Clinical trial NCT02931253: Metformin as an Upstream Therapy in Atrial Fibrillation
Official title: Metformin as an Upstream Therapy in Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants Who Maintain Sinus Rhythm
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Requiring Hospitalization
timeFrame: 6 months
measure: Number of Participants Requiring Antiarrhythmic Medications
timeFrame: 6 months
measure: Number of Participants Requiring Repeat Ablations
timeFrame: 6 months
measure: Change in BMI
timeFrame: Baseline to 6 months
measure: Hemoglobin A1c
timeFrame: Baseline to 6 months
measure: Number of Participants With Thromboembolic Events
timeFrame: from baseline to 6 months
Other outcomes:
measure: Weight Loss
timeFrame: baseline to 6 months
Locations:
city: Sayre
country: United States
facility: The Guthrie Clinic
state: Pennsylvania
Study officials:
References: