Status:
COMPLETED
GISSI-HF- Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic CHF
Lead Sponsor:
Gruppo di Ricerca GISSI
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
INTRODUCTION While pharmacological treatments specifically targeted to the cardio-circulatory system have been largely investigated, scanty controlled data are available concerning the role of dietary...
Detailed Description
The Protocol is sponsored by an independent organization and partially supported by: AstraZeneca, Società Prodotti antibiotici, Sigma Tau, Pfizer
Eligibility Criteria
Inclusion
- Clinical evidence of heart failure according to the European Society of Cardiology guidelines (New York Heart Association class II-IV) (32)
- Any left ventricular Ejection Fraction (EF) measured within 3 months from enrolment (if EF% \>40%, at least 1 hospital admission for Congestive Heart Failure(CHF) in the previous year)
- No age limits
- Any etiology
- Informed consent (obtained before any study specific procedure)
Exclusion
- COMMON EXCLUSION CRITERIA (R1=n-3 PUFA vs placebo and R2=rosuvastatin vs placebo):
- Acute Myocardial Infarction, unstable angina or revascularization procedure within 1 month;
- planned cardiac surgery, expected to be performed within 3 months;
- congenital or primary valvular etiology;
- known hypersensitivity to study treatments;
- 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;
- patients already on treatment with n-3 PUFA or statin for whom the prescription is confirmed.
- EXCLUSION CRITERIA FOR R2 (statin hypothesis):
- current serum creatinine level \>2.5 mg/dL;
- current ALT, AST level \>1.5 times the upper normal limit;
- current CPK upper normal limits.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
6975 Patients enrolled
Trial Details
Trial ID
NCT00336336
Start Date
August 1 2002
End Date
May 1 2008
Last Update
August 14 2015
Active Locations (337)
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1
Ospedale San Giovanni di Dio
Agrigento, AG, Italy, 92100
2
Ospedale Barone Lombardo
Canicattì, AG, Italy, 92024
3
Ospedale San Giacomo D'Altopasso
Licata, AG, Italy, 92027
4
Ospedale Civile
Acqui Terme, AL, Italy, 15011