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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
Results First Received: April 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Atrial Fibrillation
Interventions: Drug: n-3 PUFAs
Drug: Placebo
Drug: RASS inhibitors and/or RAS blockers
Drug: Amiodarone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
n-3 PUFAs 1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
Placebo 1.0 g placebo gelatine capsules(olive oil)twice daily

Participant Flow:   Overall Study
    n-3 PUFAs     Placebo  
STARTED     100     99  
COMPLETED     94     94  
NOT COMPLETED     6     5  
Adverse Event                 2                 3  
spontaneous return to sinus rhythm                 4                 2  



  Baseline Characteristics
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Reporting Groups
  Description
n-3 PUFAs 1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
Placebo 1.0 g placebo gelatine capsules(olive oil)twice daily
Total Total of all reporting groups

Baseline Measures
    n-3 PUFAs     Placebo     Total  
Number of Participants  
[units: participants]
 		  100     99     199  
Age  
[units: years]
Mean ± Standard Deviation 		  70  ± 6     69  ± 9     69.6  ± 7.5  
Gender  
[units: partecipants]
 		     
Female     30     36     66  
Male     70     63     133  



  Outcome Measures

1.  Primary:   Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)   [ Time Frame: one year ]
  Show Outcome Measure 1

2.  Secondary:   The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence   [ Time Frame: 1, 3 and 6 months ]
Results not yet posted.   Anticipated Posting Date:   07/2011   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The effect of n-3 PUFAs on the recurrence of Atrial Fibrillation (AF) in patients with persistent AF not on amiodarone and a renin-angiotensin-aldosterone system (RASS) inhibitor cannot be inferred from our findings  


Results Point of Contact:  
Name/Title: Dr. Savina Nodari
Organization: Department of Experimental and Applied Medicine-Section of Cardiovascular Diseases
phone: 00390303996 ext 587
e-mail: nodari@med.unibs.it


No publications provided by Azienda Ospedaliera Spedali Civili di Brescia

Publications automatically indexed to this study:


Responsible Party: Savina Nodari, 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