Metformin + Lifestyle Changes for Atrial Fibrillation
(TRIM-AF Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMina K Chung, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Mina Chung, MD

No Placebo Group

Prior Safety Data

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).

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

You have a pacemaker or ICD with certain features for monitoring heart function.

You have not had atrial fibrillation recorded on your heart monitoring device in the past 6 months.

I have irregular heartbeats and plans to normalize it.

See 5 more

Exclusion Criteria

I am not pregnant, breastfeeding, or if capable of childbearing, I am willing to use contraception.

I have permanent atrial fibrillation and no plans to change it.

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

See 14 more

Treatment Details

Interventions

Lifestyle/Risk Factor Modification (Behavioral Intervention)
Metformin (Anti-diabetic agent)

Trial OverviewThe TRIM-AF study tests if Metformin and lifestyle changes can help manage Atrial Fibrillation in patients with cardiac devices. Participants will either get Metformin up to 750 mg twice daily or undergo lifestyle modifications, decided randomly.

Participant Groups

5Treatment groups

Experimental Treatment

Active Control

Group I: Metformin + LRFMExperimental Treatment2 Interventions

Metformin ER up to 750 mg twice daily + Lifestyle/Risk Factor Modification (LRFM) diet/nutrition, exercise, and risk factor modification

Group II: MetforminExperimental Treatment1 Intervention

Metformin ER up to 750 mg twice daily

Group III: Lifestyle/Risk Factor ModificationExperimental Treatment1 Intervention

Lifestyle/Risk Factor Modification (LRFM): Diet/nutrition, exercise, and risk factor modification

Group IV: ControlActive Control1 Intervention

Written educational literature on healthy eating and exercise guideline