NCT02931253

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2 atrial-fibrillation

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

April 11, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2018

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 11, 2020

Completed
Last Updated

January 25, 2024

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

October 7, 2016

Results QC Date

October 8, 2019

Last Update Submit

January 23, 2024

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Maintain Sinus Rhythm

    Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG)

    6 months

Secondary Outcomes (6)

  • Number of Participants Requiring Hospitalization

    6 months

  • Number of Participants Requiring Antiarrhythmic Medications

    6 months

  • Number of Participants Requiring Repeat Ablations

    6 months

  • Change in BMI

    Baseline to 6 months

  • Hemoglobin A1c

    Baseline to 6 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Weight Loss

    baseline to 6 months

Study Arms (2)

Metformin Group

EXPERIMENTAL

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.

Drug: Metformin

Control Group

NO INTERVENTION

Standard of care - ablation only

Interventions

MetforminDRUG

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.

Metformin Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Guthrie Clinic

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Metformin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Pramod Deshmukh, MD
Organization
The Donald Guthrie Foundation for Education and Research
Pramod.Deshmukh@guthrie.org
570 887 2284

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 13, 2016

Study Start

April 11, 2017

Primary Completion

July 10, 2018

Study Completion

July 10, 2018

Last Updated

January 25, 2024

Results First Posted

June 11, 2020

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)