Clinical trial NCT01198275: n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation
Official title: N-3 Polyunsaturated Fatty Acids (n-3 PUFAs) in the Prevention of Atrial Fibrillation Recurrences After Electrical Cardioversion. A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: PUFA atrial fibrillation
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus rhythm after electrical conversion in patients with persistent Atrial fibrillation (AF).

Detailed description: Atrial fibrillation (AF) is the most common sustained arrhythmia and represents an increasing burden on the healthcare system. Treatment of AF remains controversial. In patients on antiarrhythmic therapy, the one-year relapse rates of AF after cardioversion ranges from 44% to 77% at one year and amiodarone appears to the be the most effective in maintaining sinus rhythm.Over the last few years, a growing amount of evidences has supported the protective effects of n-3 PUFAs in preventing ventricular arrhythmias and reducing the risk of sudden cardiac death. Furthermore, in the last years, the interest for their possible beneficial role in AF prevention has been increasing.We hypothesized that the administration of n-3 PUFAs could reduce the AF recurrence rate more than amiodarone plus RAAS inhibitors in patients with persistent AF. Therefore the present study aims to evaluate the role of n-3 PUFAs in the prophylaxis of AF recurrences after DCCV in addition to amiodarone and RAS blockers therapy in patients with persistent AF.

Eligibility criteria: Inclusion Criteria:

* persistent Atrial Fibrillation (AF) lasting \> one month
* history of at least one AF relapse after previous electrical or Pharmacological cardioversion

Exclusion Criteria:

* left atrium size \> 6 cm
* severe valvulopathy
* myocardial infarction during the previous 6 months
* unstable angina
* NYHA heart failure class IV or hemodynamic instability
* cardiac surgery during the previous 3 months
* significant pulmonary thyroid and hepatic disease
* contraindications to treatment with amiodarone or RASS inhibitors
* chronic renal dysfunction
* QT \> 480 msec in the absence of bundle-branch block
* bradycardia \< 50 b/min
* diagnosis of paroxysmal AF
* hyperkalemia
* pregnancy
* any disease or other medical treatment that, in the opinion of the investigators, could interfere with the study.

Primary outcomes:
measure: Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)
timeFrame: one year
Secondary outcomes:
measure: The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence
timeFrame: 1, 3 and 6 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Arrhytmias and Heart failure Unit-Spedali Civili Hospital
Study officials:
affiliation: Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
name: Savina Nodari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
name: Livio Dei Cas, MD
role: STUDY_DIRECTOR
References:
citation: 1) Go AS, Hylek EM. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 285(18):2370-2375, 2001 2) Wolf PA, Mitchell JB. Impact of atrial fibrillation on mortality, stroke, and medical costs. Arch Intern Med.;158(3):229-234, 1998 3) de Denus S, Sanoski CA. Rate vs rhythm control in patients with atrial fibrillation: a meta-analysis. Arch Intern Med 165(3):258-262, 1998 4) Fuster V, Ryden LE. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation.Europace 8(9):651-745, 2006 5) Nichol G, McAlister F. Meta-analysis of randomised controlled trials of the effectiveness of antiarrhythmic agents at promoting sinus rhythm in patients with atrial fibrillation. Heart 87(6):535-543, 2002 6) Calo L, Bianconi L. N-3 Fatty acids for the prevention of atrial fibrillation after coronary artery bypass surgery: a randomized, controlled trial. J Am Coll Cardiol 45(10):1723-1728, 2005
citation: Nodari S, Triggiani M, Campia U, Manerba A, Milesi G, Cesana BM, Gheorghiade M, Dei Cas L. n-3 polyunsaturated fatty acids in the prevention of atrial fibrillation recurrences after electrical cardioversion: a prospective, randomized study. Circulation. 2011 Sep 6;124(10):1100-6. doi: 10.1161/CIRCULATIONAHA.111.022194. Epub 2011 Aug 15.