Metformin + Lifestyle Changes for Atrial Fibrillation
(TRIM-AF Trial)
Trial Summary
What is the purpose of this trial?
Prospective randomized open-label blinded endpoint (PROBE) 2x2 factorial study of metformin extended release up to 750 mg BID and lifestyle and risk factor modification (LRFM) in CIED patients with at least 1 ≥5 minute episode of AF over the prior 3 months. Randomization will be stratified by pacemaker vs. ICD and rhythm at enrollment (sinus rhythm/atrial paced vs. AF).
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 must not be on metformin or certain other drugs like anti-retroviral protease inhibitors or topiramate. If you're on an antiarrhythmic drug, you should have been on a stable regimen for the past 3 months.
What data supports the effectiveness of the treatment Metformin + Lifestyle Changes for Atrial Fibrillation?
While there is no direct evidence from the provided research about Metformin and lifestyle changes specifically for atrial fibrillation, lifestyle modifications have been shown to help manage risk factors for cardiovascular diseases, which can be related to atrial fibrillation. Additionally, Metformin is commonly used to manage type 2 diabetes, which is a risk factor for cardiovascular issues.12345
Is Metformin safe for humans?
How does the treatment of Metformin combined with lifestyle changes for atrial fibrillation differ from other treatments?
This treatment is unique because it combines Metformin, a drug commonly used for type 2 diabetes, with lifestyle changes to address atrial fibrillation, a heart condition. The novelty lies in using a diabetes medication to potentially benefit heart health, alongside lifestyle modifications that have shown success in managing chronic diseases.1112131415
Research Team
Mina K Chung, MD
Principal Investigator
The Cleveland Clinic
Eligibility Criteria
This trial is for adults with a pacemaker or ICD who've had at least one episode of atrial fibrillation in the past 3 months. They should not be on diabetes medication, have moderate renal disease, significant alcohol use, or life expectancy less than 2 years. Pregnant women and those unable to follow study protocols are also excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive metformin extended release up to 750 mg twice daily and/or lifestyle and risk factor modification
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in AF burden and other health metrics
Treatment Details
Interventions
- Lifestyle/Risk Factor Modification
- Metformin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mina Chung, MD
Lead Sponsor
The Cleveland Clinic
Collaborator
American Heart Association
Collaborator