GISSI-HF- Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic CHF

The Protocol is sponsored by an independent organization and partially supported by: AstraZeneca, Società Prodotti antibiotici, Sigma Tau, Pfizer

Inclusion criteria

• 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 criteria

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.