotrope, Myotrope, Omecamtiv mecarbil, Humans, Blood Pressure, Stroke Volume, Heart Failure, Ventricular Dysfunction, Left
Abstract

AIM: Patients with heart failure with reduced ejection fraction and low systolic blood pressure (SBP) have high mortality, hospitalizations, and poorly tolerate evidence-based medical treatment. Omecamtiv mecarbil may be particularly helpful in such patients. This study examined its efficacy and tolerability in patients with SBP ≤100 mmHg enrolled in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF). METHODS AND RESULTS: The GALACTIC-HF enrolled patients with baseline SBP ≥85 mmHg with a primary outcome of time to cardiovascular death or first heart failure event. In this analysis, patients were divided according to their baseline SBP (≤100 vs. >100 mmHg). Among the 8232 analysed patients, 1473 (17.9%) had baseline SBP ≤100 mmHg and 6759 (82.1%) had SBP >100 mmHg. The primary outcome occurred in 715 (48.5%) and 2415 (35.7%) patients with SBP ≤100 and >100 mmHg, respectively. Patients with lower SBP were at higher risk of adverse outcomes. Omecamtiv mecarbil, compared with placebo, appeared to be more effective in reducing the primary composite endpoint in patients with SBP ≤100 mmHg [hazard ratio (HR), 0.81; 95% confidence interval (CI), 0.70-0.94] compared with those with SBP >100 mmHg (HR, 0.95; 95% CI, 0.88-1.03; P-value for interaction = 0.051). In both groups, omecamtiv mecarbil did not change SBP values over time and did not increase the risk of adverse events, when compared with placebo. CONCLUSION: In GALACTIC-HF, risk reduction of heart failure outcomes with omecamtiv mecarbil compared with placebo was large and significant in patients with low SBP. Omecamtiv mecarbil did not affect SBP and was well tolerated independent of SBP values.

Published
2022

9. Cardiac Troponin and Treatment Effects of Omecamtiv Mecarbil: Results From the GALACTIC-HF Study

Author

Felker, G. Michael, Solomon, Scott D., Metra, Marco, Mcmurray, John J.V., Diaz, Rafael, Claggett, Brian, Lanfear, David E., Vandekerckhove, Hans, Biering-Sørensen, Tor, Lopes, Renato D., Arias-Mendoza, Alexandra, Momomura, Shin-Ichi, Corbalan, Ramon, Ramires, Felix J.A., Zannad, Faiez, Heitner, Stephen B., Divanji, Punag H., Kupfer, Stuart, Malik, Fady I., and Teerlink, John R.

Published
2024
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11. Frailty, Guideline-Directed Medical Therapy, and Outcomes in HFrEF: From the GUIDE-IT Trial.

Author

Anker, Stefan, Felker, G, Januzzi, James, Butler, Javed, Pandey, Ambarish, Khan, Muhammad, Segar, Matthew, Usman, Muhammad, Singh, Sumitabh, Greene, Stephen, and Fonarow, Gregg

Subjects
frailty, guideline-directed medical therapy, heart failure with reduced ejection fraction, mortality, Angiotensin-Converting Enzyme Inhibitors, Frailty, Heart Failure, Humans, Mineralocorticoid Receptor Antagonists, Stroke Volume
Abstract

OBJECTIVES: In this study, we sought to evaluate the association of frailty with the use of optimal guideline-directed medical therapy (GDMT) and outcomes in heart failure with reduced ejection fraction (HFrEF). BACKGROUND: The burden of frailty in HFrEF is high, and the patterns of GDMT use according to frailty status have not been studied previously. METHODS: A post hoc analysis of patients with HFrEF enrolled in the GUIDE-IT (Guiding Evidence-Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial was conducted. Frailty was assessed with the use of a frailty index (FI) using a 38-variable deficit model, and participants were categorized into 3 groups: class 1: nonfrail, FI 0.31). Multivariate-adjusted Cox models were used to study the association of frailty status with clinical outcomes. Use of optimal GDMT over time (beta-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and mineralocorticoid receptor antagonists) across frailty strata was assessed with the use of adjusted linear and logistic mixed-effect models. RESULTS: The study included 879 participants, of which 56.3% had high frailty burden (class 3 FI). A higher frailty burden was associated with a significantly higher risk of HF hospitalization or death in adjusted Cox models: high frailty vs nonfrail HR: 1.76, 95% CI: 1.20-2.58. On follow-up, participants with high frailty burden also had a significantly lower likelihood of achieving optimal GDMT: high frailty vs non-frail GDMT triple therapy use at study end: 17.7% vs 28.4%; P interaction, frailty class × time

Published
2022

12. Worsening renal function in acute heart failure in the context of diuretic response

Author

Emmens, Johanna E, Maaten, Jozine M, Matsue, Yuya, Figarska, Sylwia M, Sama, Iziah E, Cotter, Gad, Cleland, John GF, Davison, Beth A, Felker, G Michael, Givertz, Michael M, Greenberg, Barry, Pang, Peter S, Severin, Thomas, Gimpelewicz, Claudio, Metra, Marco, Voors, Adriaan A, and Teerlink, John R

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Kidney Disease, Clinical Research, Cardiovascular, Heart Disease, Acute Disease, Diuretics, Heart Failure, Humans, Kidney, Stroke Volume, Ventricular Function, Left, Acute heart failure, Worsening renal function, Diuretic response, Decongestion, Outcomes, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

BackgroundFor patients with acute heart failure (AHF), substantial diuresis after administration of loop diuretics is generally associated with better clinical outcomes but may cause creatinine to rise, suggesting renal function decline. We investigated the interaction between diuretic response and worsening renal function (WRF) on clinical outcomes in patients with AHF.Methods and resultsIn two AHF cohorts (PROTECT, n = 1698 and RELAX-AHF-2, n = 5586 in current analysis), the prognostic impact of WRF (creatinine ≥0.3 mg/dl increase baseline-day 4; sensitivity analyses incorporated baseline renal function) by diuretic response (kg weight loss/40 mg furosemide equivalent baseline-day 4) was investigated with regard to (cardiovascular) death or cardiovascular/renal hospitalization using subpopulation treatment effect pattern plots (STEPP) and survival analyses. WRF occurred in 286 (16.8%) and 1031 (18.5%) patients in PROTECT and RELAX-AHF-2, respectively. Patients with WRF had higher left ventricular ejection fraction and lower estimated glomerular filtration rate at baseline (p

Published
2022

15. Comparing Analytical Methods for Composite End Points in Clinical Trials: Insights from the Vericiguat Global Study in Subjects with Heart Failure With Reduced Ejection Fraction Trial

Author

WESTERHOUT, CYNTHIA M., RATHWELL, SARAH, ANSTROM, KEVIN J., HERNANDEZ, ADRIAN F., PONIKOWSKI, PIOTR, EZEKOWITZ, JUSTIN A., VOORS, ADRIAAN A., FELKER, G. MICHAEL, BAKAL, JEFFREY A., BLAUSTEIN, ROBERT O., NKULIKIYINKA, RICHARD, O'CONNOR, CHRISTOPHER M., and ARMSTRONG, PAUL W.

Published
2024
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16. The Effect of Omecamtiv Mecarbil in Hospitalized Patients as Compared With Outpatients With HFrEF: An Analysis of GALACTIC-HF

Author

DOCHERTY, KIERAN F., MCMURRAY, JOHN J.V., DIAZ, RAFAEL, FELKER, G. MICHAEL, METRA, MARCO, SOLOMON, SCOTT D., ADAMS, KIRKWOOD F., BÖHM, MICHAEL, BRINKLEY, DOUGLAS MARSHALL, ECHEVERRIA, LUIS E., GOUDEV, ASSEN R., HOWLETT, JONATHAN G., LUND, MAYANNA, PONIKOWSKI, PIOTR, YILMAZ, MEHMET B., ZANNAD, FAIEZ, CLAGGETT, BRIAN L., MIAO, ZI MICHAEL, ABBASI, SIDDIQUE A., DIVANJI, PUNAG, HEITNER, STEPHEN B., KUPFER, STUART, MALIK, FADY I., and TEERLINK, JOHN R.

Published
2024
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17. Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial

Author

Wilkoff, Bruce L, Filippatos, Gerasimos, Leclercq, Christophe, Gold, Michael R, Hersi, Ahmad S, Kusano, Kengo, Mullens, Wilfried, Felker, G Michael, Kantipudi, Charan, El-Chami, Mikhael F, Essebag, Vidal, Pierre, Bertrand, Philippon, Francois, Perez-Gil, Francisco, Chung, Eugene S, Sotomonte, Juan, Tung, Stanley, Singh, Balbir, Bozorgnia, Babak, Goel, Satish, Ebert, Hans Holger, Varma, Niraj, Quan, Kara J, Salerno, Fiorella, Gerritse, Bart, van Wel, Janelle, Schaber, Daniel E, Fagan, Dedra H, and Birnie, David

Published
2023
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18. Serum Proteomic Analysis of Peripartum Cardiomyopathy Reveals Distinctive Dysregulation of Inflammatory and Cholesterol Metabolism Pathways

Author

aaaMcNamara, Dennis M., Fett, James D., Pisarcik, Jessica, McTiernan, Charles, Hanley-Yanez, Karen, Gorcsan, John, III, Schelbert, Erik, Alharethi, Rami, Rasmusson, Kismet, Brunisholz, Kim, Butler, Amy, Budge, Deborah, Kfoury, A.G., Horne, Benjamin, Tuinei, Joe, Brown, Heather, Damp, Julie, Naftilan, Allen J., Russell, Jill, Freehardt, Darla, Hsich, Eileen, Oblak, Cynthia, Ewald, Greg, Whitehead, Donna, Flanagan, Jean, Platts, Anne, Elkayam, Uri, Caro, Jorge, Mullin, Stephanie, Givertz, Michael M., Anello, M. Susan, Rajagopalan, Navin, Booth, David, Sandlin, Tiffany, Wijesiri, Wendy, Cooper, Leslie T., Blauwet, Lori A., Brunner, Joann, Phelps, Mary, Kempf, Ruth, Modi, Kalgi, Norwood, Tracy, Briller, Joan, Griza, Decebal Sorin, Felker, G. Michael, Kociol, Robb, Adams, Patricia, Wells, Gretchen, Thohan, Vinay, Wesley-Farrington, Deborah, Soots, Sandra, Sheppard, Richard, Michel, Caroline, Lapointe, Nathalie, Nathaniel, Heather, Kealey, Angela, Semigran, Marc, Daher, Maureen, Boehmer, John, Silber, David, Popjes, Eric, Frey, Patricia, Nicklas, Todd, Alexis, Jeffrey, Caufield, Lori, Thornton, John W., III, Gentry, Mindy, Robinson, Vincent J.B., Sharma, Gyanendra K., Holloway, Joan, Powell, Maria, Markham, David, Drazner, Mark, Fernandez, Lynn, Zucker, Mark, Baran, David A., Gimovsky, Martin L., Hochbaum, Natalia, Patel, Bharati, Adams, Laura, Ramani, Gautam, Gottlieb, Stephen, Robinson, Shawn, Fisher, Stacy, Marshall, Joanne, Haythe, Jennifer, Mancini, Donna, Bijou, Rachel, Farr, Maryjane, Marks, Marybeth, Arango, Henry, Bozkurt, Biykem, Bolos, Mariana, Mather, Paul, Rubin, Sharon, Bonita, Raphael, Eberwine, Susan, Skopicki, Hal, Stergiopoulos, Kathleen, McCathy-Santoro, Ellen, Intravaia, Jennifer, Maas, Elizabeth, Safirstein, Jordan, Kleet, Audrey, Martinez, Nancy, Corpoin, Christine, Hesari, Donna, Chaparro, Sandra, Hudson, Laura J., Ghali, Jalal K., Injic, Zora, Wittstein, Ilan S., McNamara, Dennis M., Janosko, Karen, London, Barry, Gorcsan, John, Tanaka, Hidekazu, Suffoletto, Mathew, Starling, Randall C., McNallan, Annette, Koenig, LuAnne, Pierson, Natalie, Bell, Yanique, Ervin, Alicia, Schrack, Janice, LaDuke, Pam, Torre-Amione, Guillermo, Arredondo, Jeannie, Pauly, Daniel F., Smith, Pamela C., Fuoco, Stephanie, Breton, Elayne, Wesley, Deborah, Dec, G. William, Cocca-Spofford, Diane, Markham, David W., Debes, Colleen, Zucker, Mark J., Liu, Peter, Renton, Judith, Narula, Jagat, Allen, Byron, Westberg, Elizabeth, Lovell, Jana P., Bermea, Kevin, Yu, Jinsheng, Rousseau, Sylvie, Cohen, Charles D., Bhalodia, Aashik, Zita, Marcelle Dina, Head, Richard D., Blumenthal, Roger S., Sharma, Garima, and Adamo, Luigi

Published
2023
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21. Comparative Effectiveness of Primary Prevention Implantable Cardioverter‐Defibrillators in Older Heart Failure Patients With Diabetes Mellitus

Author

Sharma, Abhinav, Wu, Jingjing, Xu, Haolin, Hernandez, Adrian, Felker, G Michael, Al‐Khatib, Sana, Green, Jennifer, Matsouaka, Roland, Fonarow, Gregg C, Singh, Jagmeet P, Heidenreich, Paul A, Ezekowitz, Justin A, and DeVore, Adam

Subjects
Heart Disease, Health Services, Prevention, Aging, Diabetes, Cardiovascular, Comparative Effectiveness Research, Clinical Research, Metabolic and endocrine, Good Health and Well Being, Age Factors, Aged, Aged, 80 and over, Centers for Medicare and Medicaid Services, U.S., Death, Sudden, Cardiac, Defibrillators, Implantable, Diabetes Mellitus, Electric Countershock, Female, Heart Failure, Humans, Male, Primary Prevention, Registries, Risk Assessment, Risk Factors, Stroke Volume, Time Factors, Treatment Outcome, United States, Ventricular Function, Left, arrhythmia, diabetes mellitus, implantable cardioverter-defibrillator, sudden cardiac death, implantable cardioverter‐defibrillator, Cardiorespiratory Medicine and Haematology
Abstract

Background There are conflicting data regarding the benefit of primary prevention implantable cardioverter-defibrillators (ICDs) in patients with diabetes mellitus and heart failure (HF) with reduced ejection fraction. We aimed to assess the comparative effectiveness of ICD placement in patients with diabetes mellitus and HF with reduced ejection fraction. Methods and Results Data were obtained from the Get With the Guidelines-Health Failure registry, linked with claims from the Centers for Medicare & Medicaid Services. We used a Cox proportional hazards model censored at 5 years with propensity score matching. Of the 17 186 patients with HF with reduced ejection fraction from the Centers for Medicare & Medicaid Services claims database (6540 with diabetes mellitus; 38%), 1677 (646 with diabetes mellitus; 39%) received an ICD during their index HF hospitalization or were prescribed an ICD at discharge. Patients with diabetes mellitus and an ICD (n=646), as compared with those without an ICD (n=1031), were more likely to be younger (74 versus 78 years of age) and have coronary artery disease (68% versus 60%). After propensity matching, ICD use among patients with diabetes mellitus, as compared with those without an ICD, was associated with a reduced risk of all-cause mortality at 5 years after HF discharge (54% versus 59%; multivariable hazard ratio, 0.73; 95% CI, 0.64-0.82; P

Published
2020

23. Natriuretic Peptides: Role in the Diagnosis and Management of Heart Failure: A Scientific Statement From the Heart Failure Association of the European Society of Cardiology, Heart Failure Society of America and Japanese Heart Failure Society

Author

Tsutsui, HIROYUKI, ALBERT, NANCY M., COATS, ANDREW J.S., ANKER, STEFAN D., BAYES-GENIS, ANTONI, BUTLER, JAVED, CHIONCEL, OVIDIU, DEFILIPPI, CHRISTOPHER R., DRAZNER, MARK H., FELKER, G. MICHAEL, FILIPPATOS, GERASIMOS, FIUZAT, MONA, IDE, TOMOMI, JANUZZI, JAMES L., Jr, KINUGAWA, KOICHIRO, KUWAHARA, KOICHIRO, MATSUE, YUYA, MENTZ, ROBERT J., METRA, MARCO, PANDEY, AMBARISH, ROSANO, GIUSEPPE, SAITO, YOSHIHIKO, SAKATA, YASUSHI, SATO, NAOKI, SEFEROVIC, PETAR M., TEERLINK, JOHN, YAMAMOTO, KAZUHIRO, and YOSHIMURA, MICHIHIRO

Published
2023
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28. Rhythm Control Versus Rate Control in Patients With Atrial Fibrillation and Heart Failure With Preserved Ejection Fraction: Insights From Get With The Guidelines—Heart Failure

Author

Kelly, Jacob P, DeVore, Adam D, Wu, JingJing, Hammill, Bradley G, Sharma, Abhinav, Cooper, Lauren B, Felker, G Michael, Piccini, Jonathan P, Allen, Larry A, Heidenreich, Paul A, Peterson, Eric D, Yancy, Clyde W, Fonarow, Gregg C, and Hernandez, Adrian F

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Heart Disease, Cardiovascular, Aging, Clinical Research, Aged, Aged, 80 and over, Atrial Fibrillation, Female, Heart Failure, Heart Rate, Humans, Male, Practice Guidelines as Topic, Retrospective Studies, Stroke Volume, atrial fibrillation, heart failure with preserved ejection fraction, rate control, rhythm control, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

Background Limited data exist to guide treatment for patients with heart failure with preserved ejection fraction and atrial fibrillation, including the important decision regarding rate versus rhythm control. Methods and Results We analyzed the Get With The Guidelines-Heart Failure (GWTG-HF) registry linked to Medicare claims data from 2008 to 2014 to describe current treatments for rate versus rhythm control and subsequent outcomes in patients with heart failure with preserved ejection fraction and atrial fibrillation using inverse probability weighted analysis. Rhythm control was defined as use of an antiarrhythmic medication, cardioversion, or AF ablation or surgery. Rate control was defined as use of any combination of β-blocker, calcium channel blocker, and digoxin without evidence of rhythm control. Among 15 682 fee-for-service Medicare patients, at the time of discharge, 1857 were treated with rhythm control and 13 825 with rate control, with minimal differences in baseline characteristics between groups. There was higher all-cause death at 1 year in the rate control compared with the rhythm control group (37.5% and 30.8%, respectively, P

Published
2019

29. Hepatorenal dysfunction identifies high‐risk patients with acute heart failure: insights from the RELAX‐AHF trial

Author

Biegus, Jan, Demissei, Biniyam, Postmus, Douwe, Cotter, Gad, Davison, Beth A, Felker, G Michael, Filippatos, Gerasimos, Gimpelewicz, Claudio, Greenberg, Barry, Metra, Marco, Severin, Thomas, Teerlink, John R, Voors, Adriaan A, and Ponikowski, Piotr

Subjects
Cardiovascular, Acute Disease, Aged, Aged, 80 and over, Bilirubin, Creatinine, Female, Heart Failure, Humans, Kidney Diseases, Liver Diseases, Male, Middle Aged, Prognosis, Severity of Illness Index, Acute heart failure, Liver dysfunction, Kidney dysfunction, MELD-XI score, Cardiorespiratory Medicine and Haematology
Abstract

AimsEpisodes of acute heart failure (AHF) may lead to end-organ dysfunction. In this post hoc analysis of the Relaxin in Acute Heart Failure trial, we used the MELD-XI (Model of End-Stage Liver Dysfunction) score to examine hepatorenal dysfunction in patients with AHF.Methods and resultsOn admission, the MELD-XI score was elevated (abnormal) in 918 (82%) patients, with 638 (57%) having isolated renal dysfunction (creatinine > 1 mg/dL), 73 (6.5%) isolated liver dysfunction (bilirubin > 1 mg/dL), and 207 (18.5%) coexisting dysfunction of the kidneys and the liver (both creatinine and bilirubin > 1 mg/dL). The percentage of patients with elevated MELD-XI score remained constant through a 60 day follow-up, as we observed a gradual decrease of liver dysfunction prevalence, counterbalanced by an increase in renal dysfunction. Serelaxin treatment was associated with a lower MELD-XI score on Day 2 and Day 5 (both P

Published
2019

30. Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel

Author

Psotka, Mitchell A., Abraham, William T., Fiuzat, Mona, Filippatos, Gerasimos, Lindenfeld, JoAnn, Ahmad, Tariq, Felker, G. Michael, Jacob, Richard, Kitzman, Dalane W., Leifer, Eric S., Lewis, Eldrin F., Mentz, Robert J., Nkulikiyinka, Richard, Ni, Wei, Schaber, Daniel E., Sharma, Abhinav, Solomon, Scott D., Stockbridge, Norman, Teerlink, John R., Unger, Ellis F., Whellan, David J., Wittes, Janet, Anker, Stefan D., and O’Connor, Christopher M.

Published
2022
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37. Centrally adjudicated vs. investigator-reported outcomes in randomized heart failure trials.

Author

Wandel, Simon, Desai, Akshay S, Chen, Chien-Wei, McMurray, John J V, Packer, Milton, Solomon, Scott D, Pfeffer, Marc A, Felker, G Michael, Zannad, Faiez, Petrie, Mark C, Jhund, Pardeep S, Attari, Zenab, Mueller-Velten, Guenther, Lefkowitz, Martin, Soergel, David, and Gimpelewicz, Claudio

Subjects
HEART failure, CARDIOVASCULAR disease related mortality, MORTALITY, DEATH rate, TREATMENT effectiveness
Abstract

Background and Aims Heart failure endpoints in cardiovascular outcome trials are commonly identified through centralized adjudication of investigator-reported events. It remains unclear whether central adjudication improves the accuracy of treatment effect estimates in terms of log[hazard ratios (HR)]. Methods Data from seven cardiovascular outcome trials with >1000 patients that included centrally adjudicated heart failure outcomes were utilized to assess (i) the concordance between investigator-reported and centrally adjudicated heart failure and cardiovascular death events; (ii) rates of subsequent all-cause mortality following positively vs. negatively adjudicated heart failure events; and (iii) the correlation of log(HR) based on centrally adjudicated vs. investigator-reported events. Results Positive adjudication rates for investigator-reported events varied widely across trials, but were generally higher for cardiovascular death (range: 87.9%–99.2%) than for heart failure hospitalization (range: 61.6%–88.0%). The risk for subsequent all-cause death was similar for positively and negatively adjudicated heart failure hospitalizations. Log(HR) correlated well for cardiovascular death [ R 2 =.80, 95% credible interval (CrI): 0.53–0.93] and the composite of cardiovascular death or heart failure hospitalization (R 2 =.79, 95% CrI: 0.46–0.93), but less for heart failure hospitalization (R 2 =.57, 95% CrI: 0.10–0.83). Conclusions Positive adjudication rates were lower for heart failure events than cardiovascular death, but even negatively adjudicated heart failure events are prognostically important. Central adjudication of events did not alter the results (precision or estimated log(HR)), though some variation was observed, depending on the indication. The results suggest that the decision to pursue centralized adjudication of heart failure events in a specific trial may need to be individualized. [ABSTRACT FROM AUTHOR]

Published
2024
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40. Assessing race and ethnicity differences in outcomes based on GDMT and target NT-proBNP in patients with heart failure with reduced ejection fraction: An analysis of the GUIDE-IT study

Author

Pahuja, Mohit, Leifer, Eric S., Clarke, John-Ross D., Ahmad, Tariq, Daubert, Melissa A., Mark, Daniel B., Cooper, Lawton, Desvigne-Nickens, Patrice, Fiuzat, Mona, Adams, Kirkwood, Ezekowitz, Justin, Whellan, David J., Januzzi, James L., O'Connor, Christopher M., Felker, G. Michael, and Piña, Ileana L.

Published
2022
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43. Sacubitril/valsartan and cardiovascular biomarkers among patients with recent COVID‐19 infection: The PARACOR‐19 randomized clinical trial

Author

Greene, Stephen J., primary, Chambers, RaKavius, additional, Lerman, Joseph B., additional, Harrington, Josephine, additional, deFilippi, Christopher R, additional, Wendell, David C., additional, Kim, Han W., additional, Green, Cynthia L., additional, Butler, Javed, additional, and Felker, G. Michael, additional

Published
2024
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45. The Impact of Depression on Outcomes in Patients With Heart Failure and Reduced Ejection Fraction Treated in the GUIDE-IT Trial

Author

CHOUAIRI, FOUAD, FUERY, MICHAEL A., MULLAN, CLANCY W., CARABALLO, CESAR, SEN, SOUNOK, MAULION, CHRISTOPHER, WILKINSON, SAMUEL T., SURTI, TORAL, MCCULLOUGH, MEGAN, MILLER, P. ELLIOTT, PACOR, JUSTIN, LEIFER, ERIC S., FELKER, G. MICHAEL, VELAZQUEZ, ERIC J., FIUZAT, MONA, O'CONNOR, CHRISTOPHER M., JANUZZI, JAMES L, DESAI, NIHAR R., and AHMAD, TARIQ

Published
2021
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48. Effect of Ejection Fraction on Clinical Outcomes in Patients Treated With Omecamtiv Mecarbil in GALACTIC-HF

Author

Teerlink, John R., Diaz, Rafael, Felker, G. Michael, McMurray, John J.V., Metra, Marco, Solomon, Scott D., Biering-Sørensen, Tor, Böhm, Michael, Bonderman, Diana, Fang, James C., Lanfear, David E., Lund, Mayanna, Momomura, Shin-ichi, O'Meara, Eileen, Ponikowski, Piotr, Spinar, Jindrich, Flores-Arredondo, Jose H., Claggett, Brian L., Heitner, Stephen B., Kupfer, Stuart, Abbasi, Siddique A., and Malik, Fady I.

Published
2021
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49. Intercountry Differences in Guideline-Directed Medical Therapy and Outcomes Among Patients With Heart Failure

Author

Fuery, Michael A., Chouairi, Fouad, Januzzi, James L., Moe, Gordon W., Caraballo, Cesar, McCullough, Megan, Miller, P. Elliott, Reinhardt, Samuel W., Clark, Katherine, Oseran, Andrew, Milner, Aidan, Pacor, Justin, Kahn, Peter A., Singh, Avinainder, Ravindra, Neal, Guha, Avirup, Vadlamani, Lina, Kulkarni, Neeti S., Fiuzat, Mona, Felker, G. Michael, O’Connor, Christopher M., Ahmad, Tariq, Ezekowitz, Justin, and Desai, Nihar R.

Published
2021
Full Text
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