The rationale and design of the FORomegaARD Trial: A randomized, double-blind, placebo-controlled, independent study to test the efficacy of n-3 PUFA for the maintenance of normal sinus rhythm in patients with previous atrial fibrillation.
BACKGROUND
Atrial fibrillation (AF) is associated with increased risk of death, thromboembolic complications, and a lowered quality of life. Despite this burden, pharmacologic agents for prevention of AF in patients who achieved normal sinus rhythm are of limited utility, mostly because of serious and frequent side effects. Thus, the availability of safer and more effective drugs may reduce the burden of disease.


METHODS
Patients aged > or =21 years with previous symptomatic AF and who have recovered normal sinus rhythm will be randomized to 1 g daily of omega-3-acid ethyl esters or identical placebo. To be included in the trial, patients must have either (a) at least 2 symptomatic episodes of documented AF in the 6 months before randomization, with the last episode occurring in the 14 to 90 days before randomization (paroxysmal AF), or (b) successful electrical or pharmacologic cardioversion for persistent AF. Ethical committees of 71 cardiology centers in 16 provinces of Argentina have qualified and approved the protocol and are expected to enroll 1,400 patients to test the primary end point of efficacy, which is survival free of AF during follow-up.


CONCLUSIONS
The Fish Oil Reserach with omega-3 for Atrial fibrillation Recurrence Delay (FORomegaARD) trial will determine whether pharmacologic supplementation with 1 g of omega-3-acid ethyl esters can reduce AF recurrence in patients with previous AF who have recovered normal sinus rhythm.
Macchia
Alejandro
A
Fundación Grupo de Estudio en Investigación Clínica en Argentina, Buenos Aires, Argentina. macchia@negrisud.it
Varini
Sergio
S
Grancelli
Hugo
H
Nul
Daniel
D
Laffaye
Nicolas
N
Ferrante
Daniel
D
Tognoni
Gianni
G
Doval
Hernan C
HC
D001118:Argentina; D001281:Atrial Fibrillation / Q000517:prevention & control*; D002985:Clinical Protocols; D004311:Double-Blind Method; D032984:Ethics, Research; D015525:Fatty Acids, Omega-3 / Q000494:pharmacology*; D006329:Heart Conduction System / Q000187:drug effects*; D006801:Humans; D012107:Research Design; D055502:Secondary Prevention
D015525:Fatty Acids, Omega-3