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y Effects of Serelaxin in Patients with Acute Heart Failure

Metra, Marco (author)
Univ Brescia, Cardiol, Dept Med & Surg Specialties, Radiol Sci & Publ Hlth, Brescia, Italy
Teerlink, John R. (author)
Univ Calif San Francisco, Sect Cardiol, San Francisco Vet Affairs Med Ctr, San Francisco, CA 94143 USA;Univ Calif San Francisco, Sch Med, San Francisco, CA USA
Cotter, Gad (author)
Duke Univ, Sch Med, Momentum Res, Durham, NC USA
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Davison, Beth A. (author)
Duke Univ, Sch Med, Momentum Res, Durham, NC USA
Felker, G. Michael (author)
Duke Univ, Sch Med, Div Cardiol, Durham, NC USA
Filippatos, Gerasimos (author)
Univ Cyprus, Sch Med, Nicosia, Cyprus;Univ Athens, Sch Med, Athens, Greece
Greenberg, Barry H. (author)
Univ Calif San Diego, Div Cardiol, La Jolla, CA 92093 USA
Pang, Peter S. (author)
Indiana Univ Sch Med, Dept Emergency Med, Indianapolis, IN 46202 USA;Regenstrief Inst Hlth Care, Indianapolis, IN 46202 USA
Ponikowski, Piotr (author)
Med Univ, Mil Hosp, Dept Heart Dis, Wroclaw, Poland
Voors, Adriaan A. (author)
Univ Groningen, Groningen, Netherlands
Adams, Kirkwood F. (author)
Univ N Carolina, Chapel Hill, NC 27515 USA
Anker, Stefan D. (author)
Charite Univ Med Berlin, Partner Site Berlin, Dept Internal Med & Cardiol, Campus Virchow Klinikum,German Ctr Cardiovasc Res, Berlin, Germany;Charite Univ Med Berlin, Berlin Inst Hlth Ctr Regenerat Therapies, Campus Virchow Klinikum, Berlin, Germany
Arias-Mendoza, Alexandra (author)
Inst Nacl Cardiol Ignacio Chavez, Coronary Care & Emergency Dept, Mexico City, DF, Mexico
Avendano, Patricio (author)
Hosp Clin Fuerza Aerea Chile, Las Condes, Chile
Bacal, Fernando (author)
Univ Sao Paulo, Heart Inst InCor, Heart Transplantat Dept, Sao Paulo, Brazil;Hosp Israelita Albert Einstein, Sao Paulo, Brazil
Boehm, Michael (author)
Saarland Univ, Univ Klinikum Saarlandes Homburg, Homburg, Germany
Bortman, Guillermo (author)
Sanat Trinidad Mitre, Buenos Aires, DF, Argentina
Cleland, John G. F. (author)
Univ Glasgow, Robertson Ctr Biostat & Clin Trials, Glasgow, Lanark, Scotland;Imperial Coll, Natl Heart & Lung Inst, London, England
Cohen-Solal, Alain (author)
Hop Lariboisiere, Cardiol Dept, Paris, France;Univ Paris, Paris, France
Crespo-Leiro, Maria G. (author)
Univ A Coruna, Complejo Hosp Univ A Coruna, Ctr Invest Biomed Red Enfermedades Cardiovasc, La Coruna, Spain
Dorobantu, Maria (author)
Carol Davila Univ Med & Pharm, Bucharest, Romania
Echeverria, Luis E. (author)
Fdn Cardiovasc Colombia, Heart Failure & Heart Transplant Clin, Floridablanca, Colombia
Ferrari, Roberto (author)
Univ Ferrara, Ctr Cardiol, Ferrara, Italy;Maria Cecilia Hosp, GVM Care & Res, Cotignola, Italy
Goland, Sorel (author)
Hebrew Univ Jerusalem, Kaplan Med Ctr, Heart Inst, Jerusalem, Israel
Goncalvesova, Eva (author)
Natl Cardiovasc Inst, Bratislava, Slovakia
Goudev, Assen (author)
Med Univ Sofia, Tzaritza Ioanna Univ Hosp, Sofia, Bulgaria
Kober, Lars (author)
Univ Copenhagen, Rigshosp, Dept Cardiol, Copenhagen, Denmark
Lema-Osores, Juan (author)
Hosp Nacl Arzobispo Loayza, Internal Med Cardiol, Internal Med Dept, Lima, Peru
Levy, Phillip D. (author)
Wayne State Univ, Sch Med, Detroit, MI USA;Cardiovasc Res Inst, Detroit, MI USA
McDonald, Kenneth (author)
Univ Coll Dublin, Sch Med & Med Sci, Dublin, Ireland;Univ Coll Dublin, St Vincents Univ Hosp, Dublin, Ireland
Manga, Pravin (author)
Univ Witwatersrand, Dept Internal Med, Johannesburg, South Africa
Merkely, Bela (author)
Semmelweis Univ, Heart & Vasc Ctr, Budapest, Hungary
Mueller, Christian (author)
Univ Basel, Univ Hosp Basel, Dept Cardiol, Basel, Switzerland;Univ Basel, Univ Hosp Basel, Cardiovasc Res Inst Basel, Basel, Switzerland
Pieske, Burkert (author)
Charite Univ Med Berlin, Partner Site Berlin, Dept Internal Med & Cardiol, Campus Virchow Klinikum,German Ctr Cardiovasc Res, Berlin, Germany
Silva-Cardoso, Jose (author)
Univ Porto, Med Sch, Sao Joao Med Ctr, CINTESIS, Porto, Portugal
Spinar, Jindrich (author)
Squire, Iain (author)
Univ Leicester, Dept Cardiovasc Sci, Leicester, Leics, England;Glenfield Hosp, Biomed Res Ctr, Natl Inst Hlth Res, Leicester, Leics, England
Stepinska, Janina (author)
Van Mieghem, Walter (author)
Univ Hasselt, Hasselt, Belgium
von Lewinski, Dirk (author)
Med Univ Graz, Dept Internal Med, Div Cardiol, Graz, Austria
Wikström, Gerhard (author)
Uppsala universitet,Kardiologi
Yilmaz, Mehmet B. (author)
Dokuz Eylul Univ, Dept Cardiol, Fac Med, Izmir, Turkey
Hagner, Nicole (author)
Novartis Pharmaceut, E Hanover, NJ USA
Holbro, Thomas (author)
Novartis Pharmaceut, Basel, Switzerland;Novartis Pharmaceut, E Hanover, NJ USA
Hua, Tsushung A. (author)
Novartis Pharmaceut, E Hanover, NJ USA
Sabarwal, Shalini V. (author)
Novartis Pharmaceut, E Hanover, NJ USA
Severin, Thomas (author)
Novartis Pharmaceut, Basel, Switzerland
Szecsody, Peter (author)
Novartis Pharmaceut, Basel, Switzerland
Gimpelewicz, Claudio (author)
Novartis Pharmaceut, Basel, Switzerland
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 (creator_code:org_t)
MASSACHUSETTS MEDICAL SOC, 2019
2019
English.
In: New England Journal of Medicine. - : MASSACHUSETTS MEDICAL SOC. - 0028-4793 .- 1533-4406. ; 381:8, s. 716-726
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • BackgroundSerelaxin 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. MethodsIn 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 mu g 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.ResultsA 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.ConclusionsIn 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. (Funded by Novartis Pharma; RELAX-AHF-2 ClinicalTrials.gov number, NCT01870778.) In a randomized trial, 6545 patients with acute heart failure were assigned to either serelaxin or placebo in addition to standard care. There were no significant differences between the two groups in the incidence of death from cardiovascular causes at 180 days or worsening heart failure at 5 days.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kardiologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)

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