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

John R. Teerlink, Rafael Diaz, G. Michael Felker, John J.V. McMurray, Marco Metra, Scott D. Solomon, Kirkwood F. Adams, Inder Anand, Alexandra Arias-Mendoza, Tor Biering-Sørensen, Michael Böhm, Diana Bonderman, John G.F. Cleland, Ramon Corbalan, Maria G. Crespo-Leiro, Ulf Dahlström, Luis E. Echeverria Correa, James C. Fang, Gerasimos Filippatos, Cândida FonsecaEva Goncalvesova, Assen R. Goudev, Jonathan G. Howlett, David E. Lanfear, Mayanna Lund, Peter Macdonald, Vyacheslav Mareev, Shin ichi Momomura, Eileen O'Meara, Alexander Parkhomenko, Piotr Ponikowski, Felix J.A. Ramires, Pranas Serpytis, Karen Sliwa, Jindrich Spinar, Thomas M. Suter, Janos Tomcsanyi, Hans Vandekerckhove, Dragos Vinereanu, Adriaan A. Voors, Mehmet B. Yilmaz, Faiez Zannad, Lucie Sharpsten, Jason C. Legg, Siddique A. Abbasi, Claire Varin, Fady I. Malik, Christopher E. Kurtz

Research output: Contribution to journalArticlepeer-review

16 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)2160-2171
JournalEUROPEAN JOURNAL OF HEART FAILURE
Volume22
Issue number11
DOIs
Publication statusPublished - Nov 2020

Keywords

  • Cardiac myosin activator
  • Cardiovascular outcomes trial
  • Heart failure
  • Inotrope
  • Myotrope
  • Omecamtiv mecarbil

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