@article{3105741,
    title = "Effects of serelaxin in patients with acute heart failure",
    author = "Metra, M. and Teerlink, J.R. and Cotter, G. and Davison, B.A. and Felker, G.M. and Filippatos, G. and Greenberg, B.H. and Pang, P.S. and Ponikowski, P. and Voors, A.A. and Adams, K.F. and Anker, S.D. and Arias-Mendoza, A. and Avendaño, P. and Bacal, F. and Böhm, M. and Bortman, G. and Cleland, J.G.F. and Cohen-Solal, A. and Crespo-Leiro, M.G. and Dorobantu, M. and Echeverría, L.E. and Ferrari, R. and Goland, S. and Goncalvesová, E. and Goudev, A. and Køber, L. and Lema-Osores, J. and Levy, P.D. and McDonald, K. and Manga, P. and Merkely, B. and Mueller, C. and Pieske, B. and Silva-Cardoso, J. and Špinar, J. and Squire, I. and Stępińska, J. and Van Mieghem, W. and Von Lewinski, D. and Wikström, G. and Yilmaz, M.B. and Hagner, N. and Holbro, T. and Hua, T.A. and Sabarwal, S.V. and Severin, T. and Szecsödy, P. and Gimpelewicz, C.",
    journal = "The New England journal of medicine",
    year = "2019",
    volume = "381",
    number = "8",
    pages = "716-726",
    publisher = "Massachussetts Medical Society",
    doi = "10.1056/NEJMoa1801291",
    keywords = "natriuretic factor;  placebo;  serelaxin;  recombinant protein;  relaxin;  serelaxin protein, human;  vasodilator agent, acute heart failure;  aged;  Article;  blood pressure measurement;  constipation;  controlled study;  death;  disease severity;  double blind procedure;  drug effect;  dyspnea;  female;  general condition deterioration;  headache;  heart failure;  hospital readmission;  hospitalization;  human;  hypokalemia;  hypotension;  incidence;  kidney failure;  major clinical study;  male;  multicenter study;  muscle spasm;  priority journal;  randomized controlled trial;  systolic blood pressure;  thorax radiography;  urinary tract infection;  acute disease;  blood pressure;  cardiovascular disease;  clinical trial;  disease exacerbation;  drug effect;  heart failure;  intravenous drug administration;  mortality;  pathophysiology;  treatment failure, Acute Disease;  Aged;  Blood Pressure;  Cardiovascular Diseases;  Disease Progression;  Double-Blind Method;  Female;  Heart Failure;  Hospitalization;  Humans;  Incidence;  Infusions, Intravenous;  Male;  Recombinant Proteins;  Relaxin;  Treatment Failure;  Vasodilator Agents",
    abstract = "BACKGROUND Serelaxin is a recombinant form of human relaxin-2, a vasodilator hormone that contributes to cardiovascular and renal adaptations during pregnancy. Previous studies have suggested that treatment with serelaxin may result in relief of symptoms and in better outcomes in patients with acute heart failure. METHODS In this multicenter, double-blind, placebo-controlled, event-driven trial, we enrolled patients who were hospitalized for acute heart failure and had dyspnea, vascular congestion on chest radiography, increased plasma concentrations of natriuretic peptides, mild-to-moderate renal insufficiency, and a systolic blood pressure of at least 125 mm Hg, and we randomly assigned them within 16 hours after presentation to receive either a 48-hour intravenous infusion of serelaxin (30 μg per kilogram of body weight per day) or placebo, in addition to standard care. The two primary end points were death from cardiovascular causes at 180 days and worsening heart failure at 5 days. RESULTS A total of 6545 patients were included in the intention-to-treat analysis. At day 180, death from cardiovascular causes had occurred in 285 of the 3274 patients (8.7%) in the serelaxin group and in 290 of the 3271 patients (8.9%) in the placebo group (hazard ratio, 0.98; 95% confidence interval [CI], 0.83 to 1.15; P=0.77). At day 5, worsening heart failure had occurred in 227 patients (6.9%) in the serelaxin group and in 252 (7.7%) in the placebo group (hazard ratio, 0.89; 95% CI, 0.75 to 1.07; P=0.19). There were no significant differences between the groups in the incidence of death from any cause at 180 days, the incidence of death from cardiovascular causes or rehospitalization for heart failure or renal failure at 180 days, or the length of the index hospital stay. The incidence of adverse events was similar in the two groups. CONCLUSIONS In this trial involving patients who were hospitalized for acute heart failure, an infusion of serelaxin did not result in a lower incidence of death from cardiovascular causes at 180 days or worsening heart failure at 5 days than placebo. Copyright © 2019 Massachusetts Medical Society."
}