PUFAs and Left Ventricular Function in Heart Failure (CS-PUFA-02)

Università degli Studi di Brescia

Status and phase

Completed

Phase 3

Conditions

Heart Failure

Dilated Cardiomyopathy

Treatments

Drug: n-3 PUFAs

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01223703

CS-PUFA-02

Details and patient eligibility

About

The purpose of this study is to test the hypothesis that n-3 PUFAs improve left ventricular systolic function in patients with stable chronic HF secondary to nonischemic dilated cardiomyopathy (NICM).

Full description

The results of the GISSI-HF trial indicate that in patients with chronic HF on evidence-based medical therapy and New York Heart Association (NYHA) functional class II-IV, long term treatment with n-3 PUFAs 1 g daily reduces mortality and hospitalizations for cardiovascular reasons. Several potential mechanisms may underlie the beneficial effects of n-3 polyunsaturated fatty acids (PUFAs) in HF patients, including, but not limited to, antiarrhythmic, and hemodynamic actions. The current investigation was therefore designed to test the hypothesis that treatment with n-3 PUFAs improves LV systolic function expressed as EF in patients with stable chronic HF secondary to a nonischemic dilated cardiomyopathy (NICM). Additionally, we sought to determine if n-3 PUFAs also exert positive effects on LV diastolic function assessed by echocardiography; functional capacity assessed by cardiopulmonary stress testing (CPET); and New York Heart Association (NYHA) functional class.

Enrollment

133 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients with a diagnosis of non ischemic cardiomyopathy (the absence of coronary artery disease,defined as the absence of stenosis > 50%, was confirmed by angiography performed at the time of the diagnostic workup of the cardiomyopathy)
LV systolic dysfunction (defined as an EF < 45%)
Stable clinical conditions with minimal or no symptoms for at least three month
Evidence-based medical treatment at maximum tolerated target doses for at least six month

Exclusion criteria

presence of symptoms or evidence of CAD diagnosed through noninvasive tests;
peripheral arterial disease;
presence of congenital or primary valvular heart disease;
persistent atrial fibrillation;
inability to perform bicycle ergometry for noncardiac causes;
moderately to severely reduced functional capacity;
NYHA functional class IV;
poor acoustic windows limiting the ability to assess echocardiographic measurements;
chronic lung disease;
advanced renal disease (eGFR < 30 mL/min/1.73 m2);
advanced liver disease;
any disease limiting life expectancy to one year or less;
contraindications to study drugs;
concomitant participation in other research studies