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Recruitment issue: Enrollment expectation not met
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin Group | Experimental | 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. |
|
| Control Group | No Intervention | Standard of care - ablation only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Maintain Sinus Rhythm | Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Requiring Hospitalization | Hospitalization related to arrhythmic events or medication side effects | 6 months |
| Number of Participants Requiring Antiarrhythmic Medications |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Weight change from baseline to 6 months. | baseline to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Guthrie Clinic | Sayre | Pennsylvania | 18840 | United States |
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Study terminated prior to meeting enrollment target. Enrollment rate slower than expected.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin Group | 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. Metformin: 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. |
| FG001 | Control Group | Standard of care - ablation only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin Group | 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. Metformin: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Maintain Sinus Rhythm | Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG) | Posted | Count of Participants | Participants | 6 months |
|
6 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin Group | 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. Metformin: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pramod Deshmukh, MD | The Donald Guthrie Foundation for Education and Research | 570 887 2284 | Pramod.Deshmukh@guthrie.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2018 | Oct 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Total count of participants on anti-arrhythmic medications
| 6 months |
| Number of Participants Requiring Repeat Ablations | 6 months |
| Change in BMI | Average change in BMI from baseline to 6 month. | Baseline to 6 months |
| Hemoglobin A1c | Change from baseline to 6 month | Baseline to 6 months |
| Number of Participants With Thromboembolic Events | Number of participants who have a thromboembolic event from baseline to 6 months | from baseline to 6 months |
| BG001 | Control Group | Standard of care - ablation only |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Number of Participants Requiring Hospitalization | Hospitalization related to arrhythmic events or medication side effects | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants Requiring Antiarrhythmic Medications | Total count of participants on anti-arrhythmic medications | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants Requiring Repeat Ablations | Posted | Count of Participants | Participants | 6 months |
|
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| Secondary | Change in BMI | Average change in BMI from baseline to 6 month. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline to 6 months |
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| Secondary | Hemoglobin A1c | Change from baseline to 6 month | Posted | Mean | Standard Deviation | percent glycosylated hemoglobin | Baseline to 6 months |
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| Secondary | Number of Participants With Thromboembolic Events | Number of participants who have a thromboembolic event from baseline to 6 months | Posted | Count of Participants | Participants | from baseline to 6 months |
|
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| Other Pre-specified | Weight Loss | Weight change from baseline to 6 months. | Posted | Mean | Standard Deviation | pounds | baseline to 6 months |
|
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Control Group | Standard of care - ablation only | 0 | 4 | 0 | 4 | 0 | 4 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |