GISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence - Full Text View

Sponsored by:	Gruppo di Ricerca GISSI
Information provided by:	Gruppo di Ricerca GISSI
ClinicalTrials.gov Identifier:	NCT00376272

Purpose

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

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Valsartan Drug: Placebo	Phase III

Genetics Home Reference related topics: ataxia-telangiectasia Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Ataxia Telangiectasia

Drug Information available for: Valsartan Angiotensin II Angiotensin II, ile(5)-

U.S. FDA Resources

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

Further study details as provided by Gruppo di Ricerca GISSI:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
First recurrence of AF, [ Time Frame: time to first AF recurrence ] [ Designated as safety issue: Yes ]
Rate of patients with more than one AF episode, [ Time Frame: end of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of AF episodes [ Time Frame: end of fw-up ] [ Designated as safety issue: No ]
Number of hospitalizations for CV reasons [ Time Frame: end of fw-up ] [ Designated as safety issue: No ]
Number of all-cause hospitalizations [ Time Frame: end of fw-up ] [ Designated as safety issue: No ]
Incidence of thromboembolic events [ Time Frame: end of fw-up ] [ Designated as safety issue: No ]
Number of patients who die or with non-fatal thromboembolic events [ Time Frame: end of fw-up ] [ Designated as safety issue: No ]
Number of patients in sinus rhythm at the time of each study visit [ Time Frame: end of fw-up ] [ Designated as safety issue: No ]
Number of patients in sinus rhythm who did not have any prior AF recurrence during the study [ Time Frame: end of fw-up ] [ Designated as safety issue: No ]
Duration and characteristics (ventricular rate) of the first recurrence of AF. [ Time Frame: end of fw-up ] [ Designated as safety issue: No ]

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
1: Experimental	Drug: Valsartan
2: Placebo Comparator	Drug: Placebo

Detailed Description:

The protocol is sponsored by an independent organization and partially supported by Novartis

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients >=40 years of age
Sinus rhythm
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
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 (LA diameter >=45 mm for men and >=40 mm for women)
Written informed consent to participate in the study prior to any study procedures

Exclusion Criteria:

Need for a continuous treatment with ARBs for any clinical reasons
Contraindications or known hypersensitivity to ARBs
Persistent standing systolic blood pressure < 110 mmHg
Recent (<6 weeks) acute myocardial infarction or bypass surgery, or percutaneous coronary intervention
Clinically significant valvular etiologies
Thyroid dysfunction
Indication for pacemaker or ICD implant or for an ablative treatment, recent (<6 months) PM or ICD implant, previous ablative treatment
Planned cardiac surgery, expected to be performed within 3 months
Serum creatinine level above 2.5 mg/dL
Significant liver disease
Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception
Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol
Presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy
Treatment with any investigational agent within 1 month before randomization
Currently decompensated heart failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376272

Show 114 Study Locations

Sponsors and Collaborators

Gruppo di Ricerca GISSI

Investigators

Study Chair:	Marcello Disertori, MD	Gruppo di Ricerca GISSI
Study Chair:	Roberto Latini, MD	Gruppo di Ricerca GISSI

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

Disertori M, Latini R, Maggioni AP, Delise P, Di Pasquale G, Franzosi MG, Staszewsky L, Tognoni G; GISSI-AF Investigators. Rationale and design of the GISSI-Atrial Fibrillation Trial: a randomized, prospective, multicentre study on the use of valsartan, an angiotensin II AT1-receptor blocker, in the prevention of atrial fibrillation recurrence. J Cardiovasc Med (Hagerstown). 2006 Jan;7(1):29-38.

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

Keywords provided by Gruppo di Ricerca GISSI:

atrial fibrillation,atrial remodeling,dysrhythmias,valsartan

Study placed in the following topic categories:

Heart Diseases
Ataxia-Telangiectasia
Atrial Fibrillation
Ataxia Telangiectasia

Angiotensin II
Valsartan
Recurrence
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009