Metformin as an Upstream Therapy in Atrial Fibrillation

Phase 2

Terminated

Brief Summary: The purpose of this study is to see if the study drug metformin will help patients who are overweight and have atrial fibrillation. This study aims to see if metformin helps patients stay in normal sinus rhythm after a catheter ablation.

Metformin is investigational for use in patients with atrial fibrillation. Metformin is approved by the Food and Drug Administration (FDA) for use in patients with type 2 Diabetes Mellitus. Metformin is used with a proper diet and exercise program to control high blood sugar, and has been shown to help people lose weight. This study aims to look at the effects of metformin on weight loss and heart rhythm in patients with atrial fibrillation.

Detailed Description: Enrollment: Consent, medical history, and dietary education. Randomization. treatment Metformin 500mg daily and increased as tolerated to 2000 mg daily over three weeks or control -no treatment. 6 weeks. Pre procedure safety labs, EKG, Atrial Fibrillation Severity Score survey, metformin held 48 hours prior to rhythm control procedure. Treatment resumed 48 hours post procedure or when renal function at baseline. Treatment plan for 6 months or discontinuation at any time they are found to meet the baseline exclusion criteria. Follow-up at 3 month and 6 month post procedure. Continuation of treatment at study completion determined by primary cardiologist or care provider.

Recruitment & Eligibility

Inclusion Criteria

All individuals diagnosed with Atrial Fibrillation and choosing to undergo a rhythm control strategy at Robert Packer Hospital with a BMI ≥ 27 will be eligible for the study. 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, have a diagnosis of diabetes, have a known allergy or FDA-labeled contraindication to taking metformin, eGFR below 30 mL/min per 1.73 m2 or other clinical diagnosis of advanced renal disease,, have acute or chronic metabolic acidosis (serum bicarbonate <22 mEq/L), have a history of significant alcohol use (>2 drinks/day on average), have a history of hepatic dysfunction (serum bilirubin 1.5X greater than the upper limit of normal), have a history of New York Heart Association (NYHA) Class III or IV heart failure, or are pregnant will be excluded from the trial.

Arm && Interventions

Group	Intervention	Description
Metformin Group	Metformin	Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation. Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Maintain Sinus Rhythm	6 months	Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG)

Secondary Outcome Measures

Name	Time	Method
Number of Participants Requiring Hospitalization	6 months	Hospitalization related to arrhythmic events or medication side effects
Number of Participants Requiring Antiarrhythmic Medications	6 months	Total count of participants on anti-arrhythmic medications
Change in BMI	Baseline to 6 months	Average change in BMI from baseline to 6 month.
Number of Participants With Thromboembolic Events	from baseline to 6 months	Number of participants who have a thromboembolic event from baseline to 6 months
Number of Participants Requiring Repeat Ablations	6 months
Hemoglobin A1c	Baseline to 6 months	Change from baseline to 6 month