A double-blind, controlled vs placebo trial to evaluate the efficacy of EPA and DHA ethyl esters, in addition to usual antiarrhythmic therapy, in the manintenance of synus rythm in patients candidate to electrical cardioversion of persistent atrial fibrillation. - EPA and DHA in FA after electrical cardioversio
- Conditions
- Patients with persistent atrial fibrillation candidated to electrical cardioversion.MedDRA version: 6.1Level: PTClassification code 10003658
- Registration Number
- EUCTR2005-004969-41-IT
- Lead Sponsor
- SOCIETA PRODOTTI ANTIBIOTICI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 266
1. Age 18 years 2. Persistent atrial fibrillation diagnosis moe than 7 days 3. Indication for planned electric cardioversion conventional way or TOE guided .
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Clinical instability 2. Non effectively treated hyperthyroidism 3. IMA within 1 month 4. Cardiosurgery within 1 month 5. Severe anaemia 6. Pericarditis or myocarditis 7. Pulmonary embolism or other pulmonary diseases 8. Non effectively treated cardiac failure NYHA IV 9. Ipokaliemia 10.EPA and DHA treatment during 3 months previous trial beginning / need of EPA and DHA treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method