Status:
COMPLETED
GISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence
Lead Sponsor:
Gruppo di Ricerca GISSI
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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 a...
Detailed Description
The protocol is sponsored by an independent organization and partially supported by Novartis
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
1442 Patients enrolled
Trial Details
Trial ID
NCT00376272
Start Date
November 1 2004
End Date
March 1 2008
Last Update
April 20 2009
Active Locations (114)
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1
Ospedale Valdichiana Santa Margherita
Cortona, AR, Italy, 52040
2
Ospedale Cardinal Massaia
Asti, AT, Italy, 14100
3
Azienda Ospedaliera Giuseppe Moscati
Avellino, AV, Italy, 83100
4
Ospedale Consorziale Policlinico
Bari, BA, Italy, 70124