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Metra, Marco, MD; Cotter, Gad, MD; Davison, Beth A., PhD; Felker, G. Michael, MD, MHS; Filippatos, Gerasimos, MD; Greenberg, Barry H., MD; Ponikowski, Piotr, MD, PhD; Unemori, Elaine, PhD; Voors, Adriaan A., MD, PhD; Adams, Kirkwood F., MD; Dorobantu, Maria I., MD; Grinfeld, Liliana, MD; Jondeau, Guillaume, MD, PhD; Marmor, Alon, MD; Masip, Josep, MD; Pang, Peter S., MD; Werdan, Karl, MD; Prescott, Margaret F., PhD; Edwards, Christopher, BS; Teichman, Sam L., MD; Trapani, Angelo, PhD; Bush, Christopher A., PhD; Saini, Rajnish, MD; Schumacher, Christoph, PhD; Severin, Thomas, MD; Teerlink, John R., MD
Journal of the American College of Cardiology, 01/2013, Letnik: 61, Številka: 2Journal Article
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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