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Clinical Trial
. 2013 Jan 15;61(2):196-206.
doi: 10.1016/j.jacc.2012.11.005.

Effect of serelaxin on cardiac, renal, and hepatic biomarkers in the Relaxin in Acute Heart Failure (RELAX-AHF) development program: correlation with outcomes

Marco Metra  1 , Gad Cotter, Beth A Davison, G Michael Felker, Gerasimos Filippatos, Barry H Greenberg, Piotr Ponikowski, Elaine Unemori, Adriaan A Voors, Kirkwood F Adams Jr, Maria I Dorobantu, Liliana Grinfeld, Guillaume Jondeau, Alon Marmor, Josep Masip, Peter S Pang, Karl Werdan, Margaret F Prescott, Christopher Edwards, Sam L Teichman, Angelo Trapani, Christopher A Bush, Rajnish Saini, Christoph Schumacher, Thomas Severin, John R Teerlink; RELAX-AHF Investigators
Affiliations
Free article
Clinical Trial

Effect of serelaxin on cardiac, renal, and hepatic biomarkers in the Relaxin in Acute Heart Failure (RELAX-AHF) development program: correlation with outcomes

Marco Metra et al. J Am Coll Cardiol. .
Free article

Abstract

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.

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