PUFAs and Left Ventricular Function in Heart Failure

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Università degli Studi di Brescia

Criteria

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