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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Department of Nephrology, Aalborg Hospital, Aarhus University Hospital
Aalborg, Denmark
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
- 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
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