The EMPA-AHF trial is a multicentre, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of early initiation of once-daily oral empagliflozin 10 mg in patients hospitalized for patients with acute heart failure (AHF) who are at a high risk of adverse events.
Age of ≥20*
Provided written consent to participate in the study *If the patient is 90 years of age or older and cognitive decline is considered necessary, Mini-Cog should be used to confirm that its score is not less than 3.
eGFR <20 mL/min/1.73m2 at the time of admission
Already taking an SGLT2i within 3 months prior to hospitalization
Type 1 diabetes mellitus
Systolic blood pressure <90 mmHg
Parallel
Empagliflozin 10 MG
Drugonce-daily oral empagliflozin 10 mg
Placebo
DrugPlacebo matching empagliflozin 10 mg
A hierarchical composite endpoint consisting of death within 90 days, heart failure rehospitalization within 90 days, WHF during hospitalization, and urine output up to 48 hours after treatment initiation, assessed by the win ratio
WHF, worsening heart failure
A hierarchical composite endpoint consisting of death within 90 days, heart failure readmission within 90 days, and WHF during hospitalization
WHF, worsening heart failure
A composite endpoint consisting of WHF during hospitalization, death, heart failure rehospitalization, urgent visit for WHF, intensification of diuretic therapy, and worsening NYHA class within 90 days
WHF, worsening heart failure
Change in NT-proBNP from randomization to 48 hours
Diuretic response, calculated as urine output achieved by loop diuretics (40 mg intravenous furosemide-equivalent dose) at 48 h after treatment initiation
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Juntendo University
Lead sponsor
Boehringer Ingelheim
Collaborator
