Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

Phase 4

Completed

• Conditions: Kidney Failure, Chronic

• Registration Number: NCT00257283
• Lead Sponsor: Pronova BioPharma

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2002-11
• Study Completion: 2005-06
• Study First Submitted: 2005-11-21
• Study First Submitted QC: 2005-11-21
• Study First Posted: 2005-11-22
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-10
• Last Update Posted: 2008-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

  1. Angina pectoris
  2. Previous Acute myocardial infarction
  3. Previous PTCA/CABG or demonstated atheroclerosis after coronary angio
  4. Previous Transitory Cerebral Ischemia
  5. Previous Apoplexia Cerebri
  6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite endpoint, including either of the following events:
- Acute Myocardial Infarction
- Angina Pectoris, leading to coronary investigation or intervention
- Transient Cerebral Ischemia (TCI)
- Apoplexia cerebri (stroke)
- Peripheral Vascular disease, new symptoms or worsening of old symptoms
- Death

Secondary Outcome Measures

Name	Time	Method
- Efficacy laboratory variables (lipids, adhesion molecules, other efficacy lab variables, data for S-LDL-c size)
- Efficacy, fatty acid profile for phospholipids fraction
- Efficacy: diet registration, fish score
- Thrombosis and/or stenosis of dialysis graft
- Effect on heart rate variability, substudy of 50 patients at baseline and after three months

Trial Locations

Locations (1)

Department of Nephrology, Aalborg Hospital, Aarhus University Hospital; 🇩🇰 Aalborg, Denmark