n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation

PHASE3CompletedINTERVENTIONAL
Enrollment

199

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

Conditions
Atrial Fibrillation
Interventions
DRUG

n-3 PUFAs

1.0 g of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in the average ratio EPA/DHA of 0.19:1.5, one capsule twice a day

DRUG

Placebo

1.0 g of olive oil,one capsule twice a day

DRUG

RASS inhibitors and/or RAS blockers

Patients on ACE-Is or ARBs were continued on the same agent. In those who were not on therapy, an ACE-I or an ARB was started. In all patients, an effort was made to achieve the highest tolerated dose.

DRUG

Amiodarone

Patients on amiodarone were continued at a maintenance dose of 200 mg daily, whereas those who were not taking amiodarone were started at a dose of 400 mg daily for 1 week and then continued on a maintenance dose of 200 mg daily.

Trial Locations (1)

25100

Arrhytmias and Heart failure Unit-Spedali Civili Hospital, Brescia

All Listed Sponsors
lead

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

NCT01198275 - n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation | Biotech Hunter | Biotech Hunter