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Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Metformin

Recommendations for lifestyle modification.

AliveCor

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Metformin

Standard of care

Arm Description

Standard of care ablation with recommendations for lifestyle modification and metformin.

Standard of care ablation with recommendations for lifestyle modification.

Outcomes

Primary Outcome Measures

Freedom from recurrent atrial arrhythmias by 6 months after a single ablation to eliminate AF

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

Time to recurrence of atrial fibrillation after a 3 month blanking period of ablation

Freedom from recurrent atrial arrhythmias at 1 year after ablation after the blanking period of 3 months

Freedom from recurrent atrial arrhythmias at 6 months after repeat ablation

Atrial Fibrillation Severity Score (AFSS)

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).

Percent change in weight at 3 months after ablation

Percent change in weight at 6 months after ablation

Percent change in hemoglobin A1c at 6 months after ablation

Percent change in hemoglobin A1C at 12 months after ablation

Incidence of major procedural complications

Complications include but are not limited to major bleeding, vascular injury, myocardial perforation, stroke, and mortality.

Atrial Fibrillation related morbidity during follow-up

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.

Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices

Full Information

NCT ID

NCT04625946

First Posted

November 6, 2020

Last Updated

February 7, 2023

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT04625946

Brief Title

Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

Official Title

Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 19, 2021 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Experimental

Arm Description

Standard of care ablation with recommendations for lifestyle modification and metformin.

Arm Title

Standard of care

Arm Type

Other

Arm Description

Standard of care ablation with recommendations for lifestyle modification.

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Recommendations for lifestyle modification.

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

AliveCor

Intervention Description

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.

Primary Outcome Measure Information:

Title

Freedom from recurrent atrial arrhythmias by 6 months after a single ablation to eliminate AF

Description

There will be a 3 month blanking period after ablation during which recurrent atrial arrhythmias will not contribute to the primary endpoint.

Time Frame

6 months after ablation

Secondary Outcome Measure Information:

Title

Time to recurrence of atrial fibrillation after a 3 month blanking period of ablation

Time Frame

up to 1 year after after ablation

Title

Freedom from recurrent atrial arrhythmias at 1 year after ablation after the blanking period of 3 months

Time Frame

1 year after ablation

Title

Freedom from recurrent atrial arrhythmias at 6 months after repeat ablation

Time Frame

6 months after a repeated ablation

Title

Atrial Fibrillation Severity Score (AFSS)

Description

Time Frame

up to 12 months after ablation

Title

Percent change in weight at 3 months after ablation

Time Frame

3 months after ablation

Title

Percent change in weight at 6 months after ablation

Time Frame

6 months after ablation

Title

Percent change in hemoglobin A1c at 6 months after ablation

Time Frame

6 months after ablation

Title

Percent change in hemoglobin A1C at 12 months after ablation

Time Frame

12 months after ablation

Title

Incidence of major procedural complications

Description

Complications include but are not limited to major bleeding, vascular injury, myocardial perforation, stroke, and mortality.

Time Frame

up to 30 days

Title

Atrial Fibrillation related morbidity during follow-up

Description

Time Frame

up to approximately 1 year after ablation

Title

Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices

Time Frame

6 months after ablation

Title

Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices

Time Frame

1 year after ablation

Title

Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices

Time Frame

3 months after ablation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sangeeta Lathkar-Pradham

Phone

734-232-5022

slathkar@umich.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Hakan Oral, MD

Phone

734-763-7141

oralh@umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hakan Oral, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Saneeta Lathkar-Pradham

Phone

734-232-5022

slathkar@umich.edu

12. IPD Sharing Statement

Plan to Share IPD

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Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

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