Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04625946
• Other study ID #: HUM00174848
• Status: Recruiting
• Phase: Phase 4
• Start date: January 19, 2021
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: Sangeeta Lathkar-Pradham
• Phone: 734-232-5022
• Email: slathkar[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Metformin
Metformin immediate release will be initiated at 250 milligrams (mg) daily (orally), and increased as tolerated to 2000 mg daily over a four week period. If a patient is unable to tolerate a dose increase they will return to their last tolerated dose after omitting one days dosing. 0 to Six weeks after the initiation of drug the patient will undergo (standard of care) ablation with the intent of achieving rhythm control. Participants will stay on the metformin 12 months after the ablation. In addition, all participants will receive education on lifestyle changes and exercise which are standard of care as well as have a discussion with their treating electrophysiologist and receive a handout.

Behavioral:
• Recommendations for lifestyle modification.
All subjects will receive education on lifestyle changes and exercise which are standard of care. This will include discussion with their treating electrophysiologist and a handout.

Device:
• AliveCor
Device will be used in order to record an electrocardiogram during symptoms perceived to be AF. All patients will be instructed to transmit at least once per week.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from recurrent atrial arrhythmias by 6 months after a single ablation to eliminate AF	There will be a 3 month blanking period after ablation during which recurrent atrial arrhythmias will not contribute to the primary endpoint.	6 months after ablation
Secondary	Time to recurrence of atrial fibrillation after a 3 month blanking period of ablation		up to 1 year after after ablation
Secondary	Freedom from recurrent atrial arrhythmias at 1 year after ablation after the blanking period of 3 months		1 year after ablation
Secondary	Freedom from recurrent atrial arrhythmias at 6 months after repeat ablation		6 months after a repeated ablation
Secondary	Atrial Fibrillation Severity Score (AFSS)	There are a total of 19 questions (parts A,B, and C) in this questionnaire. This collects information regarding the participants atrial fibrillation. It includes seven questions for subjects to report severity of symptoms (i.e. palpitations, shortness of breath at rest/physical activity, exercise intolerance, fatigue at rest, and lightheadedness/dizziness, chest pain or pressure) on a Likert scale from 0 (subject did not have this symptom) to 5 (symptom bothers subject a great deal).	up to 12 months after ablation
Secondary	Percent change in weight at 3 months after ablation		3 months after ablation
Secondary	Percent change in weight at 6 months after ablation		6 months after ablation
Secondary	Percent change in hemoglobin A1c at 6 months after ablation		6 months after ablation
Secondary	Percent change in hemoglobin A1C at 12 months after ablation		12 months after ablation
Secondary	Incidence of major procedural complications	Complications include but are not limited to major bleeding, vascular injury, myocardial perforation, stroke, and mortality.	up to 30 days
Secondary	Atrial Fibrillation related morbidity during follow-up	During follow-up visits information will be collected regarding Emergency department visits and hospital admissions due to AF, Transient Ischemic Attack (TIA)/cerebrovascular accident (CVA), and mortality. These will be collected as total numbers between groups.	up to approximately 1 year after ablation
Secondary	Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices		6 months after ablation
Secondary	Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices		1 year after ablation
Secondary	Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices		3 months after ablation