The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation.
A 24-month randomized, single-blind, placebo-controlled trial to investigate the efficacy of empagliflozin to reduce atrial fibrillation burden in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation in which a rhythm control strategy is indicated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Empagliflozin 10 mg oral tablet, once daily, for 24 months
Empagliflozin matching placebo, once daily, for 24 months
Miulli General Hospital
Acquaviva delle Fonti, Bari, Italy
Maintenance of sinus rhythm after the blanking period
To compare the proportion of patients with sinus rhythm from 90 days after baseline to end of study period
Time frame: From 90 days after baseline to 24-months
Composite of major adverse cardiovascular events
To compare the incidence at the end of study period of major adverse cardiovascular events (death, non-fatal myocardial infarction, acute cerebrovascular events)
Time frame: Baseline through 24-months
Hospitalizations for cardiovascular events
To compare the incidence at the end of study period of hospitalizations for cardiovascular events
Time frame: Baseline through 24-months
Safety endpoint: Incidence of adverse events
To estimate the incidence of adverse events
Time frame: Baseline through 24-months
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