Diabetes drug and healthy habits tested to stop irregular heartbeat
NCT ID NCT03603912
First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 2 times
Summary
This study tests whether the diabetes drug metformin, combined with lifestyle changes like diet and exercise, can reduce episodes of atrial fibrillation (an irregular heartbeat) in people with pacemakers or defibrillators. About 175 participants will take metformin or a placebo and receive lifestyle counseling for two years. The goal is to see if these approaches can lower the amount of time spent in atrial fibrillation and improve overall heart health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin (extended-release) and lifestyle/risk factor modification (diet, exercise, sleep apnea screening, and management of blood pressure, cholesterol, and heart failure)
- What this could lead to
- If successful, this could point toward a simple, low-cost way to reduce atrial fibrillation episodes and improve heart health without invasive procedures.
- What could go wrong
- This is a relatively small, early-phase 4 trial (175 participants) with an open-label design, so results may not apply broadly. Metformin can cause gastrointestinal side effects, and lifestyle changes require long-term commitment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
175 people
The number who actually took part.
- Started
-
Aug 2018
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
TRIM-AF Cohorts Inclusion Criteria: 1. Permanent pacemaker or implantable cardioverter-defibrillator (ICD) (with or without cardiac resynchronization therapy (CRT) with an implanted atrial lead capable of providing AF diagnostics and remote monitoring. 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. Exclusion Criteria: 1. Permanent AF with no plans to convert to sinus rhythm. 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 Inclusion Criteria: 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: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cleveland Clinic
Cleveland, Ohio, 44195, United States
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