Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Drug: Omega-3-acid ethyl esters 90


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Omega-3-acid ethyl esters 90|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic renal failure, Hemodialysis, OMACOR (omega-3-acid ethyl ester 90), intervention study, cardiovascular events, mortality