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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00149409
Other study ID # n3-PUFA-HF
Secondary ID
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


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, 

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