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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug Metformin for atrial fibrillation?

Research suggests that Metformin, commonly used for type 2 diabetes, may have benefits like reducing inflammation and protecting the heart, which could help lower the risk of atrial fibrillation in diabetic patients. ^{1 2 3 4 5}

How does the drug metformin differ from other treatments for atrial fibrillation?

Metformin, primarily used for type 2 diabetes, is unique in its potential to reduce the risk of atrial fibrillation due to its anti-inflammatory and cardio-protective effects, which are not the primary focus of other diabetes medications like insulin or sulfonylureas. ^{1 2 3 4 5}

Research Team

Hakan Oral, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

New-Onset Atrial Fibrillation in Patients With Type 2 Diabetes Treated With Novel Glucose-Lowering Therapies. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Association between first-line monotherapy with metformin and the risk of atrial fibrillation (AMRAF) in patients with type 2 diabetes. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Thiazolidinediones and Risk of Atrial Fibrillation Among Patients with Diabetes and Coronary Disease. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of Sodium-Glucose Cotransporter 2 Inhibitors and Glucagon-like Peptide Receptor Agonists for Atrial Fibrillation in Type 2 Diabetes Mellitus: Systematic Review With Network Meta-analysis of Randomized Controlled Trials. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Medical therapies for prevention of cardiovascular and renal events in patients with atrial fibrillation and diabetes mellitus. [2022]