Metformin as an Upstream Therapy in Atrial Fibrillation

NCT ID: NCT02931253

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-11
• Study Completion Date: 2018-07-10

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin Group

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.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.

Control Group

Standard of care - ablation only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Metformin

Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Guthrie Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Guthrie Clinic

Sayre, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1602-01

Identifier Type: -

Identifier Source: org_study_id