NCT00336336

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

A Large Scale Clinical Trial Testing the Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic Congestive Heart Failure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,975 (actual)
• Sponsor: Gruppo di Ricerca GISSI · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	n-3 PUFA	1 g die per os
DRUG	Rosuvastatin	10 mg die per os
DRUG	Placebo	1 gram c. per os
DRUG	Placebo	10 mg c. per os

Timeline

• Start date: 2002-08-01
• Primary completion: 2008-04-01
• Completion: 2008-05-01
• First posted: 2006-06-13
• Last updated: 2015-08-14

Locations

337 sites across 2 countries: Italy, Switzerland