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

Phase 2

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Placebo; Drug: Simvastatin

• Registration Number: NCT00321802
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-03
• Study First Submitted QC: 2006-05-03
• Study First Posted: 2006-05-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2015-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Patients take placebo once daily for 6 Months, then AF burden and CRP values will be compared to those in experimental arm.
1	Simvastatin	Patients randomized to active drug, then AF burden and CRP values will be compared to those in placebo arm.

Primary Outcome Measures

Name	Time	Method
Time to first detected AF	6 Months

Secondary Outcome Measures

Name	Time	Method
Changes in CRP and oxidative stress levels over time and their relationship with AF burden	6 Months

Trial Locations

Locations (1)

University of Calgary, Foothills Hospital; 🇨🇦 Calgary, Alberta, Canada