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Completed

NCT Number: NCT00257283

Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

The aim of this investigator initated study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Nephrology, Aalborg Hospital, Aarhus University Hospital

Aalborg, 9100, Denmark

About this study

Patients with renal failure have a high incidence of cardiovascular disease and increased premature mortality. Omega-3 polyunsaturated fatty acids from fish are known to have cardioprotective effects in subects with normal renal function. The aim of present study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.

Design: A prospective, randomised, placebo controlled study. 2 year treatment period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females above 18 years of age
  • Patients having been treated with chronic hemodialysis for at least 6 months
  • Patients with documented cardiovascular disease, at least one of the following
  • Angina pectoris
  • Previous Acute myocardial infarction
  • Previous PTCA/CABG or demonstated atheroclerosis after coronary angio
  • Previous Transitory Cerebral Ischemia
  • Previous Apoplexia Cerebri
  • Symptoms of peripheral vascular disease
  • Written informed consent

Exclusion criteria

  • Active malignant disease, except basal cell carcinoma or spinocellular carcinoma
  • Patients undergoing peritoneal dialysis
  • Any condition associated with a risk of poor compliance, as judged by investigator
  • Pregnant or breastfeeding
  • Participation in other clinical studies involving treatment with drugs.

Treatment and study plan

Omega-3-acid ethyl esters 90

Drug

Primary outcomes

  1. Composite endpoint, including either of the following events:

  2. - Acute Myocardial Infarction

  3. - Angina Pectoris, leading to coronary investigation or intervention

  4. - Transient Cerebral Ischemia (TCI)

  5. - Apoplexia cerebri (stroke)

  6. - Peripheral Vascular disease, new symptoms or worsening of old symptoms

  7. - Death

Secondary outcomes

  1. - Efficacy laboratory variables (lipids, adhesion molecules, other efficacy lab variables, data for S-LDL-c size)

  2. - Efficacy, fatty acid profile for phospholipids fraction

  3. - Efficacy: diet registration, fish score

  4. - Thrombosis and/or stenosis of dialysis graft

  5. - Effect on heart rate variability, substudy of 50 patients at baseline and after three months

Sponsors and collaborators

Lead sponsor

Pronova BioPharma

Industry

Collaborators

  • Danish Heart Foundation
  • North Denmark Region
  • The Danish Kidney Association

Registry information

Official study title

A Double Blind Comparison of Omacor and Placebo as Secondary Prevention Against Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

Important dates

Study start
2002
Study completion
2005
First posted
Nov 22, 2005
Registry last updated
Mar 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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