Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX-AHF-2 study.

Published

Journal Article

Patients admitted for acute heart failure (AHF) experience high rates of in-hospital and post-discharge morbidity and mortality despite current therapies. Serelaxin is recombinant human relaxin-2, a hormone with vasodilatory and end-organ protective effects believed to play a central role in the cardiovascular and renal adaptations of human pregnancy. In the phase 3 RELAX-AHF trial, serelaxin met its primary endpoint of improving dyspnoea through day 5 in patients admitted for AHF. Compared to placebo, serelaxin also reduced worsening heart failure (WHF) by 47% through day 5 and both all-cause and cardiovascular mortality by 37% through day 180. RELAX-AHF-2 ( ClinicalTrials.gov NCT01870778) is designed to confirm serelaxin's effect on these clinical outcomes. RELAX-AHF-2 is a multicentre, randomized, double-blind, placebo-controlled, event-driven, phase 3 trial enrolling ∼6800 patients hospitalized for AHF with dyspnoea, congestion on chest radiograph, increased natriuretic peptide levels, mild-to-moderate renal insufficiency, and systolic blood pressure ≥125 mmHg. Patients are randomized within 16 h of presentation to 48 h intravenous infusions of serelaxin (30 µg/kg/day) or placebo, both in addition to standard of care treatments. The primary objectives are to demonstrate that serelaxin is superior to placebo in reducing: (i) 180 day cardiovascular death, and (ii) occurrence of WHF through day 5. Key secondary endpoints include 180 day all-cause mortality, composite of 180 day combined cardiovascular mortality or heart failure/renal failure rehospitalization, and in-hospital length of stay during index AHF. The results from RELAX-AHF-2 will provide data on the potential beneficial effect of serelaxin on cardiovascular mortality and WHF in selected patients with AHF.

Full Text

Duke Authors

Cited Authors

  • Teerlink, JR; Voors, AA; Ponikowski, P; Pang, PS; Greenberg, BH; Filippatos, G; Felker, GM; Davison, BA; Cotter, G; Gimpelewicz, C; Boer-Martins, L; Wernsing, M; Hua, TA; Severin, T; Metra, M

Published Date

  • June 2017

Published In

Volume / Issue

  • 19 / 6

Start / End Page

  • 800 - 809

PubMed ID

  • 28452195

Pubmed Central ID

  • 28452195

Electronic International Standard Serial Number (EISSN)

  • 1879-0844

Digital Object Identifier (DOI)

  • 10.1002/ejhf.830

Language

  • eng

Conference Location

  • England