Metformin as an Upstream Therapy in Atrial Fibrillation

Phase 2TerminatedNCT02931253

The Guthrie Clinic6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants Who Maintain Sinus Rhythm

Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG)

Time frame: 6 months

Secondary Outcomes

Number of Participants Requiring Hospitalization

Hospitalization related to arrhythmic events or medication side effects

Time frame: 6 months

Number of Participants Requiring Antiarrhythmic Medications

Total count of participants on anti-arrhythmic medications

Time frame: 6 months

Number of Participants Requiring Repeat Ablations

Time frame: 6 months

Change in BMI

Average change in BMI from baseline to 6 month.

Time frame: Baseline to 6 months

Hemoglobin A1c

Change from baseline to 6 month

Time frame: Baseline to 6 months

Number of Participants With Thromboembolic Events

Number of participants who have a thromboembolic event from baseline to 6 months

Time frame: from baseline to 6 months

Metformin as an Upstream Therapy in Atrial Fibrillation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes