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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Simvastatin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients randomized to active drug, then AF burden and CRP values will be compared to those in placebo arm. | Drug: Simvastatin<br>* Patients take 40 mg of simvastatin per day for 6 months.<br>* Other names: Zocor;|
| Placebo Comparator: 2<br>Patients take placebo once daily for 6 Months, then AF burden and CRP values will be compared to those in experimental arm. | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first detected AF |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in CRP and oxidative stress levels over time and their relationship with AF burden |  | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, statin therapy, CRP levels, Paroxysmal Atrial Fibrillation