Atrial FibrillationPhase 4NCT04625946
Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation
A Phase 4 study testing Metformin, Recommendations for lifestyle modification. and AliveCor in people with Atrial Fibrillation, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Metformin, Recommendations for lifestyle modification. and AliveCor
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to 10 Aug 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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))
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Metformin, Recommendations for lifestyle modification., AliveCor
- Keywords
- ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
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.
Recommendations for lifestyle modification.Behavioural
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.
AliveCorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Standard of care ablation with recommendations for lifestyle modification and metformin. Receives: Drug: Metformin; Behavioral: Recommendations for lifestyle modification.; Device: AliveCor |
| Standard of care | Other | Standard of care ablation with recommendations for lifestyle modification. Receives: Behavioral: Recommendations for lifestyle modification.; Device: AliveCor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Recurrent Atrial Arrhythmias Between 3 to 12 Months After a Single Ablation to Eliminate Atrial Fibrillation (AF)
Results reflect participants who did not experience a recurrent atrial arrhythmia between 3 to 12 months after receiving an ablation. There was a 3-month blanking period after ablation during which recurrent atrial arrhythmias did not contribute to the primary endpoint's results.
Measured: 12 months after ablation
Secondary outcomes (13)
Median Time to Recurrence of Atrial Fibrillation After a 3 Month Blanking Period of Ablation
Results reflect the median time in days for the recurrence of atrial fibrillation 3 months after ablation.
Measured: up to 1 year after ablation
Freedom From Recurrent Atrial Arrhythmias at 6 Months After Ablation After the Blanking Period of 3 Months
Results reflect participants who did not experience a recurrent atrial arrhythmia between 3 to 6 months after receiving an ablation. There was a 3-month blanking period after ablation during which recurrent atrial arrhythmias did not contribute to the secondary endpoint's results.
Measured: 3 to 6 months after ablation
Freedom From Recurrent Atrial Arrhythmias at 6 Months After Repeat Ablation
Results reflect participants who did not experience a recurrent atrial arrhythmia between 3 to 6 months after receiving a repeat ablation. There was a 3-month blanking period after ablation during which recurrent atrial arrhythmias did not contribute to the secondary endpoint's results.
Measured: 6 months after a repeated ablation
Atrial Fibrillation Severity Score (AFSS) - Part C
There were a total of 7 questions in this questionnaire. This collected information regarding the participants atrial fibrillation 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). The total range of the scale was 0 to 35, with 0 meaning no symptoms and 35 meaning maximum number of symptoms.
Measured: 12 months after ablation
Change in Weight at 3 Months After Ablation
Results reflect change in weight from baseline 3 months after ablation.
Measured: Baseline and 3 months after ablation
Change in Weight at 6 Months After Ablation
Results reflect change in weight from baseline 6 months after ablation.
Measured: Baseline and 6-months after ablation
Change in Hemoglobin A1c at 6 Months After Ablation
Results reflect change in A1c from baseline 6 months after ablation.
Measured: Baseline and 6-months after ablation
Change in Hemoglobin A1C at 12 Months After Ablation
Results reflect change in A1c from baseline 12 months after ablation.
Measured: Baseline and 12-months after ablation
Number of Participants With Major Procedural Complication up to 30 Days Post-Ablation
Results reflect number of participants who experienced a major procedural complication following ablation. Complications included but were not limited to major bleeding, vascular injury, myocardial perforation, stroke, and mortality.
Measured: up to 30 days
Atrial Fibrillation Related Morbidity During Follow-up
During follow-up visits information was collected regarding Emergency department visits and hospital admissions due to Atrial Fibrillation, Transient Ischemic Attack (TIA)/cerebrovascular accident (CVA), and mortality. These were collected as total number of participants who experienced one of these events.
Measured: up to approximately 1 year after ablation
Burden of Atrial Fibrillation Assessed by AliveCOR Kardia Devices
Results reflect the percentage of days during which some form of electrocardiographic monitoring demonstrated atrial fibrillation.
Measured: 3 months after ablation
Burden of Atrial Fibrillation Assessed by AliveCOR Kardia Devices, EKGs, Event Monitoring, Cardiac Implantable Electronic Devices
Results reflect the percentage of days during which some form of electrocardiographic monitoring demonstrated atrial fibrillation.
Measured: 6 months after ablation
Burden of Atrial Fibrillation Assessed by AliveCOR Kardia Devices
Results reflect the percentage of days during which some form of electrocardiographic monitoring demonstrated atrial fibrillation.
Measured: 1 year after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start19 Jan 2021
- Primary completion1 Jul 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Oral, University of Michigan
- Investigators
- Hakan Oral, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625946
- Sponsor's protocol ID
- HUM00174848
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2020
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No