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Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure
This study has been completed.
Sponsor:
Medical University of Vienna
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00149409
First received: September 6, 2005
Last updated: July 12, 2010
Last verified: September 2005
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Purpose
To investigate whether n3-fatty acids have beneficial effects in chronic heart failure as regards circulatory function.
| Condition | Intervention | Phase |
|---|---|---|
| Chronic Heart Failure | Dietary Supplement: Omacor | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
MedlinePlus related topics:
Heart Failure
Drug Information available for:
Omega-3-acid ethyl esters
U.S. FDA Resources
Further study details as provided by Medical University of Vienna:
| Study Start Date: | September 2005 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
4 gelatine capsules/d
|
Dietary Supplement: Omacor |
| Active Comparator: 1g/d Omacor | Dietary Supplement: Omacor |
| Active Comparator: 4g/d Omacor | Dietary Supplement: Omacor |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149409
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149409
Locations
| Austria | |
| Medical University of Vienna | |
| Vienna, Austria, A-1090 | |
Sponsors and Collaborators
Medical University of Vienna
Investigators
| Principal Investigator: | Rudolf Berger, MD | Medical University of Vienna |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00149409 History of Changes |
| Other Study ID Numbers: |
n3-PUFA-HF |
| Study First Received: | September 6, 2005 |
| Last Updated: | July 12, 2010 |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 28, 2017