Status:
COMPLETED
PUFAs and Left Ventricular Function in Heart Failure
Lead Sponsor:
Università degli Studi di Brescia
Conditions:
Dilated Cardiomyopathy
Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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).
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT01223703
Start Date
November 1 2007
End Date
June 1 2009
Last Update
January 31 2012
Active Locations (1)
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1
Arrhytmias and Heart failure Unit-Spedali Civili Hospital
Brescia, Italy, 25100