Clinical Trial: GISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Prospective, Parallel Group, Placebo-Controlled, Multi-Center Study on the Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence

Brief 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

Detailed Summary: The protocol is sponsored by an independent organization and partially supported by Novartis
Sponsor: Gruppo di Ricerca GISSI

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

  • 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:
  • First recurrence of AF,
  • Rate of patients with more than one AF episode,


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • To assess that long term administration of valsartan is more effective than placebo in the reduction of:
  • Number of AF episodes
  • Number of hospitalizations for CV reasons
  • Number of all-cause hospitalizations
  • Incidence of thromboembolic events
  • Number of patients who die or with non-fatal thromboembolic events
  • To show that the long-term administration of valsartan has a favorable effect on the:
  • Number of patients in sinus rhythm at the time of each study visit
  • Number of patients in sinus rhythm who did not have any prior AF recurrence during the study
  • To evaluate duration and characteristics (ventricular rate) of the first recurrence of AF.


Information By: Gruppo di Ricerca GISSI

Dates:
Date Received: September 12, 2006
Date Started: November 2004
Date Completion:
Last Updated: April 17, 2009
Last Verified: April 2009