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Metformin for Atrial Fibrillation

Phase 4

Recruiting

Led By Hakan Oral, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body Mass Index (BMI) >25 kilograms / square meter (kg/m2) with plan for rhythm control of atrial fibrillation by catheter ablation

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after ablation

Awards & highlights

Study Summary

This trial is testing whether metformin, a diabetes drug, can help reduce atrial fibrillation in patients who are having an ablation.

Who is the study for?

This trial is for individuals with a BMI over 25 who are undergoing catheter ablation to manage atrial fibrillation. Participants must understand and agree to the study's terms. Those already on metformin or other diabetes drugs, with known diabetes, severe kidney issues, metabolic acidosis, heavy alcohol use, liver dysfunction, advanced heart failure or who are pregnant/nursing cannot join.Check my eligibility

What is being tested?

The trial tests if metformin can help prevent atrial fibrillation from coming back after an ablation procedure. Patients will either receive no additional treatment or be given metformin alongside standard lifestyle change education. They'll be monitored for up to a year post-ablation.See study design

What are the potential side effects?

Metformin may cause side effects like stomach upset, diarrhea, nausea and potential vitamin B12 deficiency over time. It's generally well-tolerated but can rarely lead to more serious conditions such as lactic acidosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is over 25 and I plan to have a procedure to correct heart rhythm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after ablation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after ablation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after ablation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Atrial Fibrillation Severity Score (AFSS)

Atrial Fibrillation

Burden of Atrial Fibrillation assessed by AliveCOR Kardia Devices

+8 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Squamous cell carcinoma of the tongue

Femoral neck fracture

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of careExperimental Treatment2 Interventions

Standard of care ablation with recommendations for lifestyle modification.

Group II: MetforminExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,377,988 Total Patients Enrolled

11 Trials studying Atrial Fibrillation

7,132 Patients Enrolled for Atrial Fibrillation

Hakan Oral, MDPrincipal Investigator - University of Michigan

University of Michigan C.S. Mott Children's Hospital, University of Michigan Health System, University of Michigan Hospital, Von Voigtlander Women's Hospital

Hacettepe University (Medical School)

University Of Mi Hosps (Residency)

4 Previous Clinical Trials

365 Total Patients Enrolled

3 Trials studying Atrial Fibrillation

305 Patients Enrolled for Atrial Fibrillation

Media Library

Atrial Fibrillation Research Study Groups: Metformin, Standard of care

Atrial Fibrillation Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT04625946 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Metformin for consumer use?

"Our team at Power rates Metformin's safety as a 3 due to the fact that it is already approved, thus this trial being in Phase 4."

Answered by AI

Are there any historical precedents of Metformin being used in medical studies?

"Currently, the research into Metformin is substantial with 170 active studies and 43 in Phase 3. Pittsburgh, Pennsylvania has a large share of these trials; however, clinical sites from all across the United States are conducting investigations on this drug's efficacy."

Answered by AI

How many participants is this clinical trial enrolling?

"Affirmative. The details on clinicaltrials.gov indicate that this research endeavour is currently recruiting test subjects, commencing from the initial notification date of January 19th 2021 and most recently updated on January 17th 2022. This trial seeks to enrol 150 individuals at a single medical facility."

Answered by AI

Is there availability for those interested in participating in this clinical trial?

"Based on the information available through clinicaltrials.gov, this trial is currently recruiting participants. It was first posted on January 19th 2021 and has been revised most recently on January 17th 2022."

Answered by AI

In what type of health conditions is Metformin typically utilized?

"Metformin is a popular medication for treating physical exertion. However, it can also help manage type 1 diabetes mellitus, polycystic ovary syndrome and diabetic ketoacidosis in some cases."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

Hakan Oral 2021. "Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04625946.

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