A trial to evaluate the effect of the sodium–glucose co‐transporter 2 inhibitor dapagliflozin on morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction (DAPA‐HF). (21st March 2019)

• Record Type: Journal Article
• Authors: McMurray, John J.V.; DeMets, David L.; Inzucchi, Silvio E.; Køber, Lars; Kosiborod, Mikhail N.; Langkilde, Anna M.; Martinez, Felipe A.; Bengtsson, Olof; Ponikowski, Piotr; Sabatine, Marc S.; Sjöstrand, Mikaela; Solomon, Scott D.
• Other Names: McMurray John JV investigator.; DeMets David L investigator.; Inzucchi Silvio E investigator.; Køber Lars investigator.; Kosiborod Mikhail N investigator.; Langkilde Anna Maria investigator.; Martinez Felipe A investigator.; Ponikowski Piotr investigator.; Sabatine Marc S investigator.; Sjöstrand Mikaela investigator.; Solomon Scott D investigator.; Diez Mirta investigator.; Nicolau Jose investigator.; Katova Tzvetana investigator.; O'Meara Eileen investigator.; Howlett Jonathan investigator.; Verma Subodh investigator.; Ge Junbo investigator.; Belohlavek Jan investigator.; Schou Morten investigator.; Böhm Michael investigator.; Merkely Bela investigator.; Chopra Vijay investigator.; Kitakaze Masafumi investigator.; de Boer Rudolf A. investigator.; Drozdz Jaroslaw investigator.; Tereshchenko Sergey investigator.; Dukat Andrej investigator.; Ljungman Charlotta investigator.; Chiang Chern‐En investigator.; Petrie Mark investigator.; Desai Akshay investigator.; Anand Inder investigator.; Pham Vinh Nguyen investigator.; Pfeffer Marc A. investigator.; Pocock Stuart investigator.; Swedberg Karl investigator.; Rouleau Jean L. investigator.; Chaturvedi Nishi investigator.; Ivanovich Peter investigator.; Levey Andrew S. investigator.; Christ‐Schmidt Heidi investigator.; Held Claes investigator.; Varenhorst Christoph investigator.; Christersson Christina investigator.; Mann Johannes investigator.; Holmgren Pernilla investigator.; Hallberg Theresa investigator.; Langkilde AnnaMaria investigator.; Sjöstrand Mikaela investigator.; Denison Hans investigator.; Reicher Barry investigator.; Bengtsson Olof investigator.; Fox Ywonne investigator.; Forsby Mikael investigator.; Alenhag Eva‐Lena investigator.; Nilsson Ann investigator.; Kazanowska Kinga investigator.; Olofsson Eva Lavik investigator.; Karup Cathrine investigator.; Ekedahl‐Berggren Maria investigator.; Klockargård Anna‐Lena investigator.; Kempe Karin investigator.; Selvén Mathilda investigator.;
• Is Part Of: European journal of heart failure. Volume 21:Number 5(2019)
• Page Start: 665
• Page End: 675
• Publication Date: 2019-03-21
• Subjects: Clinical trial -- Heart failure -- Sodium–glucose co‐transporter 2 inhibitor -- Type 2 diabetes mellitus; Heart failure -- Periodicals; Heart Failure -- Periodicals; Insuffisance cardiaque -- Périodiques; Heart failure; Periodicals; 616.129005
• DOI: 10.1002/ejhf.1432
• Languages: English
• ISSNs: 1388-9842

Abstract

Abstract : Background: Sodium–glucose co‐transporter 2 (SGLT2) inhibitors have been shown to reduce the risk of incident heart failure hospitalization in individuals with type 2 diabetes who have, or are at high risk of, cardiovascular disease. Most patients in these trials did not have heart failure at baseline and the effect of SGLT2 inhibitors on outcomes in individuals with established heart failure (with or without diabetes) is unknown. Design and methods: The Dapagliflozin And Prevention of Adverse‐outcomes in Heart Failure trial (DAPA‐HF) is an international, multicentre, parallel group, randomized, double‐blind, study in patients with chronic heart failure, evaluating the effect of dapagliflozin 10 mg, compared with placebo, given once daily, in addition to standard care, on the primary composite outcome of a worsening heart failure event (hospitalization or equivalent event, i.e. an urgent heart failure visit) or cardiovascular death. Patients with and without diabetes are eligible and must have a left ventricular ejection fraction ≤ 40%, a moderately elevated N‐terminal pro B‐type natriuretic peptide level, and an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m 2 . The trial is event‐driven, with a target of 844 primary outcomes. Secondary outcomes include the composite of total heart failure hospitalizations (including repeat episodes), and cardiovascular death and patient‐reported outcomes. A total of 4744 patients have been randomized. Conclusions: DAPA‐HF will determine the efficacy and safety of the SGLT2 inhibitor dapagliflozin, added to conventional therapy, in a broad spectrum of patients with heart failure and reduced ejection fraction.