Kidney Failure, Chronic
Conditions
Keywords
Chronic renal failure, Hemodialysis, OMACOR (omega-3-acid ethyl ester 90), intervention study, cardiovascular events, mortality
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.
Interventions
Sponsors
Danish Heart Foundation
The Danish Kidney Association
North Denmark Region
Pronova BioPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Death | — |
| - 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 | — |
| Composite endpoint, including either of the following events: | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 | — |
| - Efficacy laboratory variables (lipids, adhesion molecules, other efficacy lab variables, data for S-LDL-c size) | — |
Countries
Denmark
Outcome results
None listed