Back to resultsMetformin as an Upstream Therapy in Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
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.
Sites / Locations
- The Guthrie Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Metformin Group
Control Group
Arm Description
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.
Standard of care - ablation only
Outcomes
Primary Outcome Measures
Number of Participants Who Maintain Sinus Rhythm
Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG)
Secondary Outcome Measures
Number of Participants Requiring Hospitalization
Hospitalization related to arrhythmic events or medication side effects
Number of Participants Requiring Antiarrhythmic Medications
Total count of participants on anti-arrhythmic medications
Number of Participants Requiring Repeat Ablations
Change in BMI
Average change in BMI from baseline to 6 month.
Hemoglobin A1c
Change from baseline to 6 month
Number of Participants With Thromboembolic Events
Number of participants who have a thromboembolic event from baseline to 6 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02931253
Brief Title
Metformin as an Upstream Therapy in Atrial Fibrillation
Official Title
Metformin as an Upstream Therapy in Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruitment issue: Enrollment expectation not met
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
July 10, 2018 (Actual)
Study Completion Date
July 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Guthrie Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard of care - ablation only
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Maintain Sinus Rhythm
Description
Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants Requiring Hospitalization
Description
Hospitalization related to arrhythmic events or medication side effects
Time Frame
6 months
Title
Number of Participants Requiring Antiarrhythmic Medications
Description
Total count of participants on anti-arrhythmic medications
Time Frame
6 months
Title
Number of Participants Requiring Repeat Ablations
Time Frame
6 months
Title
Change in BMI
Description
Average change in BMI from baseline to 6 month.
Time Frame
Baseline to 6 months
Title
Hemoglobin A1c
Description
Change from baseline to 6 month
Time Frame
Baseline to 6 months
Title
Number of Participants With Thromboembolic Events
Description
Number of participants who have a thromboembolic event from baseline to 6 months
Time Frame
from baseline to 6 months
Other Pre-specified Outcome Measures:
Title
Weight Loss
Description
Weight change from baseline to 6 months.
Time Frame
baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Guthrie Clinic
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Metformin as an Upstream Therapy in Atrial Fibrillation
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