Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

University of Michigan

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04625946

HUM00174848

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

Metformin

Experimental group

Description:

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

Treatment:

Drug: Metformin

Device: AliveCor

Behavioral: Recommendations for lifestyle modification.

Standard of care

Other group

Description:

Standard of care ablation with recommendations for lifestyle modification.

Treatment:

Device: AliveCor

Behavioral: Recommendations for lifestyle modification.