Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF)
NCT ID: NCT03603912
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
175 participants
INTERVENTIONAL
2018-08-24
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Control
Written educational literature on healthy eating and exercise guideline
No interventions assigned to this group
Metformin
Metformin ER up to 750 mg twice daily
Metformin
Metformin ER 500 mg daily, titrated at 1 month intervals to 500 mg twice daily, then 750 mg twice daily, as tolerated, for 2 years.
Lifestyle/Risk Factor Modification
Lifestyle/Risk Factor Modification (LRFM): Diet/nutrition, exercise, and risk factor modification
Lifestyle/Risk Factor Modification
Diet/nutrition counseling and exercise prescription with follow-up visits, sleep apnea screening and treatment if detected, optimization of guideline-directed medical therapies for hypertension, coronary artery disease (CAD), hyperlipidemia and heart failure (HF).
Metformin + LRFM
Metformin ER up to 750 mg twice daily + Lifestyle/Risk Factor Modification (LRFM) diet/nutrition, exercise, and risk factor modification
Metformin
Metformin ER 500 mg daily, titrated at 1 month intervals to 500 mg twice daily, then 750 mg twice daily, as tolerated, for 2 years.
Lifestyle/Risk Factor Modification
Diet/nutrition counseling and exercise prescription with follow-up visits, sleep apnea screening and treatment if detected, optimization of guideline-directed medical therapies for hypertension, coronary artery disease (CAD), hyperlipidemia and heart failure (HF).
No Atrial Fibrillation
Written educational literature on healthy eating and exercise guideline
No interventions assigned to this group
Interventions
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Metformin
Metformin ER 500 mg daily, titrated at 1 month intervals to 500 mg twice daily, then 750 mg twice daily, as tolerated, for 2 years.
Lifestyle/Risk Factor Modification
Diet/nutrition counseling and exercise prescription with follow-up visits, sleep apnea screening and treatment if detected, optimization of guideline-directed medical therapies for hypertension, coronary artery disease (CAD), hyperlipidemia and heart failure (HF).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Paroxysmal AF, or persistent AF with plans for conversion.
3. AF on cardiac implantable electrical device (CIED) over the past 3 months with at least 1 episode lasting ≥5 minutes.
4. If on an antiarrhythmic drug, then on a stable regimen for the past 3 months.
1. Permanent pacemaker or ICD (with or without CRT) with an implanted atrial lead capable of providing AF diagnostics and remote monitoring.
2. No AF on CIED over the past 6 months.
3. No history of AF.
4. Age \>/=18 years old.
Exclusion Criteria
2. If in persistent AF, current episode \>12 months in duration (current long-standing persistent AF)
3. NYHA Functional Class IV heart failure
4. On metformin or other pharmacologic therapy for diabetes mellitus.
5. Use of anti-retroviral protease inhibitors (e.g. ombitasvir, paritaprevir, ritonavir, dasabuvir) or topiramate.
6. Known sensitivity to metformin
7. Moderate renal disease (eGFR \<45 ml/min/1.73 m2)
8. Significant alcohol use (average \>2 drinks/day)
9. Hepatic dysfunction - bilirubin \>1.5x ULN, unless due to Gilbert's syndrome
10. Planned antiarrhythmic (class I or III) drug change, AF ablation/PVI procedure or cardiac surgery over the first 3 mos of the study
11. AF ablation/PVI procedure performed in the past 6 months
12. Device changed or implanted in the past 3 months
13. For patients on dofetilide with a pacemaker, QTc \>490 ms if QRS duration is \</=100 ms. If QRS duration is \>100 ms, adjusted QTc \>490 ms. Adjusted QTc = QTc - (QRS duration - 100 ms).
14. Women who are pregnant, breast-feeding or of child-bearing potential and not willing or able to use an acceptable form of contraception.
15. Participants considered by the investigator to be unsuitable for the study for any of the following reasons: Not agreeable for treatment with metformin or anticipated to have poor compliance on study drug treatment; inability to follow diet or exercise instructions; unwilling to attend study follow-up visits
16. Life expectancy less than 2 years due to concomitant disease.
17. Age \<18 years old.
TRIM - No AF Cohort
1. History of AF.
2. NYHA Functional Class IV heart failure
3. On metformin or other pharmacologic therapy for diabetes mellitus.
4. Use of anti-retroviral protease inhibitors (e.g. ombitasvir, paritaprevir, ritonavir, dasabuvir) or topiramate.
5. Moderate renal disease (eGFR \<45 ml/min/1.73 m2)
6. Significant alcohol use (average \>2 drinks/day)
7. Hepatic dysfunction - bilirubin \>1.5x ULN, unless due to Gilbert's syndrome
8. Planned antiarrhythmic (class I or III) drug change, cardiac surgery over the first 3 mos of the study
9. Device changed or implanted in the past 3 months
10. For patients on dofetilide with a pacemaker, QTc \>490 ms if QRS duration is \</=100 ms. If QRS duration is \>100 ms, adjusted QTc \>490 ms. Adjusted QTc = QTc - (QRS duration - 100 ms).
11. Women who are pregnant, breast-feeding or of child-bearing potential and not willing or able to use an acceptable form of contraception.
12. Participants considered by the investigator to be unsuitable for the study for any of the following reasons: Not agreeable for treatment with metformin or anticipated to have poor compliance on study drug treatment; inability to follow diet or exercise instructions; unwilling to attend study follow-up visits
13. Life expectancy less than 2 years due to concomitant disease.
14. Age \<18 years old.
18 Years
ALL
No
Sponsors
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American Heart Association
OTHER
The Cleveland Clinic
OTHER
Mina Chung, MD
OTHER
Responsible Party
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Mina Chung, MD
Principal Investigator, Professor of Medicine
Principal Investigators
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Mina K Chung, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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References
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Wass SY, Barnard J, Kim HS, Sun H, Telfer W, Schilling T, Barzilai B, Bruemmer D, Cho L, Huang J, Hussein A, Kashyap SR, Laffin L, Mehra R, Moravec C, Saliba W, Sanders P, Nissen S, Varma N, Smith J, Van Wagoner D, Chung MK. Upstream targeting for the prevention of atrial fibrillation: Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF)-rationale and study design. J Interv Card Electrophysiol. 2025 Jan;68(1):9-19. doi: 10.1007/s10840-024-01955-z. Epub 2024 Dec 13.
Other Identifiers
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18-757
Identifier Type: -
Identifier Source: org_study_id
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