Metformin as an Upstream Therapy in Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT02931253|
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : May 9, 2018
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 or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Metformin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metformin as an Upstream Therapy in Atrial Fibrillation|
|Actual Study Start Date :||April 11, 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
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.
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
- Number of participants who maintain sinus rhythm [ Time Frame: 6 months ]
- 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 ]
- Weight Loss [ Time Frame: 6 months ]patients
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931253
|Contact: Pramod Deshmukh, MD||570-887- 2284||Pramod.Deshmukh@guthrie.org|
|United States, Pennsylvania|
|The Guthrie Clinic||Recruiting|
|Sayre, Pennsylvania, United States, 18840|