Effects of Serelaxin in Patients with Acute Heart Failure

J 2019

Effects of Serelaxin in Patients with Acute Heart Failure

METRA, M., J. R. TEERLINK, G. COTTER, B. A. DAVISON, G. M. FELKER et. al.

Basic information

Original name

Effects of Serelaxin in Patients with Acute Heart Failure

Authors

METRA, M. (380 Italy), J. R. TEERLINK (840 United States of America, guarantor), G. COTTER (840 United States of America), B. A. DAVISON (840 United States of America), G. M. FELKER (840 United States of America), G. FILIPPATOS (300 Greece), B. H. GREENBERG (840 United States of America), P. S. PANG (840 United States of America), P. PONIKOWSKI (616 Poland), A. A. VOORS (528 Netherlands), K. F. ADAMS (840 United States of America), S. D. ANKER (276 Germany), A. ARIAS-MENDOZA (484 Mexico), P. AVENDANO (152 Chile), F. BACAL (76 Brazil), M. BOHM (276 Germany), G. BORTMAN (32 Argentina), J. G. F. CLELAND (826 United Kingdom of Great Britain and Northern Ireland), A. COHEN-SOLAL (250 France), M. G. CRESPO-LEIRO (724 Spain), M. DOROBANTU (642 Romania), L. E. ECHEVERRIA (170 Colombia), R. FERRARI (380 Italy), S. GOLAND (376 Israel), E. GONCALVESOVA (703 Slovakia), A. GOUDEV (100 Bulgaria), L. KOBER (208 Denmark), J. LEMA-OSORES (604 Peru), P. D. LEVY (840 United States of America), K. MCDONALD (372 Ireland), P. MANGA (710 South Africa), B. MERKELY (348 Hungary), C. MUELLER (756 Switzerland), B. PIESKE (276 Germany), J. SILVA-CARDOSO (620 Portugal), Jindřich ŠPINAR (203 Czech Republic, belonging to the institution), I. SQUIRE (826 United Kingdom of Great Britain and Northern Ireland), J. STEPINSKA (616 Poland), W. VAN MIEGHEM (56 Belgium), D. VON LEWINSKI (40 Austria), G. WIKSTROM (752 Sweden), M. B. YILMAZ (792 Turkey), N. HAGNER (840 United States of America), T. HOLBRO (840 United States of America), T. A. HUA (840 United States of America), S. V. SABARWAL (840 United States of America), T. SEVERIN (756 Switzerland), P. SZECSODY (756 Switzerland) and C. GIMPELEWICZ (756 Switzerland)

Edition

New England Journal of Medicine, Waltham, Massachussetts Medical Society, 2019, 0028-4793

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 74.699

RIV identification code

RIV/00216224:14110/19:00115694

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1056/NEJMoa1801291

UT WoS

000483203400007

Keywords in English

SUBSEQUENT MORTALITY; RELAX-AHF; HOSPITALIZATION; NESIRITIDE; ADMISSION; ASSOCIATION; INSIGHTS; OUTCOMES; THERAPY; PROTECT

Abstract

V originále

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.

Citovat

METRA, M., J. R. TEERLINK, G. COTTER, B. A. DAVISON, G. M. FELKER, G. FILIPPATOS, B. H. GREENBERG, P. S. PANG, P. PONIKOWSKI, A. A. VOORS, K. F. ADAMS, S. D. ANKER, A. ARIAS-MENDOZA, P. AVENDANO, F. BACAL, M. BOHM, G. BORTMAN, J. G. F. CLELAND, A. COHEN-SOLAL, M. G. CRESPO-LEIRO, M. DOROBANTU, L. E. ECHEVERRIA, R. FERRARI, S. GOLAND, E. GONCALVESOVA, A. GOUDEV, L. KOBER, J. LEMA-OSORES, P. D. LEVY, K. MCDONALD, P. MANGA, B. MERKELY, C. MUELLER, B. PIESKE, J. SILVA-CARDOSO, Jindřich ŠPINAR, I. SQUIRE, J. STEPINSKA, W. VAN MIEGHEM, D. VON LEWINSKI, G. WIKSTROM, M. B. YILMAZ, N. HAGNER, T. HOLBRO, T. A. HUA, S. V. SABARWAL, T. SEVERIN, P. SZECSODY and C. GIMPELEWICZ. Effects of Serelaxin in Patients with Acute Heart Failure. New England Journal of Medicine. Waltham: Massachussetts Medical Society, 2019, vol. 381, No 8, p. 716-726. ISSN 0028-4793. Available from: https://dx.doi.org/10.1056/NEJMoa1801291.

@article{1658337,
   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 AriasandMendoza, A. and Avendano, P. and Bacal, F. and Bohm, M. and Bortman, G. and Cleland, J. G. F. and CohenandSolal, A. and CrespoandLeiro, M. G. and Dorobantu, M. and Echeverria, L. E. and Ferrari, R. and Goland, S. and Goncalvesova, E. and Goudev, A. and Kober, L. and LemaandOsores, J. and Levy, P. D. and McDonald, K. and Manga, P. and Merkely, B. and Mueller, C. and Pieske, B. and SilvaandCardoso, J. and Špinar, Jindřich and Squire, I. and Stepinska, J. and Van Mieghem, W. and von Lewinski, D. and Wikstrom, G. and Yilmaz, M. B. and Hagner, N. and Holbro, T. and Hua, T. A. and Sabarwal, S. V. and Severin, T. and Szecsody, P. and Gimpelewicz, C.},
   article_location = {Waltham},
   article_number = {8},
   doi = {http://dx.doi.org/10.1056/NEJMoa1801291},
   keywords = {SUBSEQUENT MORTALITY; RELAX-AHF; HOSPITALIZATION; NESIRITIDE; ADMISSION; ASSOCIATION; INSIGHTS; OUTCOMES; THERAPY; PROTECT},
   language = {eng},
   issn = {0028-4793},
   journal = {New England Journal of Medicine},
   title = {Effects of Serelaxin in Patients with Acute Heart Failure},
   url = {https://pubmed.ncbi.nlm.nih.gov/31433919/?from_single_result=RELAX-AHF-2+Committees+Investigators%5BCorporate+Author%5D&expanded_search_query=RELAX-AHF-2+Committees+Investigators%5BCorporate+Author%5D},
   volume = {381},
   year = {2019}
}

TY  - JOUR
ID  - 1658337
AU  - 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. - Avendano, P. - Bacal, F. - Bohm, M. - Bortman, G. - Cleland, J. G. F. - Cohen-Solal, A. - Crespo-Leiro, M. G. - Dorobantu, M. - Echeverria, L. E. - Ferrari, R. - Goland, S. - Goncalvesova, E. - Goudev, A. - Kober, L. - Lema-Osores, J. - Levy, P. D. - McDonald, K. - Manga, P. - Merkely, B. - Mueller, C. - Pieske, B. - Silva-Cardoso, J. - Špinar, Jindřich - Squire, I. - Stepinska, J. - Van Mieghem, W. - von Lewinski, D. - Wikstrom, G. - Yilmaz, M. B. - Hagner, N. - Holbro, T. - Hua, T. A. - Sabarwal, S. V. - Severin, T. - Szecsody, P. - Gimpelewicz, C.
PY  - 2019
TI  - Effects of Serelaxin in Patients with Acute Heart Failure
JF  - New England Journal of Medicine
VL  - 381
IS  - 8
SP  - 716-726
EP  - 716-726
PB  - Massachussetts Medical Society
SN  - 00284793
KW  - SUBSEQUENT MORTALITY
KW  - RELAX-AHF
KW  - HOSPITALIZATION
KW  - NESIRITIDE
KW  - ADMISSION
KW  - ASSOCIATION
KW  - INSIGHTS
KW  - OUTCOMES
KW  - THERAPY
KW  - PROTECT
UR  - https://pubmed.ncbi.nlm.nih.gov/31433919/?from_single_result=RELAX-AHF-2+Committees+Investigators%5BCorporate+Author%5D&expanded_search_query=RELAX-AHF-2+Committees+Investigators%5BCorporate+Author%5D
L2  - https://pubmed.ncbi.nlm.nih.gov/31433919/?from_single_result=RELAX-AHF-2+Committees+Investigators%5BCorporate+Author%5D&expanded_search_query=RELAX-AHF-2+Committees+Investigators%5BCorporate+Author%5D
N2  - 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.
ER  -

METRA, M., J. R. TEERLINK, G. COTTER, B. A. DAVISON, G. M. FELKER, G. FILIPPATOS, B. H. GREENBERG, P. S. PANG, P. PONIKOWSKI, A. A. VOORS, K. F. ADAMS, S. D. ANKER, A. ARIAS-MENDOZA, P. AVENDANO, F. BACAL, M. BOHM, G. BORTMAN, J. G. F. CLELAND, A. COHEN-SOLAL, M. G. CRESPO-LEIRO, M. DOROBANTU, L. E. ECHEVERRIA, R. FERRARI, S. GOLAND, E. GONCALVESOVA, A. GOUDEV, L. KOBER, J. LEMA-OSORES, P. D. LEVY, K. MCDONALD, P. MANGA, B. MERKELY, C. MUELLER, B. PIESKE, J. SILVA-CARDOSO, Jindřich ŠPINAR, I. SQUIRE, J. STEPINSKA, W. VAN MIEGHEM, D. VON LEWINSKI, G. WIKSTROM, M. B. YILMAZ, N. HAGNER, T. HOLBRO, T. A. HUA, S. V. SABARWAL, T. SEVERIN, P. SZECSODY and C. GIMPELEWICZ. Effects of Serelaxin in Patients with Acute Heart Failure. \textit{New England Journal of Medicine}. Waltham: Massachussetts Medical Society, 2019, vol.~381, No~8, p.~716-726. ISSN~0028-4793. Available from: https://dx.doi.org/10.1056/NEJMoa1801291.

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