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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
  The n-3 PUFA hypothesis


The GISSI-Prevenzione trial showed that 3-year treatment with low-dose n-3 PUFA was associated with a significant total mortality reduction of 21% in patients who survived a recent MI (starting treatment within 3 months from symptom onset). A post-hoc analysis of the causes of death showed that, among all cardiac causes, the most affected by n-3 PUFA was sudden cardiac death. Other experimental, epidemiological, as well as small size human studies are consistent with these findings and support the hypothesis that n-3 PUFA can exert antiarrhythmic or antifibrillatory effects.

This can be relevant for heart failure patients because nearly half of the deaths of patients with symptomatic heart failure are classified as sudden cardiac deaths. A post-hoc analysis of the GISSI-Prevenzione trial showed that, in nearly postinfarction 2000 patients with LV dysfunction/failure enrolled in the trial, the effects of n-3 PUFA on all-cause and sudden mortality were similar to those observed in the total population of the trial.
Therefore, the hypothesis that n-3 PUFA can improve the outcome of patients with heart failure of any etiology and any level of left ventricular function merits to be formally tested.