Empagliflozin and Atrial Fibrillation Treatment

Sponsor
Miulli General Hospital
Study ID
NCT04583813
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Empagliflozin 10 mg oral tablet, once daily, for 24 months
  • Placebo — OTHER
    Empagliflozin matching placebo, once daily, for 24 months

Study Details

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.

Key Dates

Start date
Sep 30, 2021
Status verified
Apr 2021
Primary completion
Jan 31, 2024
Completion
Apr 30, 2024

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Empagliflozin
    Empagliflozin 10 mg oral tablet, once daily, for 24 months
  • Placebo Comparator: Placebo
    Empagliflozin matching placebo oral tablet, once daily for 24 months

Primary Outcome Measure

Maintenance of sinus rhythm after the blanking period [ Time Frame: From 90 days after baseline to 24-months ]

Central Contacts

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