Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction: GALACTIC-HF baseline characteristics and comparison with contemporary clinical trials.
- Teerlink JR Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, CA, USA.
- Diaz R Estudios Clinicos Latino America (ECLA), Rosario, Argentina.
- Felker GM Division of Cardiology, Duke University School of Medicine and Duke Clinical Research Institute, Durham, NC, USA.
- McMurray JJV British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
- Metra M Cardiology, ASST Spedali Civili; Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
- Solomon SD Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
- Adams KF University of North Carolina, Chapel Hill, NC, USA.
- Anand I University of Minnesota, Minneapolis, MN, USA.
- Arias-Mendoza A Instituto Nacional de Cardiologìa, Mexico City, Mexico.
- Biering-Sørensen T Department of Cardiology, Herlev & Gentofte Hospital & Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
- Böhm M Saarland University, Universitätsklinikum des Saarlandes, Homburg, Germany.
- Bonderman D Medical University of Vienna, Vienna, Austria.
- Cleland JGF National Heart and Lung Institute, Imperial College, London, UK.
- Corbalan R Pontificia Universidad Catolica de Chile, Santiago, Chile.
- Crespo-Leiro MG Complexo Hospitalario Universitario A Coruña (CHUAC). CIBERCV. INIBIC. Universidade da Coruña, A Coruña, Spain.
- Dahlström U Department of Cardiology and Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden.
- Echeverria Correa LE Fundacion Cardiovascular de Colombia, Floridablanca, Colombia.
- Fang JC University of Utah, Salt Lake City, UT, USA.
- Filippatos G University of Athens, Athens, Greece.
- Fonseca C Hospital S. Francisco Xavier, CHLO; NOVA Medical School, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal.
- Goncalvesova E Commenius Universtity, Bratislava, Slovakia.
- Goudev AR Department of Cardiology, Queen Giovanna University Hospital and Medical University, Sofia, Bulgaria.
- Howlett JG Libin Cardiovascular Institute and Cumming School of Medicine, University of Calgary, Calgary, Canada.
- Lanfear DE Henry Ford Heart and Vascular Institute, Detroit, MI, USA.
- Lund M Middlemore Hospital, Auckland, New Zealand.
- Macdonald P St. Vincent's Hospital Sydney, Darlinghurst, Australia.
- Mareev V University Clinic of Lomonosov Moscow State University, Moscow, Russia.
- Momomura SI Saitama Citizens Medical Center, Saitama, Japan.
- O'Meara E Montreal Heart Institute and Université de Montréal, Montreal, Canada.
- Parkhomenko A Institute of Cardiology, Kyiv, Ukraine.
- Ponikowski P Wroclaw Medical University, Wroclaw, Poland.
- Ramires FJA Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
- Serpytis P Vilnius University, Vilnius, Lithuania.
- Sliwa K University of Cape Town, Johannesburg, South Africa.
- Spinar J University Hospital Brno, Brno, Czech Republic.
- Suter TM Bern University Hospital, University of Bern, Bern, Switzerland.
- Tomcsanyi J St. John of God Hospital, Budapest, Hungary.
- Vandekerckhove H AZ Sint-Lucas, Ghent, Belgium.
- Vinereanu D University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania.
- Voors AA University of Groningen, Groningen, The Netherlands.
- Yilmaz MB Dokuz Eylul University, Izmir, Turkey.
- Zannad F Université de Lorraine, Inserm INI CRCT, CHRU Nancy, Nancy, France.
- Sharpsten L Amgen, Inc., Thousand Oaks, CA, USA.
- Legg JC Amgen, Inc., Thousand Oaks, CA, USA.
- Abbasi SA Amgen, Inc., Thousand Oaks, CA, USA.
- Varin C Servier, Suresnes, France.
- Malik FI Cytokinetics, Inc., South San Francisco, CA, USA.
- Kurtz CE Amgen, Inc., Thousand Oaks, CA, USA.
- 2020-09-28
Published in:
- European journal of heart failure. - 2020
Cardiac myosin activator
Cardiovascular outcomes trial
Heart failure
Inotrope
Myotrope
Omecamtiv mecarbil
English
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.
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.
- Language
-
- English
- Open access status
- hybrid
- Identifiers
-
- DOI 10.1002/ejhf.2015
- PMID 32985088
- Persistent URL
- https://folia.unifr.ch/global/documents/234587
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