Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

NCT04625946 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: HUM00174848
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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

Keywords

ablation

Outcome Measures

Primary Outcomes (1)

• Freedom from recurrent atrial arrhythmias by 12 months after a single ablation to eliminate AF

  There will be a 3 month blanking period after ablation during which recurrent atrial arrhythmias will not contribute to the primary endpoint.

  12 months after ablation

Secondary Outcomes (13)

• Time to recurrence of atrial fibrillation after a 3 month blanking period of ablation

  up to 1 year after after ablation

• Freedom from recurrent atrial arrhythmias at 1 year after ablation after the blanking period of 3 months

  6 months after ablation

• Freedom from recurrent atrial arrhythmias at 6 months after repeat ablation

  6 months after a repeated ablation

• Atrial Fibrillation Severity Score (AFSS)

  up to 12 months after ablation

• Percent change in weight at 3 months after ablation

  3 months after ablation

Study Arms (2)

Metformin

EXPERIMENTAL

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

Drug: Metformin; Behavioral: Recommendations for lifestyle modification.; Device: AliveCor

Standard of care

OTHER

Standard of care ablation with recommendations for lifestyle modification.

Behavioral: Recommendations for lifestyle modification.; Device: AliveCor

Interventions

Metformin 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.

Also known as: Glucophage

Metformin

Recommendations for lifestyle modification. 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.

Metformin; Standard of care

AliveCor 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.

Metformin; Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Metformin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Hakan Oral, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: January 19, 2021
• Primary Completion: July 1, 2025
• Study Completion: August 10, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)