Journal
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume 61, Issue 2, Pages 196-206Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2012.11.005
Keywords
congestion; heart failure; organ protection; RELAX-AHF; serelaxin
Categories
Funding
- Corthera, Inc. (a Novartis AG affiliate company)
- Novartis
- Amgen
- Corthera
- Merck
- Roche Diagnostics
- Duke Clinical Research Unit
- Momentum Research
- Medpace
- Otsuka
- Trevena
- BG Medicine
- NHLBI
- Nanosphere
- European Union
- Abbott Vascular
- Bayer
- Abbott
- PDL BioPharma
- Cardio3 Bioscience
- Cytokinetics
- Takeda
- Teva
- Alere
- Cardio3Biosciences
- Celladon
- Ceva
- European Commission
- Dutch Heart Foundation
- Servier
- Torrent
- Vifor
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Objectives The aim of this study was to assess the effects of serelaxin on short-term changes in markers of organ damage and congestion and relate them to 180-day mortality in patients with acute heart failure. Background Hospitalization for acute heart failure is associated with high post-discharge mortality, and this may be related to organ damage. Methods The Pre-RELAX-AHF (Relaxin in Acute Heart Failure) phase II study and RELAX-AHF phase III study were international, multicenter, double-blind, placebo-controlled trials in which patients hospitalized for acute heart failure were randomized within 16 h to intravenous placebo or serelaxin. Each patient was followed daily to day 5 or discharge and at days 5, 14, and 60 after enrollment. Vital status was assessed through 180 days. In RELAX-AHF, laboratory evaluations were performed daily to day 5 and at day 14. Plasma levels of biomarkers were measured at baseline and days 2, 5, and 14. All-cause mortality was assessed as a safety endpoint in both studies. Results Serelaxin reduced 180-day mortality, with similar effects in the phase II and phase III studies (combined studies: N = 1,395; hazard ratio: 0.62; 95% confidence interval: 0.43 to 0.88; p = 0.0076). In RELAX-AHF, changes in markers of cardiac (high-sensitivity cardiac troponin T), renal (creatinine and cystatin-C), and hepatic (aspartate transaminase and alanine transaminase) damage and of decongestion (N-terminal pro-brain natriuretic peptide) at day 2 and worsening heart failure during admission were associated with 180-day mortality. Serelaxin administration improved these markers, consistent with the prevention of organ damage and faster decongestion. Conclusions Early administration of serelaxin was associated with a reduction of 180-day mortality, and this occurred with fewer signs of organ damage and more rapid relief of congestion during the first days after admission. (J Am Coll Cardiol 2013; 61: 196-206) (C) 2013 by the American College of Cardiology Foundation
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