Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation

• Status: Unknown status
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate that in patients with persistent atrial fibrillation who had recovered normal sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus rhythm at one year of follow up.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion GESICA

Criteria

Inclusion Criteria:

• Persistent atrial fibrillation

Exclusion Criteria:

• Contraindications or known hypersensitivity to n-3 PUFA

• Current treatment with n-3 PUFA for any reason

• Heart failure NYHA class IV

• Coronary artery bypass surgery or valve replacement within the past 3 months

• Planned cardiac procedures

• Known sick-sinus syndrome

• Diagnosis of Wolff-Parkinson-White

• Clinical significant valvular etiologies

• Presence of arrhythmia associated with an acute reversible condition

• Advanced chronic lung disease

• Contraindications for anticoagulation therapy

• Pregnancy or lactation

• Any non cardiac illness associated with a life expectancy of < 2 years

• Treatment with any investigational agent within 3 month before randomization

• Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol