Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF) (NCT03603912)
Upstream Targeting for the Prevention of Atrial Fibrillation: Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (36 items).
Location: Cleveland Clinic — Cleveland, Ohio
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Permanent AF with no plans to convert to sinus rhythm.
- If in persistent AF, current episode \>12 months in duration (current long-standing persistent AF)
- NYHA Functional Class IV heart failure
- On metformin or other pharmacologic therapy for diabetes mellitus.
- Use of anti-retroviral protease inhibitors (e.g. ombitasvir, paritaprevir, ritonavir, dasabuvir) or topiramate.
- Known sensitivity to metformin
- Moderate renal disease (eGFR \<45 ml/min/1.73 m2)
- Significant alcohol use (average \>2 drinks/day)
- Hepatic dysfunction - bilirubin \>1.5x ULN, unless due to Gilbert's syndrome
- Planned antiarrhythmic (class I or III) drug change, AF ablation/PVI procedure or cardiac surgery over the first 3 mos of the study
- AF ablation/PVI procedure performed in the past 6 months
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Cleveland Clinic — Cleveland, Ohio
📞 Contact the Study Coordinator
Phone: (866) 223-8100
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Atrial Fibrillation
- HeartBeam ECG Registry — Pittsburgh, Pennsylvania
- Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer — Portland, Oregon
- CHAMPION-AF Clinical Trial — Birmingham, Alabama
- Reversal of Atrial Substrate to Prevent Atrial — Calgary, Alberta
- Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation — Chicago, Illinois
- Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients — Rochester, New York
Explore by condition: All Atrial Fibrillation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.