Empagliflozin Versus Placebo on the Rate of Arrhythmic Events in Heart Failure Patients
Status:
Unknown status
Trial end date:
2020-06-01
Target enrollment:
Participant gender:
Summary
Empagliflozin treatment in high cardiovascular risk patients has been shown to have a
relatively rapid powerful capability in reducing cardiovascular mortality. Among the
suggested mechanisms mediating this effect of empagliflozin, anti-arrhythmic effect (AAE) has
the highest potential to translate into a rapid clinical beneficial effect on cardiovascular
mortality, while other mechanisms are known to have a lag in their clinical effect based on
data from previous studies. Based on this assumption, the study driving hypothesis is that
the effect of empagliflozin on the rate of cardiovascular death may be mediated by a direct
effect on the risk for arrhythmic events (via a direct or an indirect effect on the
myocardium). The current study aims at assessing the effect of empagliflozin on arrhythmias
in diabetic patients with HF with reduced ejection fraction and relatively high arrhythmic
burden. The objective of the current study is to demonstrate the effect of empagliflozin
compared to placebo on the rate of ventricular arrhythmic events in type 2 diabetes patients
with heart failure with reduced ejection fraction and high risk arrhythmic profile.