OMEGA-3-POLYUNSATURATED FATTY-ACIDS (n3-PUFA) IN PATIENTS WITH SEVERE CHRONIC HEART FAILURE: EFFECTS ON ENDOTHELIAL FUNCTION, LEFT VENTRICULAR REMODELLING, NATRIURETIC PEPTIDE LEVELS, AND EXERCISE CAPACITY
- Conditions
- chronic heart failure
- Registration Number
- EUCTR2005-000778-31-AT
- Lead Sponsor
- Dept. of Cardiology, Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 145
chronic heart failure of non-ischemic origin
Age =18 years
NYHA functional class III-IV
LVEF < 35 %
Optimized heart failure therapy according to the ESC guidelines
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Current therapy with omacor or other fish oil products
Known hypersensitivity to the study drug
Ischemic cardiomyopathy
Uncorrected significant valvular heart disase
Heart failure due to congenital heart disease
Restrictive cardiomyopathy
Alcoholic heart disease
Acute myocarditis
continuous i.v. therapy for heart failure
mechanical assist device
Life expectancy <1 year due to non-cardiac causes
Inability to perform bicycle testing
Women of childbearing potential who do not practice a save contraception method
Current participation in another intervention study.
Previous participation in another study with an intervention within the last 3 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate whether n3-fatty acids iimprove endothelial dysfunction in chronic heart failure.;Secondary Objective: To investigate whether n3-fatty acids have beneficial effects in chronic heart failure in terms of counteracting left ventricular remodelling, reducing ventricular wall stress, and improving exercise capacity.;Primary end point(s): Treatment-induced improvement in flow-mediated vasodilation as assessed by brachialis ultrasound
- Secondary Outcome Measures
Name Time Method