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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 therapy


Conventional medical therapy for patients with heart failure was for many decades the association of diuretics and digitalis glycosides. More recently ACE-inhibitors and betablockers have been demonstrated to be the most efficacious agents known for the treatment of left ventricular dysfunction and heart failure. Despite the availability of medical therapy to reduce symptoms and improve survival, evidence from clinical trials indicates that there remains considerable room for improvement in the management of this growing public health problem, being mortality nearly 10% per year in the best treated groups of the most recent randomized clinical trials.

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.