Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation
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 Start (Actual) 19 January 2021
🗓️ Primary Completion (Estimated) August 2024
✅ Study Completion (Estimated) February 2025
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Ann Arbor, Michigan, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 November 2020
  • First Submitted that Met QC Criteria 6 November 2020
  • First Posted 12 November 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 January 2024
  • Last Update Posted 11 January 2024
  • Last Verified January 2024