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

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).

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

I have irregular heartbeats and plans to normalize it.

I have never had atrial fibrillation.

I am 18 years old or older.

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.

My current episode of atrial fibrillation has lasted more than 12 months.

I am taking medication for diabetes.

I am not taking any anti-retroviral protease inhibitors or topiramate.

My kidney function is reduced (eGFR <45).

I am under 18 years old.

I have severe heart failure.

Treatment Details

The 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.

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

Group V: No Atrial FibrillationActive Control1 Intervention