Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure
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ClinicalTrials.gov Identifier: NCT00149409 |
Recruitment Status :
Completed
First Posted : September 8, 2005
Last Update Posted : July 13, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Heart Failure | Dietary Supplement: Omacor | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
4 gelatine capsules/d
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Dietary Supplement: Omacor |
Active Comparator: 1g/d Omacor |
Dietary Supplement: Omacor |
Active Comparator: 4g/d Omacor |
Dietary Supplement: Omacor |

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149409
Austria | |
Medical University of Vienna | |
Vienna, Austria, A-1090 |
Principal Investigator: | Rudolf Berger, MD | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00149409 |
Other Study ID Numbers: |
n3-PUFA-HF |
First Posted: | September 8, 2005 Key Record Dates |
Last Update Posted: | July 13, 2010 |
Last Verified: | September 2005 |
Heart Failure Heart Diseases Cardiovascular Diseases |