Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins (PAFRIOSIES)

The purpose of this study is to determine the effect of statin therapy for prevention of atrial fibrillation (AF) in pacemaker and non-pacemaker patients with paroxysmal atrial fibrillation in the absence of significant coronary artery disease.

Patients with a history of paroxysmal atrial fibrillation, with or without a dual chamber pacemaker and who meet all study criteria, will be randomized to receive either a placebo, or simvastatin 40 mg, daily for 6 months. Liver enzymes are drawn at randomization and 3 months. CRP and oxidative stress products are drawn at randomization, weekly for the first month and then monthly for 5 months. Patients transmit their rhythm, twice daily for 5 consecutive days at randomization, then 5 consecutive days monthly for 6 months. Clinic visits are required at randomization, 3 months and 6 months.

Patients randomized to active drug, then AF burden and CRP values will be compared to those in placebo arm.

Patients take placebo once daily for 6 Months, then AF burden and CRP values will be compared to those in experimental arm.

Inclusion Criteria: Patients with paroxysmal AF (> 3 epis each > 15 min in length) over 6 months Patients on stable antiarrhythmic drug therapy and life expectancy > 1 year Exclusion Criteria: Patients with PAF due to reversible cause Chronic inflammatory conditions Other medical conditions requiring statin therapy Patients on amiodarone or verapamil Elevated CK or ALT Life expectancy <1 year TAVN ablation Geographic isolation Inability to give informed consent