NCT04625946

Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is being done to determine if metformin, a drug which is normally used in diabetes, can reduce atrial fibrillation in patients who are having an ablation for atrial fibrillation (AF). Atrial fibrillation is an abnormal heart rhythm which research has shown is related in part to obesity and diabetes. It is anticipated that the participants treated in the metformin arm will have greater freedom from recurrent atrial arrhythmias after ablation. Eligible participants enrolled in the trial will be assigned to one of the treatment arms (no treatment or metformin) and have follow-up visits up to approximately 1 year after the ablation. Additionally, all patients will also receive education on lifestyle changes and exercise which are standard of care.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Metformin	Metformin immediate release will be initiated at 250 milligrams (mg) daily (orally), and increased as tolerated to 2000 mg daily over a four week period. If a patient is unable to tolerate a dose increase they will return to their last tolerated dose after omitting one days dosing. 0 to Six weeks after the initiation of drug the patient will undergo (standard of care) ablation with the intent of achieving rhythm control. Participants will stay on the metformin 12 months after the ablation. In addition, all participants will receive education on lifestyle changes and exercise which are standard of care as well as have a discussion with their treating electrophysiologist and receive a handout.
BEHAVIORAL	Recommendations for lifestyle modification.	All subjects will receive education on lifestyle changes and exercise which are standard of care. This will include discussion with their treating electrophysiologist and a handout.
DEVICE	AliveCor	Device will be used in order to record an electrocardiogram during symptoms perceived to be AF. All patients will be instructed to transmit at least once per week.

Timeline

• Start date: 2021-01-19
• Primary completion: 2025-07-01
• Completion: 2025-08-10
• First posted: 2020-11-12
• Last updated: 2025-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study