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)

• Published in: European journal of heart failure Vol. 21; no. 5; pp. 665 - 675
• Main 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., McMurray, John JV, DeMets, David L, Inzucchi, Silvio E, Kosiborod, Mikhail N, Langkilde, Anna Maria, Martinez, Felipe A, Sabatine, Marc S, Solomon, Scott D, Diez, Mirta, Nicolau, Jose, Katova, Tzvetana, O'Meara, Eileen, Howlett, Jonathan, Verma, Subodh, Ge, Junbo, Belohlavek, Jan, Schou, Morten, Böhm, Michael, Merkely, Bela, Chopra, Vijay, Kitakaze, Masafumi, de Boer, Rudolf A., Drozdz, Jaroslaw, Tereshchenko, Sergey, Dukat, Andrej, Ljungman, Charlotta, Chiang, Chern‐En, Petrie, Mark, Desai, Akshay, Anand, Inder, Pham, Vinh Nguyen, Pfeffer, Marc A., Pocock, Stuart, Swedberg, Karl, Rouleau, Jean L., Chaturvedi, Nishi, Ivanovich, Peter, Levey, Andrew S., Christ‐Schmidt, Heidi, Held, Claes, Varenhorst, Christoph, Christersson, Christina, Mann, Johannes, Holmgren, Pernilla, Hallberg, Theresa, Langkilde, AnnaMaria, Denison, Hans, Reicher, Barry, Fox, Ywonne, Forsby, Mikael, Alenhag, Eva‐Lena, Nilsson, Ann, Kazanowska, Kinga, Olofsson, Eva Lavik, Karup, Cathrine, Ekedahl‐Berggren, Maria, Klockargård, Anna‐Lena, Kempe, Karin, Selvén, Mathilda
• Format: Journal Article
• Language: English
• Published: Oxford, UK John Wiley & Sons, Ltd 01.05.2019
• Subjects: Benzhydryl Compounds - therapeutic use; Cardiovascular Diseases - mortality; Chronic Disease; Clinical trial; Diabetes Mellitus, Type 2 - complications; Double-Blind Method; Glucosides - therapeutic use; Heart failure; Heart Failure - blood; Heart Failure - complications; Heart Failure - drug therapy; Heart Failure - physiopathology; Hospitalization - statistics & numerical data; Humans; Natriuretic Peptide, Brain - blood; Patient Reported Outcome Measures; Peptide Fragments - blood; Sodium-glucose co-transporter 2 inhibitor; Sodium-Glucose Transporter 2 Inhibitors - therapeutic use; Stroke Volume; Study Design; Trial Designs; Type 2 diabetes mellitus; Heart failure; Clinical trial; Type 2 diabetes mellitus; Sodium-glucose co-transporter 2 inhibitor
• ISSN: 1388-9842; 1879-0844; 1879-0844
• DOI: 10.1002/ejhf.1432

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 m2. 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.