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Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04625946
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : January 11, 2024
Sponsor:
Information provided by (Responsible Party):
Hakan Oral, University of Michigan

Study Description
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Brief Summary:

This clinical trial is being done to determine if metformin, a drug which is normally used in diabetes, can reduce atrial fibrillation in patients who are having an ablation for atrial fibrillation (AF). Atrial fibrillation is an abnormal heart rhythm which research has shown is related in part to obesity and diabetes.

It is anticipated that the participants treated in the metformin arm will have greater freedom from recurrent atrial arrhythmias after ablation.

Eligible participants enrolled in the trial will be assigned to one of the treatment arms (no treatment or metformin) and have follow-up visits up to approximately 1 year after the ablation. Additionally, all patients will also receive education on lifestyle changes and exercise which are standard of care.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Metformin Behavioral: Recommendations for lifestyle modification. Device: AliveCor Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation
Actual Study Start Date : January 19, 2021
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Metformin
Standard of care ablation with recommendations for lifestyle modification and metformin.
 Drug: Metformin

Metformin immediate release will be initiated at 250 milligrams (mg) daily (orally), and increased as tolerated to 2000 mg daily over a four week period. If a patient is unable to tolerate a dose increase they will return to their last tolerated dose after omitting one days dosing. 0 to Six weeks after the initiation of drug the patient will undergo (standard of care) ablation with the intent of achieving rhythm control.

Participants will stay on the metformin 12 months after the ablation. In addition, all participants will receive education on lifestyle changes and exercise which are standard of care as well as have a discussion with their treating electrophysiologist and receive a handout.

Other Name: Glucophage

Behavioral: Recommendations for lifestyle modification.
All subjects will receive education on lifestyle changes and exercise which are standard of care. This will include discussion with their treating electrophysiologist and a handout.

Device: AliveCor
Device will be used in order to record an electrocardiogram during symptoms perceived to be AF. All patients will be instructed to transmit at least once per week.
Standard of care
Standard of care ablation with recommendations for lifestyle modification.
 Behavioral: Recommendations for lifestyle modification.
All subjects will receive education on lifestyle changes and exercise which are standard of care. This will include discussion with their treating electrophysiologist and a handout.

Device: AliveCor
Device will be used in order to record an electrocardiogram during symptoms perceived to be AF. All patients will be instructed to transmit at least once per week.


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from recurrent atrial arrhythmias by 6 months after a single ablation to eliminate AF [ Time Frame: 6 months after ablation ]
    There will be a 3 month blanking period after ablation during which recurrent atrial arrhythmias will not contribute to the primary endpoint.


Secondary Outcome Measures :
  1. Time to recurrence of atrial fibrillation after a 3 month blanking period of ablation [ Time Frame: up to 1 year after after ablation ]
  2. Freedom from recurrent atrial arrhythmias at 1 year after ablation after the blanking period of 3 months [ Time Frame: 1 year after ablation ]
  3. Freedom from recurrent atrial arrhythmias at 6 months after repeat ablation [ Time Frame: 6 months after a repeated ablation ]
  4. Atrial Fibrillation Severity Score (AFSS) [ Time Frame: up to 12 months after ablation ]
    There are a total of 19 questions (parts A,B, and C) in this questionnaire. This collects information regarding the participants atrial fibrillation. It includes seven questions for subjects to report severity of symptoms (i.e. palpitations, shortness of breath at rest/physical activity, exercise intolerance, fatigue at rest, and lightheadedness/dizziness, chest pain or pressure) on a Likert scale from 0 (subject did not have this symptom) to 5 (symptom bothers subject a great deal).

  5. Percent change in weight at 3 months after ablation [ Time Frame: 3 months after ablation ]
  6. Percent change in weight at 6 months after ablation [ Time Frame: 6 months after ablation ]
  7. Percent change in hemoglobin A1c at 6 months after ablation [ Time Frame: 6 months after ablation ]
  8. Percent change in hemoglobin A1C at 12 months after ablation [ Time Frame: 12 months after ablation ]
  9. Incidence of major procedural complications [ Time Frame: up to 30 days ]
    Complications include but are not limited to major bleeding, vascular injury, myocardial perforation, stroke, and mortality.

  10. Atrial Fibrillation related morbidity during follow-up [ Time Frame: up to approximately 1 year after ablation ]
    During follow-up visits information will be collected regarding Emergency department visits and hospital admissions due to AF, Transient Ischemic Attack (TIA)/cerebrovascular accident (CVA), and mortality. These will be collected as total numbers between groups.

  11. Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices [ Time Frame: 6 months after ablation ]
  12. Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices [ Time Frame: 1 year after ablation ]
  13. Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices [ Time Frame: 3 months after ablation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) >25 kilograms / square meter (kg/m2) with plan for rhythm control of atrial fibrillation by catheter ablation
  • 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
  • Known diabetes
  • Known allergy or Food and Drug Administration (FDA)-labeled contraindication to taking metformin (estimated glomerular filtration rate (eGFR)<30 millilitres per minute (mL/min)/1.73 square meters (m2), hypersensitivity to metformin, acute or chronic metabolic acidosis)
  • Patients taking carbonic anhydrase inhibitors
  • eGFR below 30 mL/min per 1.73 m2 or other clinical diagnosis of advanced renal disease
  • Acute or chronic metabolic acidosis (serum bicarbonate <22 milliequivalents per liter (mEq/L))
  • History of significant alcohol use (>2 drinks/day on average)
  • History of hepatic dysfunction (serum bilirubin 1.5 times greater than ULN)
  • History of New York Heart Association (NYHA) Class III or IV heart failure
  • Pregnancy or nursing
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625946


Contacts
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Contact: Sangeeta Lathkar-Pradham 734-232-5022 slathkar@umich.edu
Contact: Hakan Oral, MD 734-763-7141 oralh@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Saneeta Lathkar-Pradham    734-232-5022    slathkar@umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Hakan Oral, MD University of Michigan
More Information
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Responsible Party: Hakan Oral, Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT04625946    
Other Study ID Numbers: HUM00174848
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: January 11, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hakan Oral, University of Michigan:
ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs