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Metformin + Lifestyle Changes for Atrial Fibrillation (TRIM-AF Trial)
Phase 4
Waitlist Available
Led By Mina K Chung, MD
Research Sponsored by Mina Chung, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Paroxysmal AF, or persistent AF with plans for conversion.
No history of AF.
Must not have
Women who are pregnant, breast-feeding or of child-bearing potential and not willing or able to use an acceptable form of contraception.
Permanent AF with no plans to convert to sinus rhythm.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year, 2 years
Awards & highlights
Summary
This trial is testing whether metformin and lifestyle/risk factor modification can help prevent atrial fibrillation in people with pacemakers or defibrillators.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Metformin may cause digestive issues like nausea and diarrhea, as well as a rare but serious condition called lactic acidosis. Lifestyle changes typically don't have side effects but could include muscle soreness from new exercise routines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have irregular heartbeats and plans to normalize it.
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I have never had atrial fibrillation.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, breastfeeding, or if capable of childbearing, I am willing to use contraception.
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I have permanent atrial fibrillation and no plans to change it.
Select...
My current episode of atrial fibrillation has lasted more than 12 months.
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I am taking medication for diabetes.
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I am not taking any anti-retroviral protease inhibitors or topiramate.
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My kidney function is reduced (eGFR <45).
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I am under 18 years old.
Select...
I have severe heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year, 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in AF burden
Secondary study objectives
%change in average AF time/day
AF ablation/pulmonary vein isolation (PVI) for increase in burden or persistent AF
AF density
+29 moreTrial Design
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
Written educational literature on healthy eating and exercise guideline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Find a Location
Who is running the clinical trial?
The Cleveland ClinicOTHER
1,045 Previous Clinical Trials
1,370,500 Total Patients Enrolled
22 Trials studying Atrial Fibrillation
5,392 Patients Enrolled for Atrial Fibrillation
Mina Chung, MDLead Sponsor
American Heart AssociationOTHER
343 Previous Clinical Trials
4,971,423 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
92,067 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, or if capable of childbearing, I am willing to use contraception.You have a pacemaker or ICD with certain features for monitoring heart function.You have not had atrial fibrillation recorded on your heart monitoring device in the past 6 months.I have permanent atrial fibrillation and no plans to change it.You drink more than two alcoholic drinks on average every day.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 scheduled for a heart rhythm treatment or surgery within the first 3 months of the study.I am willing and able to follow the study's treatment, diet, exercise plans, and attend all follow-up visits.I have irregular heartbeats and plans to normalize it.I have never had atrial fibrillation.You have a permanent pacemaker or an implantable cardioverter-defibrillator with certain features.I am under 18 years old.My bilirubin levels are high, but it's due to Gilbert's syndrome.I have severe heart failure.I am 18 years old or older.I have been on the same heart rhythm medication for the last 3 months.I had a procedure to correct my heart rhythm within the last 6 months.You have had at least one episode of atrial fibrillation (AF) lasting 5 minutes or longer in the past 3 months, as detected by a cardiac implantable electrical device.You have another health condition that is expected to significantly shorten your life.You are allergic to metformin.My heart's electrical activity measurements meet specific criteria due to my pacemaker and medication.
Research Study Groups:
This trial has the following groups:- Group 1: Lifestyle/Risk Factor Modification
- Group 2: Metformin
- Group 3: Control
- Group 4: No Atrial Fibrillation
- Group 5: Metformin + LRFM
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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