NCT04583813

Empagliflozin and Atrial Fibrillation Treatment

Efficacy of Empagliflozin in Patients With Heart Failure and Atrial Fibrillation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Miulli General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atrial Fibrillation
• Heart Failure
• Obesity
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Empagliflozin	Empagliflozin 10 mg oral tablet, once daily, for 24 months
OTHER	Placebo	Empagliflozin matching placebo, once daily, for 24 months

Timeline

• Start date: 2021-09-01
• Primary completion: 2024-01-01
• Completion: 2024-04-01
• First posted: 2020-10-12
• Last updated: 2021-04-02

Locations

1 site across 1 country: Italy