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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


Heart failure is a complex clinical syndrome, as it is the final common pathway for several types of cardiac damage. During the past 3 decades there have been major advances in the prevention and treatment of cardiovascular diseases, as evidenced by major declines in mortality rates from acute myocardial infarction and stroke in the US and other Westernized societies. However, despite these advances, the incidence and prevalence of heart failure are still increasing.

This clinical condition represents a major public health problem with a significant impact on the healthcare system, being one of the most common hospital admitting diagnoses. The direct cost of heart failure to the European National Health Services represents nearly 1.5-2% of all expenditures. With an aging population, the burden of heart failure on society and the healthcare system is expected to continue to increase.

Heart failure is associated with significant mortality and morbidity. In real world clinical practice, the five-year mortality rate has been estimated to be at least 50%, however patients with severe heart failure may have a mortality rate approaching 50% in 1 year.