NCT00149409

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

July 13, 2010

Status Verified

September 1, 2005

Enrollment Period

2.4 years

First QC Date

September 6, 2005

Last Update Submit

July 12, 2010

Conditions

Chronic Heart Failure

Study Arms (3)

Placebo

PLACEBO COMPARATOR

4 gelatine capsules/d

Dietary Supplement: Omacor

1g/d Omacor

ACTIVE COMPARATOR
Dietary Supplement: Omacor

4g/d Omacor

ACTIVE COMPARATOR
Dietary Supplement: Omacor

Interventions

OmacorDIETARY_SUPPLEMENT
1g/d Omacor4g/d OmacorPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, A-1090, Austria

Location

Related Publications (1)

  • Moertl D, Hammer A, Steiner S, Hutuleac R, Vonbank K, Berger R. Dose-dependent effects of omega-3-polyunsaturated fatty acids on systolic left ventricular function, endothelial function, and markers of inflammation in chronic heart failure of nonischemic origin: a double-blind, placebo-controlled, 3-arm study. Am Heart J. 2011 May;161(5):915.e1-9. doi: 10.1016/j.ahj.2011.02.011.

    PMID: 21570522DERIVED

MeSH Terms

Interventions

Omacor

Study Officials

  • Rudolf Berger, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

September 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

July 13, 2010

Record last verified: 2005-09

Locations

AU(1)