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

NCT00597220 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2011-06-22

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Omega 3 (n-3 PUFA)

1 gram of n-3 PUFA containing DHA and EPA

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Fundacion GESICA

    lead OTHER

Principal Investigators

  • Hernan C Doval, MD · Fundacion GESICA

  • Gianni Tognoni, MD · Mario Negri Institute

  • Hugo Grancelli, MD · Fundacion GESICA

  • Sergio Varini, MD · Fundacion GESICA

  • Daniel Nul, MD · Fundacion GESICA

  • Alejandro Macchia, MD · Fundacion GESICA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-07-31
Completion
2011-08-31

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00597220 on ClinicalTrials.gov