Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

NCT ID: NCT04625946

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2025-08-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin

Standard of care ablation with recommendations for lifestyle modification and metformin.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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.

Recommendations for lifestyle modification.

Intervention Type: BEHAVIORAL

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.

AliveCor

Intervention Type: DEVICE

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.

Standard of care

Standard of care ablation with recommendations for lifestyle modification.

Group Type: OTHER

Recommendations for lifestyle modification.

Intervention Type: BEHAVIORAL

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.

AliveCor

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Other Intervention Names

Glucophage

Eligibility Criteria

Inclusion Criteria

• Body Mass Index (BMI) >25 kilograms / square meter (kg/m2) with plan for rhythm control of atrial fibrillation by catheter ablation
• All subjects must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria

• Individuals who are already taking metformin or other antidiabetic medications, including insulin
• Known diabetes
• Known allergy or Food and Drug Administration (FDA)-labeled contraindication to taking metformin (estimated glomerular filtration rate (eGFR)<30 millilitres per minute (mL/min)/1.73 square meters (m2), hypersensitivity to metformin, acute or chronic metabolic acidosis)
• Patients taking carbonic anhydrase inhibitors
• eGFR below 30 mL/min per 1.73 m2 or other clinical diagnosis of advanced renal disease
• Acute or chronic metabolic acidosis (serum bicarbonate <22 milliequivalents per liter (mEq/L))
• History of significant alcohol use (>2 drinks/day on average)
• History of hepatic dysfunction (serum bilirubin 1.5 times greater than ULN)
• History of New York Heart Association (NYHA) Class III or IV heart failure
• Pregnancy or nursing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Hakan Oral

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hakan Oral, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00174848

Identifier Type: -

Identifier Source: org_study_id