Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

Last updated: April 16, 2025
Sponsor: University of Michigan
Overall Status: Active - Not Recruiting

Phase

4

Condition

Chest Pain

Atrial Fibrillation

Dysrhythmia

Treatment

Recommendations for lifestyle modification.

Metformin

AliveCor

Clinical Study ID

NCT04625946
HUM00174848
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body Mass Index (BMI) >25 kilograms / square meter (kg/m2) with plan for rhythmcontrol of atrial fibrillation by catheter ablation

  • All subjects must be able to understand and willing to sign a written informedconsent document.

Exclusion

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 totaking metformin (estimated glomerular filtration rate (eGFR)<30 millilitres perminute (mL/min)/1.73 square meters (m2), hypersensitivity to metformin, acute orchronic metabolic acidosis)

  • Patients taking carbonic anhydrase inhibitors

  • eGFR below 30 mL/min per 1.73 m2 or other clinical diagnosis of advanced renaldisease

  • Acute or chronic metabolic acidosis (serum bicarbonate <22 milliequivalents perliter (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

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: Recommendations for lifestyle modification.
Phase: 4
Study Start date:
January 19, 2021
Estimated Completion Date:
July 01, 2025

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.