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Metformin for Atrial Fibrillation

Phase 4
Recruiting
Led By Hakan Oral, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body Mass Index (BMI) >25 kilograms / square meter (kg/m2) with plan for rhythm control of atrial fibrillation by catheter ablation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after ablation
Awards & highlights

Study Summary

This trial is testing whether metformin, a diabetes drug, can help reduce atrial fibrillation in patients who are having an ablation.

Who is the study for?
This trial is for individuals with a BMI over 25 who are undergoing catheter ablation to manage atrial fibrillation. Participants must understand and agree to the study's terms. Those already on metformin or other diabetes drugs, with known diabetes, severe kidney issues, metabolic acidosis, heavy alcohol use, liver dysfunction, advanced heart failure or who are pregnant/nursing cannot join.Check my eligibility
What is being tested?
The trial tests if metformin can help prevent atrial fibrillation from coming back after an ablation procedure. Patients will either receive no additional treatment or be given metformin alongside standard lifestyle change education. They'll be monitored for up to a year post-ablation.See study design
What are the potential side effects?
Metformin may cause side effects like stomach upset, diarrhea, nausea and potential vitamin B12 deficiency over time. It's generally well-tolerated but can rarely lead to more serious conditions such as lactic acidosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is over 25 and I plan to have a procedure to correct heart rhythm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after ablation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after ablation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from recurrent atrial arrhythmias by 6 months after a single ablation to eliminate AF
Secondary outcome measures
Atrial Fibrillation Severity Score (AFSS)
Atrial Fibrillation
Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices
+8 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard of careExperimental Treatment2 Interventions
Standard of care ablation with recommendations for lifestyle modification.
Group II: MetforminExperimental Treatment3 Interventions
Standard of care ablation with recommendations for lifestyle modification and metformin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Atrial Fibrillation (AF) include rate control, rhythm control, and anticoagulation. Rate control medications, such as beta-blockers and calcium channel blockers, slow the heart rate to manage symptoms and improve heart function. Rhythm control involves antiarrhythmic drugs and procedures like cardioversion or catheter ablation to restore and maintain normal heart rhythm. Anticoagulants prevent stroke by reducing blood clot risk. Metformin, typically used for diabetes, is being studied for its potential to reduce AF recurrence post-ablation by improving insulin sensitivity and reducing inflammation. These treatments are crucial for managing symptoms, preventing complications, and enhancing the quality of life for AF patients.
Obesity and atrial fibrillation.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,812 Previous Clinical Trials
6,384,649 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
7,132 Patients Enrolled for Atrial Fibrillation
Hakan Oral, MDPrincipal Investigator - University of Michigan
University of Michigan C.S. Mott Children's Hospital, University of Michigan Health System, University of Michigan Hospital, Von Voigtlander Women's Hospital
Hacettepe University (Medical School)
University Of Mi Hosps (Residency)
4 Previous Clinical Trials
365 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
305 Patients Enrolled for Atrial Fibrillation

Media Library

Atrial Fibrillation Research Study Groups: Metformin, Standard of care
Atrial Fibrillation Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT04625946 — Phase 4
~4 spots leftby Aug 2024
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