G Michael Felker1, John R Teerlink2, Javed Butler3, Adrian F Hernandez4, Alan B Miller5, Gad Cotter6, Beth A Davison6, Gerasimos Filippatos7, Barry H Greenberg8, Piotr Ponikowski9, Adriaan A Voors10, Tsushung A Hua11, Thomas M Severin12, Elaine Unemori13, Marco Metra14. 1. Division of Cardiology, Duke University School of Medicine and Duke Heart Center, Durham, North Carolina. Electronic address: michael.felker@duke.edu. 2. Division of Cardiology, University of California at San Francisco and San Francisco Veterans Affairs Medical Center, San Francisco, California. 3. Division of Cardiology, Emory University, Atlanta, Georgia. 4. Division of Cardiology, Duke University School of Medicine and Duke Heart Center, Durham, North Carolina. 5. Division of Cardiology, University of Florida, Jacksonville, Florida. 6. Momentum Research Inc., Durham, North Carolina. 7. Department of Cardiology, Athens University Hospital, Attikon, Athens, Greece. 8. Division of Cardiology, University of California at San Diego, San Diego, California. 9. Department of Cardiology, Medical University, Clinical Military Hospital, Wroclaw, Poland. 10. Department of Cardiology, Ek, Groningen, the Netherlands. 11. Novartis Pharmaceuticals Corp., East Hanover, New Jersey. 12. Novartis Pharma AG, Basel, Switzerland. 13. Corthera, Inc., San Carlos, California. 14. Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health; University of Brescia, Brescia, Italy.
Abstract
BACKGROUND: Little is known about mode of death after acute heart failure (AHF) hospitalization. In the RELAX-AHF (Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure) study, serelaxin, the recombinant form of human relaxin-2, reduced post-discharge mortality at 180 days in selected patients with AHF. OBJECTIVES: The goal of this study was to assess the effect of serelaxin on specific modes of death in patients with AHF. METHODS: The RELAX-AHF study randomized 1,161 patients with AHF to 48 h of therapy with intravenousserelaxin or placebo. Patients were followed for vital status through 180 days. A blinded clinical events committee reviewed all deaths and adjudicated a cause of death on the basis of pre-specified criteria. Cox proportional hazard models were used to assess the effect of serelaxin on each mode of death, on the basis of pre-specified groupings of mode of death. RESULTS: There were 107 deaths (9.3%): 37 (35%) due to HF, 25 (23%) due to sudden death, 15 (14%) due to other cardiovascular (CV) causes, 19 (18%) due to non-CV causes, and 11 (10%) classified as unknown. The treatment effect of serelaxin was most pronounced on other CV deaths (hazard ratio [HR]: 0.29; 95% CI: 0.12 to 0.73; p = 0.005) and sudden death (HR: 0.46; 95% CI: 0.20 to 1.07; p = 0.065). There was no apparent impact of serelaxin treatment on HF deaths or non-CV deaths. CONCLUSIONS: In the RELAX-AHF study, the effects of serelaxin on mortality were primarily driven by reduction in mortality from other CV causes and sudden death, without apparent impact on HF deaths. (Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure [RELAX-AHF]; NCT00520806).
RCT Entities:
BACKGROUND: Little is known about mode of death after acute heart failure (AHF) hospitalization. In the RELAX-AHF (Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure) study, serelaxin, the recombinant form of humanrelaxin-2, reduced post-discharge mortality at 180 days in selected patients with AHF. OBJECTIVES: The goal of this study was to assess the effect of serelaxin on specific modes of death in patients with AHF. METHODS: The RELAX-AHF study randomized 1,161 patients with AHF to 48 h of therapy with intravenous serelaxin or placebo. Patients were followed for vital status through 180 days. A blinded clinical events committee reviewed all deaths and adjudicated a cause of death on the basis of pre-specified criteria. Cox proportional hazard models were used to assess the effect of serelaxin on each mode of death, on the basis of pre-specified groupings of mode of death. RESULTS: There were 107 deaths (9.3%): 37 (35%) due to HF, 25 (23%) due to sudden death, 15 (14%) due to other cardiovascular (CV) causes, 19 (18%) due to non-CV causes, and 11 (10%) classified as unknown. The treatment effect of serelaxin was most pronounced on other CV deaths (hazard ratio [HR]: 0.29; 95% CI: 0.12 to 0.73; p = 0.005) and sudden death (HR: 0.46; 95% CI: 0.20 to 1.07; p = 0.065). There was no apparent impact of serelaxin treatment on HF deaths or non-CV deaths. CONCLUSIONS: In the RELAX-AHF study, the effects of serelaxin on mortality were primarily driven by reduction in mortality from other CV causes and sudden death, without apparent impact on HF deaths. (Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure [RELAX-AHF]; NCT00520806).
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