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Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

NCT04625946Phase 4

Key facts

Status: Completed
Start: Jan 2021
Primary completion: Jul 2025
Countries: 1
Sponsor: University of Michigan
Modality: Small Molecules

Drugs: liquid metformin (Aspargo Labs)
Conditions: Atrial fibrillation (AFib)

Overview

Phase 4, randomised, open-label trial of liquid metformin (Aspargo Labs) in Atrial fibrillation (AFib) (2 arms), sponsored by University of Michigan. Primary endpoint: Freedom From Recurrent Atrial Arrhythmias Between 3 to 12 Months After a Single Ablation to Eliminate Atrial Fibrillation. Started Jan 2021; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Metformin
Metformin + Standard of care ablation + Lifestyle modification + AliveCor monitoring.
Standard of care
Standard of care ablation + Lifestyle modification + AliveCor monitoring.

Who it enrols

Overweight or obese patients (BMI > 25) planned for catheter ablation for atrial fibrillation, excluding those with known diabetes, prior metformin use, severe renal or hepatic impairment, or advanced heart failure.

Endpoints

Primary

Freedom From Recurrent Atrial Arrhythmias Between 3 to 12 Months After a Single Ablation to Eliminate Atrial Fibrillation12 months

Secondary

Median Time to Recurrence of Atrial Fibrillation After a 3 Month Blanking Period of Ablation1 year
Freedom From Recurrent Atrial Arrhythmias at 6 Months After Ablation After the Blanking Period of 3 Months6 months
Freedom From Recurrent Atrial Arrhythmias at 6 Months After Repeat Ablation6 months
Atrial Fibrillation Severity Score - Part C12 months
Change in Weight6 months
Change in Hemoglobin A1c12 months
Number of Participants With Major Procedural Complication30 days
Atrial Fibrillation Related Morbidity During Follow-up1 year

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