A Phase 2 interventional study of Metformin in Atrial Fibrillation, sponsored by The Guthrie Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by The Guthrie Clinic · Phase 2, Interventional, and Treatment
The purpose of this study is to see if the study drug metformin will help patients who are overweight and have atrial fibrillation. This study aims to see if metformin helps patients stay in normal sinus rhythm after a catheter ablation.
Metformin is investigational for use in patients with atrial fibrillation. Metformin is approved by the Food and Drug Administration (FDA) for use in patients with type 2 Diabetes Mellitus. Metformin is used with a proper diet and exercise program to control high blood sugar, and has been shown to help people lose weight. This study aims to look at the effects of metformin on weight loss and heart rhythm in patients with atrial fibrillation.
Enrollment: Consent, medical history, and dietary education. Randomization. treatment Metformin 500mg daily and increased as tolerated to 2000 mg daily over three weeks or control -no treatment. 6 weeks. Pre procedure safety labs, EKG, Atrial Fibrillation Severity Score survey, metformin held 48 hours prior to rhythm control procedure. Treatment resumed 48 hours post procedure or when renal function at baseline. Treatment plan for 6 months or discontinuation at any time they are found to meet the baseline exclusion criteria. Follow-up at 3 month and 6 month post procedure. Continuation of treatment at study completion determined by primary cardiologist or care provider.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 6 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →The Guthrie Clinic is the lead sponsor of 26 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation. Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks.
Drug: Metformin
Standard of care - ablation only
Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.
Number of Participants Who Maintain Sinus Rhythm
Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG)
Time frame: 6 months
Number of Participants Requiring Hospitalization
Hospitalization related to arrhythmic events or medication side effects
Time frame: 6 months
Number of Participants Requiring Antiarrhythmic Medications
Total count of participants on anti-arrhythmic medications
Time frame: 6 months
Number of Participants Requiring Repeat Ablations
Time frame: 6 months
Change in BMI
Average change in BMI from baseline to 6 month.
Time frame: Baseline to 6 months
Hemoglobin A1c
Change from baseline to 6 month
Time frame: Baseline to 6 months
Number of Participants With Thromboembolic Events
Number of participants who have a thromboembolic event from baseline to 6 months
Time frame: from baseline to 6 months
Weight Loss
Weight change from baseline to 6 months.
Time frame: baseline to 6 months
Study terminated prior to meeting enrollment target. Enrollment rate slower than expected.
| Milestone | Metformin Group | Control Group |
|---|---|---|
| Started | 2 | 4 |
| Completed | 2 | 4 |
| Not completed | 0 | 0 |
Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG)
| Participants | Metformin Group | Control Group |
|---|---|---|
| Number of Participants Who Maintain Sinus Rhythm | 1 | 0 |
Hospitalization related to arrhythmic events or medication side effects
| Participants | Metformin Group | Control Group |
|---|---|---|
| Number of Participants Requiring Hospitalization | 0 | 0 |
Total count of participants on anti-arrhythmic medications
| Participants | Metformin Group | Control Group |
|---|---|---|
| Number of Participants Requiring Antiarrhythmic Medications | 1 | 1 |
| Participants | Metformin Group | Control Group |
|---|---|---|
| Number of Participants Requiring Repeat Ablations | 0 | 0 |
Average change in BMI from baseline to 6 month.
| kg/m^2 | Metformin Group | Control Group |
|---|---|---|
| Change in BMI | 1.8 ± .8 | 1.7 ± 1.3 |
Change from baseline to 6 month
| percent glycosylated hemoglobin | Metformin Group | Control Group |
|---|---|---|
| Hemoglobin A1c | .1 ± .14 | .15 ± .1 |
Number of participants who have a thromboembolic event from baseline to 6 months
| Participants | Metformin Group | Control Group |
|---|---|---|
| Number of Participants With Thromboembolic Events | 0 | 0 |
Weight change from baseline to 6 months.
| pounds | Metformin Group | Control Group |
|---|---|---|
| Weight Loss | 2 ± 6.3 | -.6 ± 3.4 |
Collected over 6 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metformin Group | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Control Group | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Continuous(years) | Metformin Group | Control Group | Total |
|---|---|---|---|
| Mean | 69 ± 4 | 65 ± 3 | 66 ± 4 |
| Sex: Female, Male(Participants) | Metformin Group | Control Group | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 2 | 3 | 5 |
| Race and Ethnicity Not Collected(Participants) | Metformin Group | Control Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Metformin Group | Control Group | Total |
|---|---|---|---|
| United States | 2 | 4 | 6 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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