Homozygous Familial Hypercholesterolemia
Conditions
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.
Interventions
Lipid apheresis for 3 hours
Lipid apheresis for 3 hours
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in plasma lipid levels between the two lipid apheresis treatment | At the end of the two lipid apheresis (Week 0 and 2) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
Countries
Canada