Baseline Characteristics of Patients With HF With Mildly Reduced and Preserved Ejection Fraction: DELIVER Trial

Scott D. Solomon*, Muthiah Vaduganathan, Brian L. Claggett, Rudolf A. de Boer, David DeMets, Adrian F. Hernandez, Silvio E. Inzucchi, Mikhail N. Kosiborod, Carolyn S.P. Lam, Felipe Martinez, Sanjiv J. Shah, Jan Belohlavek, Chern En Chiang, C. Jan Willem Borleffs, Josep Comin-Colet, Dan Dobreanu, Jaroslaw Drozdz, James C. Fang, Marco Antonio Alcocer Gamba, Waleed Al HabeebYaling Han, Jose Walter Cabrera Honorio, Stefan P. Janssens, Tsvetana Katova, Masafumi Kitakaze, Bela Merkely, Eileen O'Meara, Jose Francisco Kerr Saraiva, Sergey N. Tereschenko, Jorge Thierer, Orly Vardeny, Subodh Verma, Pham Nguyen Vinh, Ulrica Wilderäng, Natalia Zaozerska, Daniel Lindholm, Magnus Petersson, John J.V. McMurray

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Objectives: This report describes the baseline clinical profiles and management of DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) trial participants and how these compare with those in other contemporary heart failure with preserved ejection fraction trials. Background: The DELIVER trial was designed to evaluate the effects of the sodium-glucose cotransporter–2 inhibitor dapagliflozin on cardiovascular death, heart failure (HF) hospitalization, or urgent HF visits in patients with HF with mildly reduced and preserved left ventricular ejection fraction (LVEF). Methods: Adults with symptomatic HF and LVEF >40%, with or without type 2 diabetes mellitus, elevated N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels, and evidence of structural heart disease were randomized to dapagliflozin 10 mg once daily or matching placebo. Results: A total of 6,263 patients were randomized (mean age: 72 ± 10 years; 44% women; 45% type 2 diabetes mellitus; 45% with body mass index ≥30 kg/m2; and 57% with history of atrial fibrillation or flutter). Most participants had New York Heart Association functional class II symptoms (75%). Baseline mean LVEF was 54.2 ± 8.8% and median NT-proBNP of 1,399 pg/mL (IQR: 962 to 2,210 pg/mL) for patients in atrial fibrillation/flutter compared with 716 pg/mL (IQR: 469 to 1,281 pg/mL) in those who were not. Patients in both hospitalized and ambulatory settings were enrolled, including 10% enrolled in-hospital or within 30 days of a hospitalization for HF. Eighteen percent of participants had HF with improved LVEF. Conclusions: DELIVER is the largest and broadest clinical trial of this population to date and enrolled high-risk, well-treated patients with HF with mildly reduced and preserved LVEF. (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure [NCT03619213])

Original languageEnglish (US)
Pages (from-to)184-197
Number of pages14
JournalJACC: Heart Failure
Volume10
Issue number3
DOIs
StatePublished - Mar 2022

Keywords

  • SGLT-2 inhibitors
  • clinical trials
  • heart failure with mildly reduced ejection fraction
  • heart failure with preserved ejection fraction

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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