Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure

Tracking Information
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	Complete list of historical versions of study NCT00149409 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	Phase 2; Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Chronic Heart Failure
Intervention ICMJE	Dietary Supplement: Omacor
Study Arms	Placebo Comparator: Placebo 4 gelatine capsules/d Intervention: Dietary Supplement: Omacor; Active Comparator: 1g/d Omacor Intervention: Dietary Supplement: Omacor; Active Comparator: 4g/d Omacor Intervention: Dietary Supplement: Omacor
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE	Not Provided
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	February 2008
Actual Primary Completion Date	February 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Medical University of Vienna
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Rudolf Berger, MD Medical University of Vienna
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