Empagliflozin in heart failure patients with reduced ejection fraction: a randomized clinical trial (Empire HF)
Posted on 2019-06-21 - 05:00
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.
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Jensen, Jesper; Omar, Massar; Kistorp, Caroline; Poulsen, Mikael; Tuxen, Christian; Gustafsson, Ida; et al. (2019). Empagliflozin in heart failure patients with reduced ejection fraction: a randomized clinical trial (Empire HF). figshare. Collection. https://doi.org/10.6084/m9.figshare.c.4551596.v1
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AUTHORS (14)
JJ
Jesper Jensen
MO
Massar Omar
CK
Caroline Kistorp
MP
Mikael Poulsen
CT
Christian Tuxen
IG
Ida Gustafsson
LK
Lars Køber
FG
Finn Gustafsson
EF
Emil Fosbøl
NB
Niels Bruun
LV
Lars Videbæk
PF
Peter Frederiksen
JM
Jacob Møller
MS
Morten Schou