IRB Study Number 18-757
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
Upstream Targeting for the Prevention of AF:Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF)
This study is being done to see if lifestyle changes (including diet, exercise and attention to cardiovascular risk factors) and/or a medication called metformin will help reduce atrial fibrillation (AF) from getting worse. Atrial fibrillation is a rapid, irregular rhythm in the upper chambers of the heart. Metformin is FDA approved for the treatment of type 2 diabetes mellitus and may have cardiovascular protective effects.
You will not be charged for the metformin drug and the nutrition/diet and exercise guidance visits. We will also cover the cost of parking for your study visits.
We will be collecting information from your pacemaker or defibrillator from the device company to track how much AF you have. We will also collect blood and information, such as questionnaires, at the beginning, 1 year and 2 year visits.
Inclusion Criteria
- Permanent pacemaker or ICD (with or without CRT) with an implanted atrial lead or electrode capable of providing AF diagnostics and remote monitoring
- Paroxysmal AF, or persistent AF with plans for conversion
- If on an antiarrhythmic drug, then on a stable dose for the past 3 months.
Exclusion Criteria
- Permanent Atrial Fibrillation
- On Metformin or other Diabetes medications
- History of Diabetes
