n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

N-3 Polyunsaturated Fatty Acids (n-3 PUFAs) in the Prevention of Atrial Fibrillation Recurrences After Electrical Cardioversion. A Prospective Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198275
• Other study ID #: CS-PUFA-01
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2010
• Last updated: January 19, 2012
• Start date: January 2006
• Est. completion date: May 2008

Study information

• Verified date: January 2012
• Source: Azienda Ospedaliera Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• n-3 PUFAs
1.0 g of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in the average ratio EPA/DHA of 0.19:1.5, one capsule twice a day
• Placebo
1.0 g of olive oil,one capsule twice a day
• RASS inhibitors and/or RAS blockers
Patients on ACE-Is or ARBs were continued on the same agent. In those who were not on therapy, an ACE-I or an ARB was started. In all patients, an effort was made to achieve the highest tolerated dose.
• Amiodarone
Patients on amiodarone were continued at a maintenance dose of 200 mg daily, whereas those who were not taking amiodarone were started at a dose of 400 mg daily for 1 week and then continued on a maintenance dose of 200 mg daily.

Locations

Country	Name	City	State
Italy	Arrhytmias and Heart failure Unit-Spedali Civili Hospital	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)	Sinus Rhythm maintenance means no Atrial Fibrillation recurrence at one-year follow up. Patients with successful electrical cardioversion (DCCV)underwent weekly clinical and electrocardiographic controls for the first three weeks following cardioversion. Subsequently, follow up visits with performance of clinical evaluation, ECG, and a 24-hour Holter monitoring were performed at 1, 3, 6 and 12 months after DCCV.	one year	No
Secondary	The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence	The mean time to a first recurrence of AF; and the rate of AF recurrence at 1, 3 and 6 months.	1, 3 and 6 months	No

External Links

•   interview during American College of Cardiology 2010 convention