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Metformin as an Upstream Therapy in Atrial Fibrillation

This study is currently recruiting participants.
Verified May 2017 by The Guthrie Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT02931253
First Posted: October 13, 2016
Last Update Posted: May 5, 2017
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.
Information provided by (Responsible Party):
The Guthrie Clinic
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation Drug: Metformin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin as an Upstream Therapy in Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by The Guthrie Clinic:

Primary Outcome Measures:
  • Number of participants who maintain sinus rhythm [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Hospitalization [ Time Frame: 6 months ]
    Hospitalization related to arrhythmic events or medication side effects

  • Number of antiarrhythmic medications [ Time Frame: 6 months ]
  • Number of repeat ablations [ Time Frame: 6 months ]
  • BMI [ Time Frame: 6 months ]
  • Hemoglobin A1c [ Time Frame: 6 months ]
  • Number of thromboembolic events [ Time Frame: 6 months ]

Other Outcome Measures:
  • Weight Loss [ Time Frame: 6 months ]
    patients


Estimated Enrollment: 800
Actual Study Start Date: April 11, 2017
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin Group

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
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.
No Intervention: Control Group
Standard of care - ablation only

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
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): NCT02931253


Contacts
Contact: Pramod Deshmukh, MD 570-887- 2284 deshmukh_pramod@guthrie.org
Contact: Zachary Wolfe, MD 570-887- 2284 wolfe_zachary@guthrie.org

Locations
United States, Pennsylvania
The Guthrie Clinic Recruiting
Sayre, Pennsylvania, United States, 18840
Sponsors and Collaborators
The Guthrie Clinic
  More Information

Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT02931253     History of Changes
Other Study ID Numbers: 1602-01
First Submitted: October 7, 2016
First Posted: October 13, 2016
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs