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. Effects of serelaxin in patients with acute heart failure
Open accessAbstract
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. (Funded by Novartis Pharma; RELAX-AHF-2 ClinicalTrials.gov number, NCT01870778.).
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“However, the RELAX -AHF phase-III clinical trial failed in achieving the primary end -points of lowering the 6-month total and cardiovascular adverse events, 3”
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Metadata
- Authors
- Metra, M., Teerlink, J. R., Cotter, G., Davison, B. A., Felker, G. M., Filippatos, G., Greenberg, B. H., Pang, P. S., Ponikowski, P., Voors, A. A., Adams, K. F., Anker, S. D., Arias-Mendoza, A., Avendaño, P., Bacal, F., Böhm, M., Bortman, G., Cleland, J. G. F., Cohen-Solal, A., Crespo-Leiro, M. G., Dorobantu, M., Echeverría, L. E., Ferrari, R., Goland, S., Goncalvesová, E., Goudev, A., Køber, L., Lema-Osores, J., Levy, P. D., McDonald, K., Manga, P., Merkely, B., Mueller, C., Pieske, B., Silva-Cardoso, J., Špinar, J., Squire, I., Stępińska, J., Van Mieghem, W., von Lewinski, D., Wikström, G., Yilmaz, M. B., Hagner, N., Holbro, T., Hua, T. A., Sabarwal, S. V., Severin, T., Szecsödy, P., & Gimpelewicz, C.
- Affiliations
- San Francisco VA Medical Center (US)
- University of North Carolina at Chapel Hill (US)
- From Cardiology, Department of Medical and Surgical Specialties, Radiologic Sciences, and Public Health, University of Brescia, Brescia (M.M.), Centro Cardiologico Universitario di Ferrara, University of Ferrara, Ferrara (R.F.), and Maria Cecilia Hospital, GVM Care and Research, Cotignola (R.F.) — all in Italy; the Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Francisco, San Francisco (J.R.T.), and the Division of...
- University of Copenhagen (DK)
- University College Dublin (IE)
- Semmelweis University (HU)
- Uppsala University (SE)
- ORCID
- Metra, Marco
- Teerlink, John R.
- Cotter, Gad
- Davison, Beth A.
- Felker, G. Michael
- Filippatos, Gerasimos
- Greenberg, Barry H.
- Pang, Peter S.
- Ponikowski, Piotr
- Voors, Adriaan A.
- Anker, Stefan D.
- Bacal, Fernando
- Böhm, Michael
- Bortman, Guillermo
- Cleland, John G.F.
- Echeverría, Luis E.
- Ferrari, Roberto
- Goland, Sorel
- Goudev, Assen
- Køber, Lars
- Levy, Phillip D.
- McDonald, Kenneth
- Manga, Pravin
- Merkely, Béla
- Mueller, Christian
- Pieske, Burkert
- Špinar, Jindřich
- Squire, Iain
- Stępińska, Janina
- Wikström, Gerhard
- Gimpelewicz, Claudio
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-08-22
- Volume
- 381
- Issue
- 8
- Pages
- 716-726
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2969766757
- Cited by
- 282
- References
- 32
- Citations by year
- 2026: 25 · 2025: 29 · 2024: 45 · 2023: 42 · 2022: 41 · 2021: 47 · 2020: 38 · 2019: 13
- FWCI
- 25.28
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- New England Journal of Medicine (publishedVersion, other-oa)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
- HAL (submittedVersion)
- University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion, other-oa)
- University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion)
- Document Server@UHasselt (UHasselt) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- Institutional Research Information System (Università degli Studi di Brescia) (submittedVersion, other-oa)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
- Leicester Research Archive (University of Leicester) (submittedVersion, other-oa)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- IUScholarWorks (Indiana University) (submittedVersion)
- Purdue University Indianapolis (Indiana University) (submittedVersion)
- Institutional Research Information System University of Ferrara (University of Ferrara) (submittedVersion, other-oa)
- Funders
- Novartis Pharma AG
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Obstetrics and Gynecology › Pregnancy-related medical research
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Fibrosis and Remodeling
- Keywords
- serelaxin, relaxin-2, acute heart failure, cardiovascular mortality, worsening heart failure, vasodilator therapy, natriuretic peptides, renal failure, dyspnea, hospital readmission, adverse events, heart failure with reduced ejection fraction, heart failure with preserved ejection fraction, length of hospital stay
- MeSH terms
- Acute Disease, Aged, Blood Pressure, Cardiovascular Diseases, Double-Blind Method, Female, Heart Failure, Hospitalization, Humans, Infusions, Intravenous, Male, Recombinant Proteins, Relaxin, Vasodilator Agents, Incidence, Treatment Failure, Disease Progression
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