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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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 below
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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:
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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.
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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.
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I have severe heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 2 years for reporting.

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 more

Awards & Highlights

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.

Trial 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
1,057 Previous Clinical Trials
1,371,585 Total Patients Enrolled
22 Trials studying Atrial Fibrillation
5,392 Patients Enrolled for Atrial Fibrillation
Mina Chung, MDLead Sponsor
American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,012 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
92,063 Patients Enrolled for Atrial Fibrillation
Mina K Chung, MDPrincipal InvestigatorThe Cleveland Clinic
2 Previous Clinical Trials
1,328 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
1,300 Patients Enrolled for Atrial Fibrillation

Media Library

Lifestyle/Risk Factor Modification Clinical Trial Eligibility Overview. Trial Name: NCT03603912 — Phase 4
Atrial Fibrillation Research Study Groups: Lifestyle/Risk Factor Modification, Metformin, Control, No Atrial Fibrillation, Metformin + LRFM
Atrial Fibrillation Clinical Trial 2023: Lifestyle/Risk Factor Modification Highlights & Side Effects. Trial Name: NCT03603912 — Phase 4
Lifestyle/Risk Factor Modification 2023 Treatment Timeline for Medical Study. Trial Name: NCT03603912 — Phase 4
~15 spots leftby Aug 2025
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