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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Savina Nodari, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier:
NCT01198275
First received: September 9, 2010
Last updated: January 19, 2012
Last verified: January 2012

September 9, 2010
January 19, 2012
January 2006
May 2008   (final data collection date for primary outcome measure)
Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm) [ Time Frame: one year ] [ Designated as safety issue: No ]
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.
probability of atrial fibrillation recurrences [ Time Frame: one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01198275 on ClinicalTrials.gov Archive Site
The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
The mean time to a first recurrence of AF; and the rate of AF recurrence at 1, 3 and 6 months.
the mean of the time to a first recurrence of atrial fibrillation [ Time Frame: mean of the time to a first recurrence of atrial fibrillation and rates of relapses at 1 - 3 - 6 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation
N-3 Polyunsaturated Fatty Acids (n-3 PUFAs) in the Prevention of Atrial Fibrillation Recurrences After Electrical Cardioversion. A Prospective Randomized Study.

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Atrial Fibrillation
  • 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
    Other Name: OMACOR
  • Drug: Placebo
    1.0 g of olive oil,one capsule twice a day
    Other Name: Placebo
  • Drug: 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.
    Other Name: renin-angiotensin-aldosterone system inhibitor
  • Drug: 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.
    Other Name: Amiodarone
  • Active Comparator: n-3 PUFAs
    Interventions:
    • Drug: n-3 PUFAs
    • Drug: RASS inhibitors and/or RAS blockers
    • Drug: Amiodarone
  • Placebo Comparator: placebo
    Interventions:
    • Drug: Placebo
    • Drug: RASS inhibitors and/or RAS blockers
    • Drug: Amiodarone
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
199
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01198275
CS-PUFA-01
Yes
Savina Nodari, Azienda Ospedaliera Spedali Civili di Brescia
Azienda Ospedaliera Spedali Civili di Brescia
Not Provided
Principal Investigator: Savina Nodari, MD Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
Study Director: Livio Dei Cas, MD Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
Azienda Ospedaliera Spedali Civili di Brescia
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP