Dapagliflozin in heart failure with preserved and mildly reduced ejection fraction: rationale and design of the DELIVER trial

Solomon, S. D. et al. (2021) Dapagliflozin in heart failure with preserved and mildly reduced ejection fraction: rationale and design of the DELIVER trial. European Journal of Heart Failure, 23(7), pp. 1217-1225. (doi: 10.1002/ejhf.2249) (PMID:34051124)

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Abstract

Background: Sodium glucose co-transporter type 2 (SGLT2) inhibitors, originally developed as glucose lowering agents, have been shown to reduce heart failure hospitalizations in patients with type 2 diabetes without established heart failure, and in patients with heart failure with and without diabetes. Their role in patients with heart failure with preserved and mildly reduced ejection fraction remains unknown. Design and Methods: Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure (DELIVER) is an international, multi-center, parallel group, event-driven, randomized, double-blind trial in patients with chronic heart failure and left ventricular ejection fraction (LVEF) greater than 40%, comparing the effect of dapagliflozin 10 mg, compared with placebo, once daily, in addition to standard of care. Patients with or without diabetes, with signs and symptoms of heart failure, a left ventricular ejection fraction > 40%, elevation in natriuretic peptides and evidence of structural heart disease are eligible. The primary endpoint is time to first cardiovascular death or worsening heart failure event (heart failure hospitalization or urgent heart failure visit), and will be assessed in dual primary analyses – the full population and in those with LVEF < 60%. The study is event drive and will target 1117 primary events. A total of 6263 patients have been randomized. Conclusions: DELIVER will determine the efficacy and safety of the SGLT2 inhibitor dapagliflozin, added to conventional therapy, in patients with heart failure and preserved and mildly reduced ejection fraction. Clinicaltrials.gov NCT03619213.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McMurray, Professor John
Authors: Solomon, S. D., Boer, R. A., DeMets, D., Hernandez, A. F., Inzucchi, S. E., Kosiborod, M. N., Lam, C. S. P., Martinez, F., Shah, S. J., Lindholm, D., Wilderäng, U., Öhrn, F., Claggett, B., Langkilde, A. M., Petersson, M., and McMurray, J. J.V.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
Journal Name:European Journal of Heart Failure
Publisher:Wiley
ISSN:1388-9842
ISSN (Online):1879-0844
Published Online:29 May 2021
Copyright Holders:Copyright © 2021 The Authors
First Published:First published in European Journal of Heart Failure 23(7): 1217-1225
Publisher Policy:Reproduced under a Creative Commons License

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