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GISSI Prevention






To evaluate whether in patients with previous atrial fibrillation (AF) episodes treated with the best recommended therapies the addition of valsartan, an angiotensin II type-1 receptor blocker (ARB), can prevent AF recurrence.
Co-primary end-points of the study are: a) Time to first recurrence of AF, b) Rate of patients with more than one AF episode.
Secondary end-points: total number of AF episodes; number of hospitalizations for CV reasons, number of all-cause hospitalizations, incidence of thromboembolic events, safety profile.

Study design
Prospective, multicenter, randomized, double blind, placebo controlled study. Male or female patients ≥ 40 years of age, in sinus rhythm, with at least two ECG documented episodes of symptomatic AF in the previous 6 months or after a successful cardioversion for AF performed between 14 days and 48 hours before randomization are centrally randomized in a 1:1 ratio to receive either valsartan or placebo.
Patients must have at least one of the following underlying cardiovascular diseases/comorbidities: heart failure/documented history of LV dysfunction (defined as an EF < 40%), history of hypertension ≥ 6 months with/without LVH, type II diabetes mellitus, documented history of stroke or peripheral vascular disease, documented history of coronary artery disease, lone atrial fibrillation with documented LA dilation.
Each patient has been provided with a transtelephonic monitoring tool and could activate the tool transmitting his/her 30sec ECG to both coordinating center and responsible physician in case of symptoms; he/she must send 30 sec ECG record each week.

Population randomised
The study was started in November 2004 and the recruitment was completed in January 2007, with the inclusion of 1442 patients from 114 Cardiology centers. The follow-up (mean 223 days, median 283 days) was concluded in December 2007.