Atrial Fibrillation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMetformin
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.
Sponsors
The Guthrie Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All individuals diagnosed with Atrial Fibrillation and choosing to undergo a rhythm control strategy at Robert Packer Hospital with a BMI ≥ 27 will be eligible for the study. All subjects must be able to understand and willing to sign a written informed consent document.
Exclusion criteria
* Individuals who are already taking metformin or other antidiabetic medications including insulin, have a diagnosis of diabetes, have a known allergy or FDA-labeled contraindication to taking metformin, eGFR below 30 mL/min per 1.73 m2 or other clinical diagnosis of advanced renal disease,, have acute or chronic metabolic acidosis (serum bicarbonate \<22 mEq/L), have a history of significant alcohol use (\>2 drinks/day on average), have a history of hepatic dysfunction (serum bilirubin 1.5X greater than the upper limit of normal), have a history of New York Heart Association (NYHA) Class III or IV heart failure, or are pregnant will be excluded from the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Maintain Sinus Rhythm | 6 months | Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Hospitalization | 6 months | Hospitalization related to arrhythmic events or medication side effects |
| Number of Participants Requiring Antiarrhythmic Medications | 6 months | Total count of participants on anti-arrhythmic medications |
| Number of Participants Requiring Repeat Ablations | 6 months | — |
| Hemoglobin A1c | Baseline to 6 months | Change from baseline to 6 month |
| Number of Participants With Thromboembolic Events | from baseline to 6 months | Number of participants who have a thromboembolic event from baseline to 6 months |
| Change in BMI | Baseline to 6 months | Average change in BMI from baseline to 6 month. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | baseline to 6 months | Weight change from baseline to 6 months. |
Countries
United States
Participant flow
Recruitment details
Study terminated prior to meeting enrollment target. Enrollment rate slower than expected.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| Control Group Standard of care - ablation only | 4 |
| Total | 6 |
Baseline characteristics
| Characteristic | Control Group | Total | Metformin Group |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 3 | 66 years STANDARD_DEVIATION 4 | 69 years STANDARD_DEVIATION 4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 4 participants | 6 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 4 |
| other Total, other adverse events | 0 / 2 | 0 / 4 |
| serious Total, serious adverse events | 0 / 2 | 0 / 4 |
Outcome results
Primary
Number of Participants Who Maintain Sinus Rhythm
Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG)
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metformin Group | Number of Participants Who Maintain Sinus Rhythm | 1 Participants |
| Control Group | Number of Participants Who Maintain Sinus Rhythm | 0 Participants |
Secondary
Change in BMI
Average change in BMI from baseline to 6 month.
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metformin Group | Change in BMI | 1.8 kg/m^2 | Standard Deviation 0.8 |
| Control Group | Change in BMI | 1.7 kg/m^2 | Standard Deviation 1.3 |
Secondary
Hemoglobin A1c
Change from baseline to 6 month
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metformin Group | Hemoglobin A1c | .1 percent glycosylated hemoglobin | Standard Deviation 0.14 |
| Control Group | Hemoglobin A1c | .15 percent glycosylated hemoglobin | Standard Deviation 0.1 |
Secondary
Number of Participants Requiring Antiarrhythmic Medications
Total count of participants on anti-arrhythmic medications
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metformin Group | Number of Participants Requiring Antiarrhythmic Medications | 1 Participants |
| Control Group | Number of Participants Requiring Antiarrhythmic Medications | 1 Participants |
Secondary
Number of Participants Requiring Hospitalization
Hospitalization related to arrhythmic events or medication side effects
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metformin Group | Number of Participants Requiring Hospitalization | 0 Participants |
| Control Group | Number of Participants Requiring Hospitalization | 0 Participants |
Secondary
Number of Participants Requiring Repeat Ablations
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metformin Group | Number of Participants Requiring Repeat Ablations | 0 Participants |
| Control Group | Number of Participants Requiring Repeat Ablations | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metformin Group | Number of Participants With Thromboembolic Events | 0 Participants |
| Control Group | Number of Participants With Thromboembolic Events | 0 Participants |
Other Pre-specified
Weight Loss
Weight change from baseline to 6 months.
Time frame: baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metformin Group | Weight Loss | 2 pounds | Standard Deviation 6.3 |
| Control Group | Weight Loss | -.6 pounds | Standard Deviation 3.4 |