Metformin as an Upstream Therapy in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Metformin as an Upstream Therapy in Atrial Fibrillation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02931253
• Other study ID #: 1602-01
• Status: Terminated
• Phase: Phase 2
• Start date: April 11, 2017
• Est. completion date: July 10, 2018

Study information

• Verified date: March 2023
• Source: The Guthrie Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Enrollment: Consent, medical history, and dietary education. Randomization. treatment Metformin 500mg daily and increased as tolerated to 2000 mg daily over three weeks or control -no treatment. 6 weeks. Pre procedure safety labs, EKG, Atrial Fibrillation Severity Score survey, metformin held 48 hours prior to rhythm control procedure. Treatment resumed 48 hours post procedure or when renal function at baseline. Treatment plan for 6 months or discontinuation at any time they are found to meet the baseline exclusion criteria. Follow-up at 3 month and 6 month post procedure. Continuation of treatment at study completion determined by primary cardiologist or care provider.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 10, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United States	The Guthrie Clinic	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight Loss	Weight change from baseline to 6 months.	baseline to 6 months
Primary	Number of Participants Who Maintain Sinus Rhythm	Number of participants who maintain sinus rhythm, normal heart rhythm by electrocardiogram (ECG)	6 months
Secondary	Number of Participants Requiring Hospitalization	Hospitalization related to arrhythmic events or medication side effects	6 months
Secondary	Number of Participants Requiring Antiarrhythmic Medications	Total count of participants on anti-arrhythmic medications	6 months
Secondary	Number of Participants Requiring Repeat Ablations		6 months
Secondary	Change in BMI	Average change in BMI from baseline to 6 month.	Baseline to 6 months
Secondary	Hemoglobin A1c	Change from baseline to 6 month	Baseline to 6 months
Secondary	Number of Participants With Thromboembolic Events	Number of participants who have a thromboembolic event from baseline to 6 months	from baseline to 6 months