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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

Omacor

About this trial

This is an interventional treatment trial for Chronic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

1g/d Omacor

4g/d Omacor

Arm Description

4 gelatine capsules/d

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00149409

First Posted

September 6, 2005

Last Updated

July 12, 2010

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00149409

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

4 gelatine capsules/d

Arm Title

1g/d Omacor

Arm Type

Active Comparator

Arm Title

4g/d Omacor

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Omacor

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rudolf Berger, MD

Organizational Affiliation

Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Vienna

City

Vienna

ZIP/Postal Code

A-1090

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

21570522

Citation

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.

Results Reference

derived

Chronic Heart Failure

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial