Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376272
Recruitment Status : Completed
First Posted : September 14, 2006
Last Update Posted : April 20, 2009
Sponsor:
Information provided by:
Gruppo di Ricerca GISSI

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Valsartan Drug: Placebo Phase 3

Detailed Description:
The protocol is sponsored by an independent organization and partially supported by Novartis
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1442 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1 Drug: Valsartan
Placebo Comparator: 2 Drug: Placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
  2. First recurrence of AF, [ Time Frame: time to first AF recurrence ]
  3. Rate of patients with more than one AF episode, [ Time Frame: end of follow-up ]

Secondary Outcome Measures :
  1. Number of AF episodes [ Time Frame: end of fw-up ]
  2. Number of hospitalizations for CV reasons [ Time Frame: end of fw-up ]
  3. Number of all-cause hospitalizations [ Time Frame: end of fw-up ]
  4. Incidence of thromboembolic events [ Time Frame: end of fw-up ]
  5. Number of patients who die or with non-fatal thromboembolic events [ Time Frame: end of fw-up ]
  6. Number of patients in sinus rhythm at the time of each study visit [ Time Frame: end of fw-up ]
  7. Number of patients in sinus rhythm who did not have any prior AF recurrence during the study [ Time Frame: end of fw-up ]
  8. Duration and characteristics (ventricular rate) of the first recurrence of AF. [ Time Frame: end of fw-up ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients >=40 years of age
  2. Sinus rhythm
  3. 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

  4. 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)
  5. Written informed consent to participate in the study prior to any study procedures

Exclusion Criteria:

  1. Need for a continuous treatment with ARBs for any clinical reasons
  2. Contraindications or known hypersensitivity to ARBs
  3. Persistent standing systolic blood pressure < 110 mmHg
  4. Recent (<6 weeks) acute myocardial infarction or bypass surgery, or percutaneous coronary intervention
  5. Clinically significant valvular etiologies
  6. Thyroid dysfunction
  7. Indication for pacemaker or ICD implant or for an ablative treatment, recent (<6 months) PM or ICD implant, previous ablative treatment
  8. Planned cardiac surgery, expected to be performed within 3 months
  9. Serum creatinine level above 2.5 mg/dL
  10. Significant liver disease
  11. Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception
  12. 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
  13. Presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy
  14. Treatment with any investigational agent within 1 month before randomization
  15. Currently decompensated heart failure
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376272


Locations
Show Show 114 study locations
Sponsors and Collaborators
Gruppo di Ricerca GISSI
Investigators
Layout table for investigator information
Study Chair: Marcello Disertori, MD Gruppo di Ricerca GISSI
Study Chair: Roberto Latini, MD Gruppo di Ricerca GISSI
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Aldo P. Maggioni, Heart Care Foundation
ClinicalTrials.gov Identifier: NCT00376272    
Other Study ID Numbers: G106
First Posted: September 14, 2006    Key Record Dates
Last Update Posted: April 20, 2009
Last Verified: April 2009
Keywords provided by Gruppo di Ricerca GISSI:
atrial fibrillation,atrial remodeling,dysrhythmias,valsartan
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Disease Attributes
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action