Study purpose The purpose of the study is to show that the addition of valsartan on top of established therapies can reduce the recurrence of atrial fibrillation in patients with a history of recent atrial fibrillation associated with cardiovascular diseases/comorbidities. Primary objective To demonstrate that, in patients with history of recent atrial fibrillation treated with the best recommended therapies, the addition of valsartan 320 mg is superior to placebo in reducing atrial fibrillation recurrence. Study design The GISSI-AF is a prospective, multicenter, randomized, double blind, placebo controlled study. Patients with a history of atrial fibrillation will be centrally randomized in a 1:1 ratio to receive either valsartan or placebo. GISSI-AF will be a pragmatic trial, with broad selection criteria to mimic real clinical practice as much as possible. Since no special examinations or procedures are required for the trial, the economic impact on the National Health Service will be minimized and use of resources likely to be optimized. The enrollment period will last 12 months. The patients will be followed up for 12 months from study entry All prescribed treatments for AF or for the underlying cardiovascular diseases, including ACE-inhibitors, amiodarone and betablockers, will be allowed: * patients should be on a stable treatment for at least one month * the current guideline for hypertension treatment should be applied * patients should not be started on ARBs during the study
The protocol is sponsored by an independent organization and partially supported by Novartis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,442
Ospedale Valdichiana Santa Margherita
Cortona, AR, Italy
Ospedale Cardinal Massaia
Asti, AT, Italy
Azienda Ospedaliera Giuseppe Moscati
Avellino, AV, Italy
Ospedale Consorziale Policlinico
Bari, BA, Italy
Ospedale di Venere
Bari - Carbonara, BA, Italy
Ospedali Riuniti di Bergamo
To demonstrate that, in patients with history of recent AF treated with the best recommended therapies, the addition of valsartan (titrated up to 320 mg daily) is superior to placebo in reducing over the whole follow-up:
Time frame: Time to first AF recurrence
First recurrence of AF,
Time frame: time to first AF recurrence
Rate of patients with more than one AF episode,
Time frame: end of follow-up
Number of AF episodes
Time frame: end of fw-up
Number of hospitalizations for CV reasons
Time frame: end of fw-up
Number of all-cause hospitalizations
Time frame: end of fw-up
Incidence of thromboembolic events
Time frame: end of fw-up
Number of patients who die or with non-fatal thromboembolic events
Time frame: end of fw-up
Number of patients in sinus rhythm at the time of each study visit
Time frame: end of fw-up
Number of patients in sinus rhythm who did not have any prior AF recurrence during the study
Time frame: end of fw-up
Duration and characteristics (ventricular rate) of the first recurrence of AF.
Time frame: end of fw-up
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Bergamo, BG, Italy
Ospedale di Bentivoglio
Bentivoglio, BO, Italy
Ospedale Maggiore
Bologna, BO, Italy
Ospedale Bellaria
Bologna, BO, Italy
Casa di Cura Poliambulanza
Brescia, BS, Italy
...and 104 more locations