Key result
Early IV serelaxin cuts 180-day mortality ~38% in acute heart failure.
Why the study?
Does intravenous serelaxin improve biomarkers of organ damage and reduce 180-day mortality in patients hospitalized for acute heart failure?
RCT (n=1,395)
Double-blind
randomized
Yes
Does intravenous serelaxin improve biomarkers of organ damage and reduce 180-day mortality in patients hospitalized for acute heart failure?
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Given the relatively small number of deaths in the RELAX-AHF trial (n = 107), it is possible that these differences are due to chance alone and will not be observed in the larger phase III serelaxin trial.”
“Professor Marco Metra, University of Brescia and Civil Hospital, Brescia, Italy, presented results from a post-hoc analysis combining data from RELAX-AHF and Pre RELAX-AHF, a previous Phase II study. This combined analysis of 1,395 patients (59% men) confirmed again that serelaxin improves outcome within 180 days (hazard ratio [HR]: 0.62; 95% confidence interval [CI]: 0.43 -- 0.88; p = 0.0076). Furthermore, serelaxin improved markers of cardiac (high-sensitivity cardiac troponin T), renal (creatinine and cystatin-C) and hepatic function (aspartate transaminase and alanine transaminase) as well as serum levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) at day 2 in the RELAX-AHF study.”
“Recognizing the urgent patient need, today we presented what we believe to be a persuasive picture of the evidence for RLX030 so far — compelling results from our Phase II and III trials with no significant safety concerns.”
Early administration of intravenous serelaxin in acute heart failure is associated with reduced 180-day mortality and improved markers of organ damage and decongestion.
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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Metra et al. (2012) conducted an RCT in acute heart failure (n=1,395). Serelaxin vs. intravenous placebo was evaluated on 180-day all-cause mortality (HR 0.62, 95% CI 0.43 to 0.88, p=0.0076). Early administration of intravenous serelaxin reduced 180-day mortality in patients hospitalized for acute heart failure (HR 0.62; 95% CI 0.43-0.88; p=0.0076).
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