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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....

. 2020 ; 22 (11) : 2160-2171. [pub] 20201027

Language English Country Great Britain

Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc21019879

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

AZ Sint Lucas Ghent Belgium

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 and Department of Health Medicine and Caring Sciences Linkoping University Linkoping Sweden

Department of Cardiology Herlev and Gentofte Hospital and Department of Biomedical Sciences Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark

Department of Cardiology Queen Giovanna University Hospital and Medical University Sofia Bulgaria

Department of Medical and Surgical Specialties Radiological Sciences and Public Health University of Brescia Brescia Italy

Division of Cardiology Duke University School of Medicine and Duke Clinical Research Institute Durham NC USA

Division of Cardiovascular Medicine Brigham and Women's Hospital and Harvard Medical School Boston MA USA

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 do Coração Hospital das Clínicas HCFMUSP Faculdade de Medicina Universidade de São Paulo São Paulo Brazil

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

Robertson Centre for Biostatistics and Clinical Trials Institute of Health and Wellbeing University of Glasgow Glasgow UK

Saarland University Universitätsklinikum des Saarlandes Homburg Germany

Saitama Citizens Medical Center Saitama Japan

Section of Cardiology San Francisco Veterans Affairs Medical Center and School of Medicine University of California San Francisco San Francisco CA USA

Servier Suresnes France

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

Vilnius University Vilnius Lithuania

Wroclaw Medical University Wroclaw Poland

References provided by Crossref.org

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$a 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.
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