Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction: GALACTIC‐HF baseline characteristics and comparison with contemporary clinical trials - Université de Lorraine Access content directly
Journal Articles European Journal of Heart Failure Year : 2020

Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction: GALACTIC‐HF baseline characteristics and comparison with contemporary clinical trials

1 Veterans Affairs Medical Center, San Francisco, California
2 UC San Francisco - University of California [San Francisco]
3 Estudios Clinicos Latino America (ECLA)
4 Duke Clinical Research Institute
5 Duke University [Durham]
6 BHF GCRC - British Heart Foundation Glasgow Cardiovascular Research Centre
7 Azienda Socio Sanitaria Territoriale Spedali Civili di Brescia [Brescia]
8 Brigham and Women’s Hospital [Boston, MA]
9 Department Biostatistics University of North Carolina
10 University of Minnesota System
11 National Institute of Cardiology, Mexico City
12 BWH - Brigham & Women’s Hospital [Boston]
13 Herlev and Gentofte Hospital
14 UKS - Saarland University Hospital
15 Medizinische Universität Wien = Medical University of Vienna
16 NHLI - National Heart and Lung Institute [London]
17 University of Glasgow
18 UC - Pontificia Universidad Católica de Chile
19 UDC - University of A Coruña
20 LIU - Linköping University
21 Fundación Cardiovascular de Colombia [Floridablanca]
22 University of Utah
23 NKUA - National and Kapodistrian University of Athens
24 NOVA - Universidade Nova de Lisboa = NOVA University Lisbon
25 Commenius University in Bratislava - Univerzita Komenského
26 EAS - European Atherosclerosis Society [Göteborg, Sweden]
27 University of Calgary
28 Henry Ford Hospital
29 Middlemore Hospital
30 St. Vincent's Hospital, Sydney
31 MSU - Lomonosov Moscow State University
32 Saitama Citizens Medical Center
33 Montreal Heart Institute - Institut de Cardiologie de Montréal
34 UdeM - Université de Montréal
35 NSC/MDSIC - National Scientific Center "M.D. Strazhesko Institute of Cardiology" [Kyiv, Ukraine]
36 Wrocław Medical University
37 USP - Universidade de São Paulo = University of São Paulo
38 Vilnius University [Vilnius]
39 University of Cape Town
40 University Hospital Brno
41 University of Bern
42 Inselspital - Bern University Hospital [Berne]
43 Saint John of God Clinical Research Centre
44 AZ Sint-Lucas
45 UMPCD - University of Medicine and Pharmacy “Carol Davila” Bucharest
46 Emergency Hospital Floreasca Bucharest
47 University of Groningen [Groningen]
48 DEÜ - Dokuz Eylül Üniversitesi = Dokuz Eylül University [Izmir]
49 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
50 CIC-P - Centre d'investigation clinique plurithématique Pierre Drouin [Nancy]
51 INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy]
52 Cardiovascular & Renal Clinical Trialists - CRCT - French-Clinical Research Infrastructure Network - F-CRIN [Paris]
53 Amgen Inc.
54 Laboratoire Servier
55 Cytokinetics Inc
James C Fang
  • Function : Author
Mayanna Lund
  • Function : Author
Lucie Sharpsten
  • Function : Author
Jason C Legg
  • Function : Author
Siddique A Abbasi
  • Function : Author
Claire Varin
  • Function : Author
Fady I Malik
  • Function : Author
Christopher E Kurtz
  • Function : Author


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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Dates and versions

hal-03717286 , version 1 (08-07-2022)



John R Teerlink, Rafael Diaz, G. Michael Felker, John J.V. Mcmurray, Marco Metra, et al.. Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction: GALACTIC‐HF baseline characteristics and comparison with contemporary clinical trials. European Journal of Heart Failure, 2020, 22 (11), pp.2160-2171. ⟨10.1002/ejhf.2015⟩. ⟨hal-03717286⟩
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