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Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure
JR. Teerlink, R. Diaz, GM. Felker, JJV. McMurray, M. Metra, SD. Solomon, KF. Adams, I. Anand, A. Arias-Mendoza, T. Biering-Sørensen, M. Böhm, D. Bonderman, JGF. Cleland, R. Corbalan, MG. Crespo-Leiro, U. Dahlström, LE. Echeverria, JC. Fang, G....
Language English Country United States
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 1980-01-03 to 3 months ago
Nursing & Allied Health Database (ProQuest)
from 1980-01-03 to 3 months ago
Health & Medicine (ProQuest)
from 1980-01-03 to 3 months ago
Family Health Database (ProQuest)
from 1980-01-03 to 3 months ago
Psychology Database (ProQuest)
from 1980-01-03 to 3 months ago
Health Management Database (ProQuest)
from 1980-01-03 to 3 months ago
Public Health Database (ProQuest)
from 1980-01-03 to 3 months ago
PubMed
33185990
DOI
10.1056/nejmoa2025797
Knihovny.cz E-resources
- MeSH
- Cardiotonic Agents adverse effects pharmacology therapeutic use MeSH
- Cardiovascular Diseases mortality MeSH
- Myocardial Contraction drug effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Urea adverse effects analogs & derivatives pharmacology therapeutic use MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Cardiac Myosins drug effects metabolism MeSH
- Heart Failure, Systolic drug therapy metabolism physiopathology MeSH
- Stroke Volume MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. METHODS: We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes. RESULTS: During a median of 21.8 months, a primary-outcome event occurred in 1523 of 4120 patients (37.0%) in the omecamtiv mecarbil group and in 1607 of 4112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 to 0.99; P = 0.03). A total of 808 patients (19.6%) and 798 patients (19.4%), respectively, died from cardiovascular causes (hazard ratio, 1.01; 95% CI, 0.92 to 1.11). There was no significant difference between groups in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score. At week 24, the change from baseline for the median N-terminal pro-B-type natriuretic peptide level was 10% lower in the omecamtiv mecarbil group than in the placebo group; the median cardiac troponin I level was 4 ng per liter higher. The frequency of cardiac ischemic and ventricular arrhythmia events was similar in the two groups. CONCLUSIONS: Among patients with heart failure and a reduced ejection, those who received omecamtiv mecarbil had a lower incidence of a composite of a heart-failure event or death from cardiovascular causes than those who received placebo. (Funded by Amgen and others; GALACTIC-HF ClinicalTrials.gov number, NCT02929329; EudraCT number, 2016-002299-28.).
British Heart Foundation Cardiovascular Research Centre
Commenius University Bratislava Slovakia
Cytokinetics South San Francisco California
Department of Cardiology Inselspital Bern University Hospital University of Bern Bern Switzerland
Department of Cardiology Queen Giovanna University Hospital and Medical University Sofia Bulgaria
Division of Cardiovascular Medicine Brigham and Women's Hospital and Harvard Medical School Boston
Dokuz Eylul University Izmir Turkey
Estudios Clínicos Latino América Rosario Argentina
Fundación Cardiovascular de Colombia Floridablanca Colombia
Heart and Vascular Institute Henry Ford Hospital Detroit
Institute of Cardiology Kyiv Ukraine
Instituto Nacional de Cardiología Mexico City
Internal Cardiology Department St Ann Hospital and Masaryk University Brno Brno Czech Republic
Libin Cardiovascular Institute and Cumming School of Medicine University of Calgary Calgary AB
Medical University of Vienna Vienna
Middlemore Hospital Otahuhu Auckland New Zealand
Montreal Heart Institute and Université de Montréal Montreal
National and Kapodistrian University of Athens Attikon University Hospital Athens
Pontificia Universidad Católica de Chile Santiago
Robertson Centre for Biostatistics and Clinical Trials Institute of Health and Wellbeing
Saarland University Universitätsklinikum des Saarlandes Homburg Germany
Saitama Citizens Medical Center Saitama Japan
St John of God Hospital Budapest Hungary
St Vincent's Hospital Sydney Darlinghurst NSW Australia
the British Heart Foundation Cardiovascular Research Centre both in the United Kingdom
the Heart and Vascular Institute Henry Ford Hospital Detroit
the Internal Cardiology Department St Ann Hospital and Masaryk University Brno Brno Czech Republic
the University of Cape Town Cape Town South Africa
the University of Groningen Groningen the Netherlands
the University of Minnesota Minneapolis
University Clinic of Lomonosov Moscow State University Moscow
University of Cape Town Cape Town South Africa
University of Groningen Groningen the Netherlands
University of Medicine and Pharmacy Carol Davila University and Emergency Hospital Bucharest Romania
University of Minnesota Minneapolis
University of North Carolina Chapel Hill
University of Utah Salt Lake City
References provided by Crossref.org
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- $a Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure / $c JR. Teerlink, R. Diaz, GM. Felker, JJV. McMurray, M. Metra, SD. Solomon, KF. Adams, I. Anand, A. Arias-Mendoza, T. Biering-Sørensen, M. Böhm, D. Bonderman, JGF. Cleland, R. Corbalan, MG. Crespo-Leiro, U. Dahlström, LE. Echeverria, JC. Fang, G. Filippatos, C. Fonseca, E. Goncalvesova, AR. Goudev, JG. Howlett, DE. Lanfear, J. Li, M. Lund, P. Macdonald, V. Mareev, SI. Momomura, E. O'Meara, A. Parkhomenko, P. Ponikowski, FJA. Ramires, P. Serpytis, K. Sliwa, J. Spinar, TM. Suter, J. Tomcsanyi, H. Vandekerckhove, D. Vinereanu, AA. Voors, MB. Yilmaz, F. Zannad, L. Sharpsten, JC. Legg, C. Varin, N. Honarpour, SA. Abbasi, FI. Malik, CE. Kurtz, GALACTIC-HF Investigators
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- $a BACKGROUND: The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. METHODS: We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes. RESULTS: During a median of 21.8 months, a primary-outcome event occurred in 1523 of 4120 patients (37.0%) in the omecamtiv mecarbil group and in 1607 of 4112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 to 0.99; P = 0.03). A total of 808 patients (19.6%) and 798 patients (19.4%), respectively, died from cardiovascular causes (hazard ratio, 1.01; 95% CI, 0.92 to 1.11). There was no significant difference between groups in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score. At week 24, the change from baseline for the median N-terminal pro-B-type natriuretic peptide level was 10% lower in the omecamtiv mecarbil group than in the placebo group; the median cardiac troponin I level was 4 ng per liter higher. The frequency of cardiac ischemic and ventricular arrhythmia events was similar in the two groups. CONCLUSIONS: Among patients with heart failure and a reduced ejection, those who received omecamtiv mecarbil had a lower incidence of a composite of a heart-failure event or death from cardiovascular causes than those who received placebo. (Funded by Amgen and others; GALACTIC-HF ClinicalTrials.gov number, NCT02929329; EudraCT number, 2016-002299-28.).
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- $a Böhm, Michael $u Saarland University, Universitätsklinikum des Saarlandes, Homburg, Germany
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- $a Fonseca, Cândida $u Hospital S. Francisco Xavier, Centro Hospitalar Lisboa Ocidental, NOVA Medical School, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal
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