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

University of Calgary

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: Simvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00321802

18108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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

Treatment:

Drug: Simvastatin

2

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo