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Sponsored by: |
Gruppo di Ricerca GISSI |
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Information provided by: | Gruppo di Ricerca GISSI |
ClinicalTrials.gov Identifier: | NCT00376272 |
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:
Condition | Intervention | Phase |
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Atrial Fibrillation |
Drug: Valsartan Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 1442 |
Study Start Date: | November 2004 |
Study Completion Date: | March 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental | Drug: Valsartan |
2: Placebo Comparator | Drug: Placebo |
The protocol is sponsored by an independent organization and partially supported by Novartis
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least one of the following underlying cardiovascular diseases/comorbidities:
Exclusion Criteria:
Study Chair: | Marcello Disertori, MD | Gruppo di Ricerca GISSI |
Study Chair: | Roberto Latini, MD | Gruppo di Ricerca GISSI |
Responsible Party: | Heart Care Foundation ( Aldo P. Maggioni ) |
Study ID Numbers: | G106 |
Study First Received: | September 12, 2006 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00376272 |
Health Authority: | Italy: Ministry of Health |
atrial fibrillation,atrial remodeling,dysrhythmias,valsartan |
Heart Diseases Ataxia-Telangiectasia Atrial Fibrillation Ataxia Telangiectasia |
Angiotensin II Valsartan Recurrence Arrhythmias, Cardiac |
Pathologic Processes Therapeutic Uses Vasoconstrictor Agents Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |