Metformin for Atrial Fibrillation

Overseen By Hakan Oral, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Michigan

Must not be taking: Antidiabetics, Insulin, Carbonic anhydrase inhibitors

Disqualifiers: Diabetes, Advanced renal disease, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if metformin, a drug typically used for diabetes, can reduce atrial fibrillation (an irregular heart rhythm) in people undergoing ablation. Participants will be divided into two groups: one receiving metformin and the other receiving standard care, both with lifestyle advice. Researchers expect that those taking metformin will experience fewer irregular heartbeats after the procedure. Individuals with a BMI over 25 who are planning for ablation and not currently on diabetes medication might be suitable candidates. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking metformin or other antidiabetic medications.

What is the safety track record for metformin?

Research has shown that metformin is generally safe for people. This well-known drug primarily treats diabetes. Large studies have found that metformin is linked to a lower risk of developing atrial fibrillation (AF), a common heart rhythm issue, in people with diabetes.

Some individuals might experience an upset stomach or diarrhea while taking metformin, but these side effects are usually mild. Serious side effects are rare. Research suggests that using metformin for AF could help reduce heart rhythm problems without introducing major safety concerns. Since the FDA has already approved metformin for diabetes, its safety is well-established. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Metformin is unique because, while most treatments for atrial fibrillation, like ablation or antiarrhythmic drugs, focus directly on the heart's electrical system, metformin targets metabolic pathways that may influence heart rhythm indirectly. Researchers are excited about this treatment because metformin, primarily known as a diabetes medication, has the potential to improve heart health by reducing inflammation and oxidative stress, which are linked to atrial fibrillation. This novel approach could offer benefits beyond current treatments, potentially improving outcomes for patients with atrial fibrillation.

What evidence suggests that metformin might be an effective treatment for atrial fibrillation?

This trial will compare the effects of metformin with standard care for atrial fibrillation (AF). Studies have shown that metformin, a drug often used to treat diabetes, might also help lower the risk of AF, an irregular heartbeat. Research suggests that metformin improves factors related to AF, such as energy use and heart muscle function. One study found that people with diabetes who took metformin had a lower chance of developing AF compared to those using other diabetes medications. Another study found that metformin affects certain genes linked to AF, which might explain its role in reducing these irregular heartbeats. Overall, strong evidence suggests that metformin could effectively reduce the risk of atrial fibrillation. ^{1 2 3 5 6}

Who Is on the Research Team?

Hakan Oral, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

All subjects must be able to understand and willing to sign a written informed consent document.

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

Exclusion Criteria

You drink more than two alcoholic drinks every day on average.

I am currently taking medication for fluid build-up.

I am currently taking metformin or other medications for diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive catheter ablation and are assigned to either metformin or no treatment, with lifestyle modification education

3 months

1 visit (in-person) for ablation

Follow-up

Participants are monitored for safety and effectiveness, including atrial fibrillation severity and procedural complications

up to 12 months

Regular follow-up visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Metformin

Trial Overview 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.

How Is the Trial Designed?

Group I: Standard of care Experimental Treatment 2 Interventions

Standard of care ablation with recommendations for lifestyle modification.

Group II: Metformin Experimental Treatment 3 Interventions

Standard of care ablation with recommendations for lifestyle modification and metformin.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.120.009115?doi=10.1161/CIRCEP.120.009115

Metformin Is Associated With a Lower Risk of Atrial ... We found that patients on metformin monotherapy had significantly reduced risk of atrial arrhythmias, including atrial fibrillation, compared with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468145/

Metformin and Risk of New-Onset Atrial Fibrillation in Type 2 ... Metformin was associated with a statistically significantly lower risk of new-onset AF among patients with T2DM compared to other hypoglycemic ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666501824000989

Antiarrhythmic effects of metformin Experimental studies have shown that metformin improves metabolic, electrical, and histologic risk factors associated with AF and ventricular arrhythmias.

4. newsroom.clevelandclinic.org newsroom.clevelandclinic.org/2022/10/11/cleveland-clinic-researchers-identify-diabetes-drug-metformin-as-potential-atrial-fibrillation-treatment-in-collaborative-research

Cleveland Clinic Researchers Identify Diabetes Drug ... The analysis found metformin targeted 30 genes associated with atrial fibrillation, with direct effects on gene expression for eight.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05878535?term=AREA%5BBasicSearch%5D(Rate%20Control%20Efficacy%20in%20Permanent%20Atrial%20Fibrillation)&rank=7

NCT05878535 | METFORMIN FOR ATRIAL FIBRILLATION Metformin is being tested in the Targeting Aging with Metformin (TAME) trial [6] to develop effective next-generation drugs to increase healthspan and lifespan.

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.120.009115

Metformin Is Associated With a Lower Risk of Atrial ... We found that patients on metformin monotherapy had significantly reduced risk of atrial arrhythmias, including atrial fibrillation, ...