TY - JOUR
T1 - Baseline Characteristics of Patients With HF With Mildly Reduced and Preserved Ejection Fraction
T2 - DELIVER Trial
AU - Solomon, Scott D.
AU - Vaduganathan, Muthiah
AU - Claggett, Brian L.
AU - de Boer, Rudolf A.
AU - DeMets, David
AU - Hernandez, Adrian F.
AU - Inzucchi, Silvio E.
AU - Kosiborod, Mikhail N.
AU - Lam, Carolyn S.P.
AU - Martinez, Felipe
AU - Shah, Sanjiv J.
AU - Belohlavek, Jan
AU - Chiang, Chern En
AU - Willem Borleffs, C. Jan
AU - Comin-Colet, Josep
AU - Dobreanu, Dan
AU - Drozdz, Jaroslaw
AU - Fang, James C.
AU - Alcocer Gamba, Marco Antonio
AU - Al Habeeb, Waleed
AU - Han, Yaling
AU - Cabrera Honorio, Jose Walter
AU - Janssens, Stefan P.
AU - Katova, Tsvetana
AU - Kitakaze, Masafumi
AU - Merkely, Bela
AU - O'Meara, Eileen
AU - Kerr Saraiva, Jose Francisco
AU - Tereschenko, Sergey N.
AU - Thierer, Jorge
AU - Vardeny, Orly
AU - Verma, Subodh
AU - Vinh, Pham Nguyen
AU - Wilderäng, Ulrica
AU - Zaozerska, Natalia
AU - Lindholm, Daniel
AU - Petersson, Magnus
AU - McMurray, John J.V.
N1 - Publisher Copyright:
© 2022 The Authors
PY - 2022/3
Y1 - 2022/3
N2 - 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.
AB - 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.
KW - SGLT-2 inhibitors
KW - clinical trials
KW - heart failure with mildly reduced ejection fraction
KW - heart failure with preserved ejection fraction
UR - http://www.scopus.com/inward/record.url?scp=85124762482&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85124762482&partnerID=8YFLogxK
U2 - 10.1016/j.jchf.2021.11.006
DO - 10.1016/j.jchf.2021.11.006
M3 - Article
C2 - 35241246
AN - SCOPUS:85124762482
SN - 2213-1779
VL - 10
SP - 184
EP - 197
JO - JACC: Heart Failure
JF - JACC: Heart Failure
IS - 3
ER -
