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

NCT00336336 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6975

Last updated 2015-08-14

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Gruppo di Ricerca GISSI

    lead OTHER

Principal Investigators

  • Luigi Tavazzi, MD · Policlinico San Matteo di Pavia

  • Gianni Tognoni, MD · Consorzio Mario Negri Sud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2008-04-30
Completion
2008-05-31

Countries

  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00336336 on ClinicalTrials.gov