Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Homozygous Familial Hypercholesterolemia
- Sponsor
- Laval University
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Change in plasma lipid levels between the two lipid apheresis treatment
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Homozygous familial hypercholesterolemia (HoFH) is characterized by a six- to eight-fold raise in plasma LDL-cholesterol (LDL-C) concentrations and atherosclerotic coronary artery disease usually occur before the age of 20 if untreated. Lipid apheresis (LA) has been proved to be a reliable method to decrease LDL-C concentrations and therefore decrease cardiovascular disease risk in HoFH. The objective of this crossover study was to compare efficacy of LA performed with heparin-induced extracorporeal LDL precipitation to dextran sulfate adsorption on the reduction of lipids, inflammatory markers, adhesion molecules and LDL particles size in a cohort of HoFH subjects.
Investigators
Patrick Couture
MD, PhD, FRCP
Laval University
Eligibility Criteria
Inclusion Criteria
- •Aged between 18-65 years
- •Subjects with homozygous familial hypercholesterolemia:
- •Carrier of a mutation in the LDL receptor gene
Exclusion Criteria
- •Subjects with a previous history of cardiovascular disease
- •Subjects with Type 2 diabetes
- •Were pregnant or nursing;
- •Subjects with a history of cancer
- •Subjects with acute liver disease, hepatic dysfunction, or persistent elevations of serum transaminases
- •Subjects with a secondary hyperlipidemia due to any cause
- •History of alcohol or drug abuse within the past 2 years
- •hormonal treatment
- •Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
Outcomes
Primary Outcomes
Change in plasma lipid levels between the two lipid apheresis treatment
Time Frame: At the end of the two lipid apheresis (Week 0 and 2)
Secondary Outcomes
- Change in plasma adhesion molecule levels between the two lipid apheresis treatment(At the end of the two lipid apheresis (Week 0 and 2))
- Change in plasma inflammatory marker levels between the two lipid apheresis treatment(At the end of the two lipid apheresis (Week 0 and 2))
- Change in LDL particle size between the two lipid apheresis treatment(At the end of the two lipid apheresis (Week 0 and 2))