GISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence
Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
Summary
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