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Diabetes drug and healthy habits tested to stop irregular heartbeat

NCT ID NCT03603912

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.