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y Effects of Serela...
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Metra, MarcoUniv Brescia, Cardiol, Dept Med & Surg Specialties, Radiol Sci & Publ Hlth, Brescia, Italy
(author)
y Effects of Serelaxin in Patients with Acute Heart Failure
- Article/chapterEnglish2019
Publisher, publication year, extent ...
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MASSACHUSETTS MEDICAL SOC,2019
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printrdacarrier
Numbers
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LIBRIS-ID:oai:DiVA.org:uu-398855
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-398855URI
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https://doi.org/10.1056/NEJMoa1801291DOI
Supplementary language notes
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Language:English
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Summary in:English
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Classification
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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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 and genre
Added entries (persons, corporate bodies, meetings, titles ...)
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Teerlink, John R.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
(author)
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Cotter, GadDuke Univ, Sch Med, Momentum Res, Durham, NC USA
(author)
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Davison, Beth A.Duke Univ, Sch Med, Momentum Res, Durham, NC USA
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Felker, G. MichaelDuke Univ, Sch Med, Div Cardiol, Durham, NC USA
(author)
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Filippatos, GerasimosUniv Cyprus, Sch Med, Nicosia, Cyprus;Univ Athens, Sch Med, Athens, Greece
(author)
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Greenberg, Barry H.Univ Calif San Diego, Div Cardiol, La Jolla, CA 92093 USA
(author)
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Pang, Peter S.Indiana Univ Sch Med, Dept Emergency Med, Indianapolis, IN 46202 USA;Regenstrief Inst Hlth Care, Indianapolis, IN 46202 USA
(author)
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Ponikowski, PiotrMed Univ, Mil Hosp, Dept Heart Dis, Wroclaw, Poland
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Voors, Adriaan A.Univ Groningen, Groningen, Netherlands
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Adams, Kirkwood F.Univ N Carolina, Chapel Hill, NC 27515 USA
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Anker, Stefan D.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
(author)
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Arias-Mendoza, AlexandraInst Nacl Cardiol Ignacio Chavez, Coronary Care & Emergency Dept, Mexico City, DF, Mexico
(author)
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Avendano, PatricioHosp Clin Fuerza Aerea Chile, Las Condes, Chile
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Bacal, FernandoUniv Sao Paulo, Heart Inst InCor, Heart Transplantat Dept, Sao Paulo, Brazil;Hosp Israelita Albert Einstein, Sao Paulo, Brazil
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Boehm, MichaelSaarland Univ, Univ Klinikum Saarlandes Homburg, Homburg, Germany
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Bortman, GuillermoSanat Trinidad Mitre, Buenos Aires, DF, Argentina
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Cleland, John G. F.Univ Glasgow, Robertson Ctr Biostat & Clin Trials, Glasgow, Lanark, Scotland;Imperial Coll, Natl Heart & Lung Inst, London, England
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Cohen-Solal, AlainHop Lariboisiere, Cardiol Dept, Paris, France;Univ Paris, Paris, France
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Crespo-Leiro, Maria G.Univ A Coruna, Complejo Hosp Univ A Coruna, Ctr Invest Biomed Red Enfermedades Cardiovasc, La Coruna, Spain
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Dorobantu, MariaCarol Davila Univ Med & Pharm, Bucharest, Romania
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Echeverria, Luis E.Fdn Cardiovasc Colombia, Heart Failure & Heart Transplant Clin, Floridablanca, Colombia
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Ferrari, RobertoUniv Ferrara, Ctr Cardiol, Ferrara, Italy;Maria Cecilia Hosp, GVM Care & Res, Cotignola, Italy
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Goland, SorelHebrew Univ Jerusalem, Kaplan Med Ctr, Heart Inst, Jerusalem, Israel
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Goncalvesova, EvaNatl Cardiovasc Inst, Bratislava, Slovakia
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Goudev, AssenMed Univ Sofia, Tzaritza Ioanna Univ Hosp, Sofia, Bulgaria
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Kober, LarsUniv Copenhagen, Rigshosp, Dept Cardiol, Copenhagen, Denmark
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Lema-Osores, JuanHosp Nacl Arzobispo Loayza, Internal Med Cardiol, Internal Med Dept, Lima, Peru
(author)
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Levy, Phillip D.Wayne State Univ, Sch Med, Detroit, MI USA;Cardiovasc Res Inst, Detroit, MI USA
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McDonald, KennethUniv Coll Dublin, Sch Med & Med Sci, Dublin, Ireland;Univ Coll Dublin, St Vincents Univ Hosp, Dublin, Ireland
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Manga, PravinUniv Witwatersrand, Dept Internal Med, Johannesburg, South Africa
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Merkely, BelaSemmelweis Univ, Heart & Vasc Ctr, Budapest, Hungary
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Mueller, ChristianUniv Basel, Univ Hosp Basel, Dept Cardiol, Basel, Switzerland;Univ Basel, Univ Hosp Basel, Cardiovasc Res Inst Basel, Basel, Switzerland
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Pieske, BurkertCharite Univ Med Berlin, Partner Site Berlin, Dept Internal Med & Cardiol, Campus Virchow Klinikum,German Ctr Cardiovasc Res, Berlin, Germany
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Silva-Cardoso, JoseUniv Porto, Med Sch, Sao Joao Med Ctr, CINTESIS, Porto, Portugal
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Spinar, Jindrich
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Squire, IainUniv Leicester, Dept Cardiovasc Sci, Leicester, Leics, England;Glenfield Hosp, Biomed Res Ctr, Natl Inst Hlth Res, Leicester, Leics, England
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Stepinska, Janina
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Van Mieghem, WalterUniv Hasselt, Hasselt, Belgium
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von Lewinski, DirkMed Univ Graz, Dept Internal Med, Div Cardiol, Graz, Austria
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Wikström, GerhardUppsala universitet,Kardiologi(Swepub:uu)gewik021
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Yilmaz, Mehmet B.Dokuz Eylul Univ, Dept Cardiol, Fac Med, Izmir, Turkey
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Hagner, NicoleNovartis Pharmaceut, E Hanover, NJ USA
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Holbro, ThomasNovartis Pharmaceut, Basel, Switzerland;Novartis Pharmaceut, E Hanover, NJ USA
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Hua, Tsushung A.Novartis Pharmaceut, E Hanover, NJ USA
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Sabarwal, Shalini V.Novartis Pharmaceut, E Hanover, NJ USA
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Severin, ThomasNovartis Pharmaceut, Basel, Switzerland
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Szecsody, PeterNovartis Pharmaceut, Basel, Switzerland
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Gimpelewicz, ClaudioNovartis Pharmaceut, Basel, Switzerland
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Univ Brescia, Cardiol, Dept Med & Surg Specialties, Radiol Sci & Publ Hlth, Brescia, ItalyUniv 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
(creator_code:org_t)
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In:New England Journal of Medicine: MASSACHUSETTS MEDICAL SOC381:8, s. 716-7260028-47931533-4406
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Metra, Marco
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Teerlink, John R ...
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Cotter, Gad
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Davison, Beth A.
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Felker, G. Micha ...
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Filippatos, Gera ...
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Greenberg, Barry ...
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Pang, Peter S.
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Ponikowski, Piot ...
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Voors, Adriaan A ...
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Adams, Kirkwood ...
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Anker, Stefan D.
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Arias-Mendoza, A ...
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Avendano, Patric ...
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Bacal, Fernando
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Boehm, Michael
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Bortman, Guiller ...
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Cleland, John G. ...
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Cohen-Solal, Ala ...
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Crespo-Leiro, Ma ...
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Dorobantu, Maria
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Echeverria, Luis ...
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Ferrari, Roberto
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Goland, Sorel
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Goncalvesova, Ev ...
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Goudev, Assen
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Kober, Lars
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Lema-Osores, Jua ...
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Levy, Phillip D.
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McDonald, Kennet ...
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Manga, Pravin
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Merkely, Bela
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Mueller, Christi ...
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Pieske, Burkert
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Silva-Cardoso, J ...
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Spinar, Jindrich
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Squire, Iain
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Stepinska, Janin ...
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Van Mieghem, Wal ...
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von Lewinski, Di ...
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Wikström, Gerhar ...
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Yilmaz, Mehmet B ...
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Hagner, Nicole
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Holbro, Thomas
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Hua, Tsushung A.
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Sabarwal, Shalin ...
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Severin, Thomas
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Szecsody, Peter
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Gimpelewicz, Cla ...
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