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Protocol

Introduction

The therapy

The n-3 PUFA hypothesis

The statin hypothesis

Study design

Primary objectives

Other end-point measures of efficacy

Subgroup analysis

Mechanistic goals

Concomitant treatments

Sample size calculation

Main analyses

References
  Study design


According to the tradition of the GISSI studies, GISSI-HF will be a pragmatic trial, with broad selection criteria to mimic real clinical practice as much as possible. Since no special examinations or procedures are required for the trial, the economic impact on the National Health Service will be minimized and use of resources likely to be optimized. 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.