What side effects are associated with this type of intervention?

Common treatments for Atrial Fibrillation (AF) include beta blockers, mineralocorticoid receptor antagonists, and SGLT2 inhibitors. Beta blockers can cause side effects such as fatigue, dizziness, and bradycardia. Mineralocorticoid receptor antagonists, like spironolactone, may lead to hyperkalemia and gynecomastia. SGLT2 inhibitors, such as dapagliflozin, are associated with urinary tract infections, genital infections, and dehydration. Metformin, while primarily used for diabetes, is being studied for its potential benefits in AF and is known to cause gastrointestinal issues like diarrhea but generally has a favorable safety profile.

What prior FDA approvals exist?

FDA-approved treatments for Atrial Fibrillation primarily include antiarrhythmic drugs, anticoagulants, and rate control medications. While Metformin itself is not approved for AF, it is being studied for its potential benefits in reducing atrial arrhythmias due to its effects on insulin sensitivity and glucose production. Similar to Metformin, other drugs that manage diabetes, such as Dapagliflozin, have shown promise in reducing recurrent atrial arrhythmias in patients with type 2 diabetes. However, the primary FDA-approved treatments for AF focus on controlling heart rhythm and preventing stroke rather than targeting metabolic pathways.

What other types of research exist?

Promising novel alternatives to Metformin for Atrial Fibrillation patients include: 1) Dapagliflozin, which reduces the risk of recurrent atrial arrhythmias and improves heart failure outcomes. 2) Canagliflozin, which improves metabolic syndrome risk factors in type 2 diabetes patients. Both drugs are SGLT2 inhibitors and offer cardiovascular benefits alongside glucose control.

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Metformin for Atrial Fibrillation

Phase 4

Waitlist Available

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

Must not have

Individuals who are already taking metformin or other antidiabetic medications, including insulin

Known diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after ablation

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if metformin, a diabetes drug, can help reduce abnormal heart rhythms in patients with atrial fibrillation. By managing blood sugar and insulin response, metformin might lower the risk of these heart issues. Metformin has been shown to have various cardiovascular benefits, including a reduction in stroke, heart failure, and heart attacks.

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.

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.

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

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My BMI is over 25 and I plan to have a procedure to correct heart rhythm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently taking metformin or other medications for diabetes.

Select...

I have been diagnosed with diabetes.

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I am currently taking medication for fluid build-up.

Select...

My liver function tests are within normal limits.

Select...

I do not have allergies or conditions that prevent me from taking metformin.

Select...

My kidney function is severely reduced.

Select...

I have had severe heart failure in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after ablation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after ablation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after ablation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Freedom from recurrent atrial arrhythmias by 6 months after a single ablation to eliminate AF

Secondary study objectives

Atrial Fibrillation Severity Score (AFSS)

Atrial Fibrillation

Incidence of major procedural complications

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

AliveCor

2015

N/A

~270

0 / 8Eligibility criteria met

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.

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Who is running the clinical trial?

University of MichiganLead Sponsor

1,849 Previous Clinical Trials

6,431,370 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