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 cardioversion

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004969-41-IT

Enrollment

266

Registered

2006-05-09

Start date

2006-02-14

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with persistent atrial fibrillation candidated to electrical cardioversion. MedDRA version: 6.1 Level: PT Classification code 10003658

Interventions

Trade Name: SEACOR 1000MG 20CPS Pharmaceutical Form: Capsule, soft INN or Proposed INN: Omega-3-triglycerides Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of EPA and DHA activity, in addition to usual antiarrhythmic therapy, on atrial fibrillation/flutter recurrence after electrical cardioversion of persistent atrial fibrillation.;Secondary Objective: 1-Evaluation of the treatment effect on electrical cardioversion. 2-Thromboembolic complications 3-Number of hospitalizations 4-PCR value measured by high sensitive method;Primary end point(s): Per cent of patients without any documented atrial fibrillation/flutter events to the end of follow-up	—

Measure

Time frame

Main Objective: Evaluation of EPA and DHA activity, in addition to usual antiarrhythmic therapy, on atrial fibrillation/flutter recurrence after electrical cardioversion of persistent atrial fibrillation.;Secondary Objective: 1-Evaluation of the treatment effect on electrical cardioversion. 2-Thromboembolic complications 3-Number of hospitalizations 4-PCR value measured by high sensitive method;Primary end point(s): Per cent of patients without any documented atrial fibrillation/flutter events to the end of follow-up

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026