Empagliflozin in heart failure patients with reduced ejection fraction: a randomized clinical trial (Empire HF)

Trials

Ida Gustafsson¹  Christian Tuxen¹  Morten Schou²  Jesper Jensen²  Mikael Kjær Poulsen³  Peter Hartmund Frederiksen³  Jacob Eifer Møller³  Massar Omar³  Lars Videbæk³  Emil Fosbøl⁴  Finn Gustafsson⁴  Lars Køber⁴  Niels Eske Bruun⁵  Caroline Kistorp⁶ 

[1] Department of Cardiology, Bispebjerg-Frederiksberg Hospital;Department of Cardiology, Herlev-Gentofte Hospital;Department of Cardiology, Odense University Hospital;Department of Cardiology, The Heart Centre, Rigshospitalet;Department of Cardiology, Zealand University Hospital;Department of Endocrinology, Rigshospitalet;

关键词: Heart failure;    SGLT2 inhibitors;    Mechanism;    Mode of action;    NT-proBNP;    Daily activity level;   

DOI  :  10.1186/s13063-019-3474-5

来源: DOAJ

【 摘 要 】

Abstract Background Data from recent cardiovascular outcome trials in patients with type 2 diabetes (T2D) suggest that sodium-glucose cotransporter 2 (SGLT2) inhibitors can prevent development of heart failure (HF) and prolong life in patients without HF. Ongoing event-driven trials are investigating whether the same effect is present in patients with well-defined HF. The mechanism behind the effect of SGLT2 inhibitors in patients with T2D and the potential effect in patients with overt HF is presently unknown. Methods This is a randomized, double-blinded, placebo-controlled, parallel group, clinical trial including HF patients with reduced left ventricular ejection fraction (HFrEF) with an ejection fraction ≤ 40% on optimal therapy recruited from specialized HF clinics in Denmark. The primary aim is to investigate the effect of the SGLT2 inhibitor empagliflozin on N-terminal pro-brain natriuretic peptide (NT-proBNP). Secondary endpoints include cardiac biomarkers, function and hemodynamics, metabolic and renal parameters, daily activity level, and quality of life. Patients are assigned 1:1 to 90 days treatment with empagliflozin 10 mg daily or placebo. Patients with T2D are required to be on recommended doses of anti-glycemic therapy with a hemoglobin A1c (HbA1c) of 6.5–10.0% (48–86 mmol/mol). To show a between-group difference in the change of NT-proBNP of 30%, a total of 189 patients will be included. Discussion The Empire HF trial will elucidate the effects and modes of action of empagliflozin in HFrEF patients with and without T2D and provide important mechanistic data which will complement ongoing event-driven trials. Trial registration Clinicaltrialsregister.eu, EudraCT Number 2017-001341-27. Registered on 29 May 2017. ClinicalTrials.gov, NCT03198585. Registered on 26 June 2017.

【 授权许可】

Unknown