N-3 Polyunsaturated Fatty Acids (n-3 PUFAs) in the Prevention of Atrial Fibrillation Recurrences After Electrical Cardioversion. A Prospective Randomized Study.
Overview
- Phase
- Phase 3
- Intervention
- n-3 PUFAs
- Conditions
- Atrial Fibrillation
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Enrollment
- 199
- Locations
- 1
- Primary Endpoint
- Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Savina Nodari
N-3 Polyunsaturated Fatty Acids (n-3 PUFAs) in the Prevention of Atrial Fibrillation Recurrences After Electrical Cardioversion. A Prospective Randomized Study.
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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
Arms & Interventions
n-3 PUFAs
Intervention: n-3 PUFAs
n-3 PUFAs
Intervention: RASS inhibitors and/or RAS blockers
n-3 PUFAs
Intervention: Amiodarone
placebo
Intervention: Placebo
placebo
Intervention: RASS inhibitors and/or RAS blockers
placebo
Intervention: Amiodarone
Outcomes
Primary Outcomes
Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)
Time Frame: one year
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.
Secondary Outcomes
- The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence(1, 3 and 6 months)