Heart Failure
Conditions
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 and metabolic approaches in the management/outcome of patients with heart failure. A large scale, randomized, clinical trial is proposed to test the effects of (a) n-3 PUFA and (b) a lipid lowering agent on top of the best recommended treatments for heart failure. STUDY DESIGN The GISSI-HF is a prospective, multicenter, randomized, double blind, placebo controlled study, with randomized allocation of patients with a clinical diagnosis of heart failure to: Randomization 1 (R1): n-3 PUFA 1 g daily vs corresponding placebo; Randomization 2 (R2): rosuvastatin 10 mg daily vs corresponding placebo. OBJECTIVES OF THE STUDY PRIMARY OBJECTIVES To demonstrate that, in patients with heart failure treated at the best of recommended therapies, long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than the corresponding placebo in the reduction of: * All-cause mortality * All-cause mortality or hospitalizations for cardiovascular reason OTHER END-POINT MEASURES OF EFFICACY To assess that long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than corresponding placebo in the reduction of: * Cardiovascular mortality * Cardiovascular mortality or hospitalizations for any reason * Sudden cardiac death * Hospitalizations for any reason * Hospitalizations for cardiovascular reasons * Hospitalizations for congestive heart failure * Myocardial infarction * Stroke
Detailed description
The Protocol is sponsored by an independent organization and partially supported by: AstraZeneca, Società Prodotti antibiotici, Sigma Tau, Pfizer
Interventions
Sponsors
Gruppo di Ricerca GISSI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | from enrollment to 1252 deaths in R2 arm |
| All cause mortality or hospitalizations for any reason | from enrollment to 1252 deaths |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular mortality or hospitalization for heart failure or for any reasons | from enrollment to 1252 deaths in R2 arm |
| Sudden cardiac death | from enrollment to 1252 deaths in R2 arm |
| Hospitalizations for any reasons | from enrollment to 1252 deaths in R2 arm |
| Hospitalization for Cardiovascular reasons | from enrollment to 1252 deaths in R2 arm |
| Hospitalization for congestive heart failure | from enrollment to 1252 deaths in R2 arm |
| Miocardial infarction | from enrollment to 1252 deaths in R2 arm |
| Stroke | from enrollment to 1252 deaths in R2 arm |
| Cardiovascular mortality | from enrollment to 1252 deaths in R2 arm |
Countries
Italy, Switzerland
Outcome results
None listed