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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
History of Changes
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
 Drug: n-3 PUFAs
Drug: Placebo
Drug: RASS inhibitors and/or RAS blockers
Drug: Amiodarone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: N-3 Polyunsaturated Fatty Acids (n-3 PUFAs) in the Prevention of Atrial Fibrillation Recurrences After Electrical Cardioversion. A Prospective Randomized Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera Spedali Civili di Brescia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 199
Study Start Date: January 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: n-3 PUFAs 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: 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
Placebo Comparator: placebo 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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198275

Locations
Italy
Arrhytmias and Heart failure Unit-Spedali Civili Hospital
Brescia, Italy, 25100
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Investigators
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
  More Information

Additional Information:
interview during American College of Cardiology 2010 convention  This link exits the ClinicalTrials.gov site

No publications provided by Azienda Ospedaliera Spedali Civili di Brescia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: 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 Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT01198275     History of Changes
Other Study ID Numbers: CS-PUFA-01
Study First Received: September 9, 2010
Results First Received: April 13, 2011
Last Updated: January 19, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Azienda Ospedaliera Spedali Civili di Brescia:
PUFA atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 16, 2013