Clinical trial NCT04625946: Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation
Official title: Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: ablation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 150
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Freedom from recurrent atrial arrhythmias by 6 months after a single ablation to eliminate AF
timeFrame: 6 months after ablation
Secondary outcomes:
measure: Time to recurrence of atrial fibrillation after a 3 month blanking period of ablation
timeFrame: up to 1 year after after ablation
measure: Freedom from recurrent atrial arrhythmias at 1 year after ablation after the blanking period of 3 months
timeFrame: 1 year after ablation
measure: Freedom from recurrent atrial arrhythmias at 6 months after repeat ablation
timeFrame: 6 months after a repeated ablation
measure: Atrial Fibrillation Severity Score (AFSS)
timeFrame: up to 12 months after ablation
measure: Percent change in weight at 3 months after ablation
timeFrame: 3 months after ablation
measure: Percent change in weight at 6 months after ablation
timeFrame: 6 months after ablation
measure: Percent change in hemoglobin A1c at 6 months after ablation
timeFrame: 6 months after ablation
measure: Percent change in hemoglobin A1C at 12 months after ablation
timeFrame: 12 months after ablation
measure: Incidence of major procedural complications
timeFrame: up to 30 days
measure: Atrial Fibrillation related morbidity during follow-up
timeFrame: up to approximately 1 year after ablation
measure: Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices
timeFrame: 6 months after ablation
measure: Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices
timeFrame: 1 year after ablation
measure: Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices
timeFrame: 3 months after ablation
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hakan Oral, MD
role: PRINCIPAL_INVESTIGATOR
References: