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

Teerlink, J. R. et al. (2020) 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, 22(11), pp. 2160-2171. (doi: 10.1002/ejhf.2015) (PMID:32985088) (PMCID:PMC7756903)

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 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 functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF 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.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: McMurray, Professor John and Cleland, Professor John
• Authors: Teerlink, J. R., Diaz, R., Felker, G. M., McMurray, J. J.V., Metra, M., Solomon, S. D., Adams, K. F., Anand, I., Arias‐Mendoza, A., Biering‐Sørensen, T., Böhm, M., Bonderman, D., Cleland, J. G.F., Corbalan, R., Crespo‐Leiro, M. G., Dahlström, U., Diaz, R., Echeverria Correa, L. E., Fang, J. C., Filippatos, G., Fonseca, C., Goncalvesova, E., Goudev, A. R., Howlett, J. G., Lanfear, D. E., Lund, M., Macdonald, P., Mareev, V., Momomura, S.‐i., O'Meara, E., Parkhomenko, A., Ponikowski, P., Ramires, F. J. A., Serpytis, P., Sliwa, K., Spinar, J., Suter, T. M., Tomcsanyi, J., Vandekerckhove, H., Vinereanu, D., Voors, A. A., Yilmaz, M. B., Zannad, F., Sharpsten, L., Legg, J. C., Abbasi, S. A., Varin, C., Malik, F. I., Kurtz, C. E., Besada, D. A., Majul, C. R., Bruno, M. R. L., Sassone, S., Avaca, H. A., Rasmussen, M., Aiub, J. R., Hominal, M. A., Perna, E., Duran, R. O. G., Schiavi, L., Marquez, L. L. L., Vilamajo, O. A. G., Mackinnon, I., Fuente, R. A. L., Montana, O. R., Novaretto, L., Guerrero, R. A. A., Brasca, D. G., Prado, A., Garrido, M. A., Luquez, H., Martinez, D. F., Nicolosi, L., Parody, M. L., Zaidman, C., Berra, F. C., Ibañez, J., Zapata, G., Caccavo, A., Colque, R., Diez, M., Poy, C., Salomone, O. A., Vogel, D., Bordonava, A. P., Fernandez, A., French, J., Atherton, J., Hamilton, A., Begg, A., Abhayaratna, W., Judkins, C., Macdonald, P., De Pasquale, C., McKenzie, S., Amerena, J., Szto, G., Kearney, L., Zimmet, H., Sverdlov, A., Beltrame, J., Korczyk, D., Sindone, A., Moertl, D., Huber, K., Huelsmann, M., Ablasser, K., Ebner, C., Siostrzonek, P., Drexel, H., Poelzl, G., Dujardin, K., Dupont, M., Buysschaert, I., Lancellotti, P., Vandekerckhove, H., Droogne, W., Chouchane, I., Silveira, F., Rassi, S., Reis, G., Filho, P. P., Simoes, M. V., Braga, J. C., Giorgeto, F. E., Ferraz, A., Jaeger, C. P., Saraiva, J. F., Tognon, A., Cardoso, J., Greco, O., Paiva, M. S., Paolino, B., Filho, O. C., Maia, L. N., Silva, R., Canesin, M., Rossi, P. R. F., Fortes, J. A. R., Cerci, R. J., Manenti, E. R. F., Leaes, P. E., Silva Neto, L. B., Souza, W. K. B., Bacal, F., Chaves, R., Ramires, F., Vidotti, M. H., Barros e Silva, P. G. M., Piegas, L. S., Todorov, G., Tzekova, M., Goudev, A., Mincheva, V., Vasilev, I., Tisheva‐ Gospodinova, S., Petrov, I., Postadzhiyan, A., Velikov, C., Dimov, B., O'Meara, E., Constance, C., Phaneuf, D.‐C., Mielniczuk, L., Pandey, A. S., Senaratne, M., Zieroth, S., Savard, D., Stewart, R., Huynh, T., Giannetti, N., Moe, G., Bourgeois, R., Ezekowitz, J., Hartleib, M., Sussex, B., Babapulle, M., Chehayeb, R., Gaudet, D., McKelvie, R., Nguyen, V., Roth, S., Gupta, M., Pesant, Y., Rupka, D., Bhargava, R., Costa‐Vitali, A., Proulx, G., Vega, M., Potthoff, S., Cid, M. C. S., Sepulveda, A. M. V., Zanetti, F. T. L., Corbalan, R., Gajardo, V. A. S., Kindel, C. C., Jofre, C. P. P., Segarra, J. L. C., Venegas, M. E. R., Hidalgo, M. Y., Jalaf, M. G. 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• Subjects: R Medicine > R Medicine (General)
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre
• Journal Name: European Journal of Heart Failure
• Publisher: Wiley
• ISSN: 1388-9842
• ISSN (Online): 1879-0844
• Published Online: 27 September 2020
• Copyright Holders: Copyright © 2020 The Authors
• First Published: First published in European Journal of Heart Failure 22(11): 2160-2171
• Publisher Policy: Reproduced under a Creative Commons License