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

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Medical University of Vienna

Status and phase

Completed
Phase 3
Phase 2

Conditions

Chronic Heart Failure

Treatments

Dietary Supplement: Omacor

Study type

Interventional

Funder types

Other

Identifiers

NCT00149409
n3-PUFA-HF

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
4 gelatine capsules/d
Treatment:
Dietary Supplement: Omacor
1g/d Omacor
Active Comparator group
Treatment:
Dietary Supplement: Omacor
4g/d Omacor
Active Comparator group
Treatment:
Dietary Supplement: Omacor

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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