Clinical trial NCT00257283: Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis
Official title: A Double Blind Comparison of Omacor and Placebo as Secondary Prevention Against Cardiovascular Events in Patients Undergoing Chronic Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Keywords: Chronic renal failure
Hemodialysis
OMACOR (omega-3-acid ethyl ester 90)
intervention study
cardiovascular events
mortality
Lead sponsor: Pronova BioPharma
Sponsor class: INDUSTRY
Collaborators: name: Danish Heart Foundation
name: The Danish Kidney Association
name: North Denmark Region
First posted: 2005-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite endpoint, including either of the following events:
measure: - Acute Myocardial Infarction
measure: - Angina Pectoris, leading to coronary investigation or intervention
measure: - Transient Cerebral Ischemia (TCI)
measure: - Apoplexia cerebri (stroke)
measure: - Peripheral Vascular disease, new symptoms or worsening of old symptoms
measure: - Death
Secondary outcomes:
measure: - Efficacy laboratory variables (lipids, adhesion molecules, other efficacy lab variables, data for S-LDL-c size)
measure: - Efficacy, fatty acid profile for phospholipids fraction
measure: - Efficacy: diet registration, fish score
measure: - Thrombosis and/or stenosis of dialysis graft
measure: - Effect on heart rate variability, substudy of 50 patients at baseline and after three months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Nephrology, Aalborg Hospital, Aarhus University Hospital
Study officials:
affiliation: Department of Nephrology, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark
name: My Svensson, MD
role: PRINCIPAL_INVESTIGATOR
References: