Who is sponsoring NCT01198275?

NCT01198275 is sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia.

What condition does NCT01198275 study?

NCT01198275 studies Atrial Fibrillation.

What drugs are being tested in NCT01198275?

Interventions: n-3 PUFAs, Placebo, RASS inhibitors and/or RAS blockers, Amiodarone.

What is the status of NCT01198275?

NCT01198275 is currently COMPLETED.

Last reviewed 2012-01-19 · How we verify

N-3 Polyunsaturated Fatty Acids (n-3 PUFAs) in the Prevention of Atrial Fibrillation Recurrences After Electrical Cardioversion. A Prospective Randomized Study.

NCT01198275 Phase 3 COMPLETED Results posted

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).

Details

Lead sponsor	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Phase	Phase 3
Status	COMPLETED
Enrolment	199
Start date	2006-01
Completion	2008-05

Conditions

Atrial Fibrillation

Interventions

n-3 PUFAs
Placebo
RASS inhibitors and/or RAS blockers
Amiodarone

Primary outcomes

Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm) — one year
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.

Countries

Italy