Clinical trial NCT00321802: Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins
Official title: Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
statin therapy
CRP levels
Paroxysmal Atrial Fibrillation
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Canadian Institutes of Health Research (CIHR)
First posted: 2006-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Time to first detected AF
timeFrame: 6 Months
Secondary outcomes:
measure: Changes in CRP and oxidative stress levels over time and their relationship with AF burden
timeFrame: 6 Months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary, Foothills Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Anne M Gillis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Henry J Duff, MD
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: Derek V Exner, MD, MPH
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: Katherine Kavanagh, MD
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: L B Mitchell, MD
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: Robert S Sheldon, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: D G Wyse, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: George Veenhuyzen, MD
role: STUDY_DIRECTOR
References: