The rationale and design of the FORωARD 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
Received 16 September 2008; accepted 31 October 2008. published online 09 January 2009.
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.
Trial Design
Patients aged ≥21 years with previous symptomatic AF and who have recovered normal sinus rhythm will be randomized to 1 g daily of ω-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.
Conclusion
The Fish Oil Reserach with ω-3 for Atrial fibrillation Recurrence Delay (FORωARD) trial will determine whether pharmacologic supplementation with 1 g of ω-3–acid ethyl esters can reduce AF recurrence in patients with previous AF who have recovered normal sinus rhythm.
aFundación GESICA (Grupo de Estudio en Investigación Clínica en Argentina), Buenos Aires, Argentina
bConsorzio Mario Negri Sud, Santa Maria Imbaro, Chieti, Italy
Reprint requests: Alejandro Macchia, Fundación GESICA, Av. Rivadavia 2358, 1 “4” – C1034ACP Buenos Aires, Argentina.
ABSTRACT