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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Sponsor:
Medical University of Vienna
Information provided by:
Medical University of Vienna
Tracking Information | ||||
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First Submitted Date ICMJE | September 6, 2005 | |||
First Posted Date ICMJE | September 8, 2005 | |||
Last Update Posted Date | July 13, 2010 | |||
Study Start Date ICMJE | September 2005 | |||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure | |||
Official Title ICMJE | 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 | |||
Brief Summary | To investigate whether n3-fatty acids have beneficial effects in chronic heart failure as regards circulatory function. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Heart Failure | |||
Intervention ICMJE | Dietary Supplement: Omacor | |||
Study Arms ICMJE |
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | February 2008 | |||
Actual Primary Completion Date | February 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00149409 | |||
Other Study ID Numbers ICMJE | n3-PUFA-HF | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Not Provided | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Medical University of Vienna | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Medical University of Vienna | |||
Verification Date | September 2005 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |