The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation - Full Text View

Sponsors and Collaborators:	Mayo Clinic Pfizer
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00579098

Purpose

To investigate whether statin therapy utilizing the drug Lipitor (atorvastatin) might be effective in preventing short-and long-term atrial fibrillation following a left atrial ablation procedure. We further hypothesize this reduction will result from diminished peri-procedural inflammation, which will be reflected in lower CRP values.

Condition	Intervention	Phase
Atrial Fibrillation Arrhythmia Inflammation Endothelial Dysfunction	Drug: Atorvistatin Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title:	Atorvastatin for Prevention of Atrial Fibrillation Recurrence Following Pulmonary Veins Isolation: A Double-Blind, Placebo-Controlled, Randomized Pilot Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation Statins

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Freedom from symptomatic atrial fibrillation at 3 months. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Freedom from atrial arrhythmia (as opposed to atrial fibrillation) recurrence irrespective of symptoms. [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Reduction in CRP, lipid levels, and incidence of endothelial dysfunction at 3 months. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Improvement in quality of life. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Measurement of healthcare resource utilization and costs. [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	125
Study Start Date:	December 2007
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
1: Active Comparator Lipitor (atorvastatin),80 mg daily for 90 days	Drug: Atorvistatin 80 mg daily for 90 days
2: Placebo Comparator Placebo once daily by mouth for 90 days.	Drug: Placebo Placebo, once daily for 90 days

Detailed Description:

Although pharmacologic therapy is the traditional mainstay of therapy for AF, curative therapy has recently become possible.

There is growing evidence that inflammation may be involved in the pathogenesis of AF. C-reactive protein (CRP), a sensitive marker of systemic inflammation, is increased in patients with AF compared with patients in sinus rhythm. Elevated CRP levels are associated with increased likelihood of new onset AF and with recurrence of AF after successful cardioversion. Clinical and basic laboratory evidence suggests that, in addition to being potent lipid-lowering agents, statins may also have anti-inflammatory properties and protective effect against AF.

125 eligible patients with AF, undergoing left atrial ablation, will be randomly assigned in a 1:1 ratio to receive daily 80 mg of atorvastatin or placebo in a double-blind fashion for 3 months after their ablation procedure.

Patients will have baseline lipids, CRP, endothelial function tests (PAT)and Quality of Life (QoL) surveys compared with testing at 3 months post ablation.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients > or = to 18 years of age
Clinically indicated left atrial ablation procedure for atrial fibrillation

Exclusion Criteria:

Exclusion criteria are known malignancy
Known inflammatory disease
Surgery or trauma or myocardial infarction in the previous month
Known contraindication to statin therapy
Elevated liver enzymes two times normal
Patients already receiving therapy with any statin, niacin or fibrates at the time of their randomization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579098

Contacts

Contact: Celeste M Koestler, RN	507-255-2200	koestler.celeste@mayo.edu
Contact: Diane M Batzel	507-538-7043	batzel.diane@mayo.edu

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Celeste Koestler, RN 507-255-2200 koestler.celeste@mayo.edu
Principal Investigator: Paul A Friedman, MD

Sponsors and Collaborators

Mayo Clinic

Pfizer

Investigators

Principal Investigator:

Paul A Friedman, MD

Mayo Clinic

More Information

Publications:

Aviles RJ, Martin DO, Apperson-Hansen C, Houghtaling PL, Rautaharju P, Kronmal RA, Tracy RP, Van Wagoner DR, Psaty BM, Lauer MS, Chung MK. Inflammation as a risk factor for atrial fibrillation. Circulation. 2003 Dec 16;108(24):3006-10. Epub 2003 Nov 17.

Malouf JF, Kanagala R, Al Atawi FO, Rosales AG, Davison DE, Murali NS, Tsang TS, Chandrasekaran K, Ammash NM, Friedman PA, Somers VK. High sensitivity C-reactive protein: a novel predictor for recurrence of atrial fibrillation after successful cardioversion. J Am Coll Cardiol. 2005 Oct 4;46(7):1284-7.

Patti G, Chello M, Candura D, Pasceri V, D'Ambrosio A, Covino E, Di Sciascio G. Randomized trial of atorvastatin for reduction of postoperative atrial fibrillation in patients undergoing cardiac surgery: results of the ARMYDA-3 (Atorvastatin for Reduction of MYocardial Dysrhythmia After cardiac surgery) study. Circulation. 2006 Oct 3;114(14):1455-61. Epub 2006 Sep 25.

Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41.

Responsible Party:	Mayo Clinic ( Dr. Paul Friedman )
Study ID Numbers:	07-005460
Study First Received:	December 18, 2007
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00579098 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Atrial Fibrillation
Arrhythmia
Pulmonary Vein Isolation

Left atrial catheter ablation
Inflammation
Endothelial dysfunction

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin

Recurrence
Inflammation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases

Atrial Fibrillation
Inflammation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on July 02, 2009