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| Name | Class |
|---|---|
| Danish Heart Foundation | OTHER |
| The Danish Kidney Association | OTHER |
| North Denmark Region | OTHER_GOV |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3-acid ethyl esters 90 | Drug |
| 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 |
| 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 | ||
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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
Written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| My Svensson, MD | Department of Nephrology, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology, Aalborg Hospital, Aarhus University Hospital | Aalborg | 9100 | Denmark |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| - 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |