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Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction: GALACTIC-HF baseline characteristics and comparison with contemporary clinical trials
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 Correa, JC....
Language English Country Great Britain
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
Medline Complete (EBSCOhost)
from 2000-03-01 to 1 year ago
Wiley Free Content
from 1999 to 1 year ago
PubMed
32985088
DOI
10.1002/ejhf.2015
Knihovny.cz E-resources
- MeSH
- Ventricular Function, Left drug effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Urea analogs & derivatives therapeutic use MeSH
- Randomized Controlled Trials as Topic MeSH
- Aged MeSH
- Heart Failure * drug therapy physiopathology MeSH
- Stroke Volume drug effects MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
AIMS: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is being tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF) trial. Here we describe the baseline characteristics of participants in GALACTIC-HF and how these compare with other contemporary trials. METHODS AND RESULTS: Adults with established HFrEF, New York Heart Association (NYHA) functional class ≥II, ejection fraction ≤35%, elevated natriuretic peptides and either current hospitalization for heart failure or history of hospitalization/emergency department visit for heart failure within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic-guided dosing: 25, 37.5, or 50 mg bid). A total of 8256 patients [male (79%), non-white (22%), mean age 65 years] were enrolled with a mean ejection fraction 27%, ischaemic aetiology in 54%, NYHA class II 53% and III/IV 47%, and median N-terminal pro-B-type natriuretic peptide 1971 pg/mL. Heart failure therapies at baseline were among the most effectively employed in contemporary heart failure trials. GALACTIC-HF randomized patients representative of recent heart failure registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure <100 mmHg (n = 1127), estimated glomerular filtration rate <30 mL/min/1.73 m2 (n = 528), and treated with sacubitril/valsartan at baseline (n = 1594). CONCLUSIONS: GALACTIC-HF enrolled a well-treated, high-risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation.
Amgen Inc Thousand Oaks CA USA
Bern University Hospital University of Bern Bern Switzerland
British Heart Foundation Cardiovascular Research Centre University of Glasgow Glasgow UK
Cardiology ASST Spedali Civili
Commenius Universtity Bratislava Slovakia
Complexo Hospitalario Universitario A Coruña CIBERCV INIBIC Universidade da Coruña A Coruña Spain
Cytokinetics Inc South San Francisco CA USA
Department of Cardiology Queen Giovanna University Hospital and Medical University Sofia Bulgaria
Dokuz Eylul University Izmir Turkey
Estudios Clinicos Latino America Rosario Argentina
Fundacion Cardiovascular de Colombia Floridablanca Colombia
Henry Ford Heart and Vascular Institute Detroit MI USA
Hospital S Francisco Xavier CHLO
Institute of Cardiology Kyiv Ukraine
Instituto Nacional de Cardiologìa Mexico City Mexico
Libin Cardiovascular Institute and Cumming School of Medicine University of Calgary Calgary Canada
Medical University of Vienna Vienna Austria
Middlemore Hospital Auckland New Zealand
Montreal Heart Institute and Université de Montréal Montreal Canada
National Heart and Lung Institute Imperial College London UK
NOVA Medical School Faculdade de Ciências Médicas Universidade Nova de Lisboa Lisbon Portugal
Pontificia Universidad Catolica de Chile Santiago Chile
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 Australia
Université de Lorraine Inserm INI CRCT CHRU Nancy Nancy France
University Clinic of Lomonosov Moscow State University Moscow Russia
University Hospital Brno Brno Czech Republic
University of Athens Athens Greece
University of Cape Town Johannesburg 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 MN USA
University of North Carolina Chapel Hill NC USA
University of Utah Salt Lake City UT USA
References provided by Crossref.org
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