Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure
Status:
Completed
Trial end date:
2019-09-18
Target enrollment:
Participant gender:
Summary
Acute decompensated heart failure is the fastest growing disease in the world and the leading
cause of hospital admissions worldwide. Short term mortality and rehospitalization are
extremely high (20-30% within 3-6 months) and there is no therapy available that improves
clinical outcome in these patients. Empagliflozin is a selective inhibitor of sodium glucose
co-transporter with diuretic and renal- protective properties. In patients with type 2
diabetes at high risk for cardiovascular events, empagliflozin reduced the risk of
hospitalization for heart failure by 35%. Based on the promising pharmacological profile of
empagliflozin in relation to the needs for treatment of acute decompensated heart failure, we
hypothesize that empagliflozin exerts positive effects in acute decompensated heart failure,
with or without diabetes,
This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in
subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be
randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo.