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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000778-31-AT
Enrollment
145
Registered
2005-04-01
Start date
2005-02-08
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic heart failure

Interventions

Trade Name: Omacor Product Name: Omacor Product Code: 1-21530 Pharmaceutical Form: Capsule, soft INN or Proposed INN: eicosapentaeonic acid Concentration unit: mg milligram(s) Concentration type: equa

Sponsors

Dept. of Cardiology, Medical University of Vienna
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: chronic heart failure of non-ischemic origin Age =18 years NYHA functional class III-IV LVEF =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026