Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149409
• Other study ID #: n3-PUFA-HF
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 6, 2005
• Last updated: July 12, 2010
• Start date: September 2005
• Est. completion date: February 2008

Study information

• Verified date: September 2005
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

To investigate whether n3-fatty acids have beneficial effects in chronic heart failure as regards circulatory function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic heart failure of non-ischemic origin

• Age =18 years

• NYHA functional class III-IV

• LVEF < 35 %

• Optimized heart failure therapy

• plasma NT-BNP >2000pg/ml

Exclusion Criteria:

• Current treatment with Omacor or other fish oil products

• Known hypersensitivity to the study drug

• Ischemic cardiomyopathy

• Uncorrected significant valvular heart disease

• 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 not practicing a save contraception method

• Current participation in another intervention study

• Participation in another study with an intervention within the last 3 months.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Dietary Supplement:
• Omacor

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria,