The study is designed as a prospective randomized, controlled, double-blinded phase II trial
to examine the effect of the SGLT2 inhibitor empagliflozin, in comparison with placebo on
cardiovascular outcome parameters in kidney failure patients undergoing replacement therapy
with hemodialysis.
The primary endpoint is the change (∆) in left ventricular mass indexed to body surface area
(LVMi) from baseline to 6 months measured by cardiac magnetic resonance imaging.
Null and alternative hypotheses:
H0: There is no difference in the ∆ Left Ventricular Mass indexed to BSA after six months of
treatment, comparing patients having received the SGLT2-Inhibitor Empagliflozin versus
placebo.
H1: There is a difference in the ∆ Left Ventricular Mass indexed to BSA comparing patients
having received the SGLT2-Inhibitor Empagliflozin versus placebo.