Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia

Study Overview
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Brief Summary
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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.

Official Title
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Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia

Conditions
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Homozygous Familial Hypercholesterolemia

Intervention / Treatment
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* Device: heparin-induced extracorporeal LDL precipitation
* Device: dextran sulfate adsorption


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| heparin-induced extracorporeal LDL precipitation<br>Lipid apheresis treatment for 3 hours | Device: heparin-induced extracorporeal LDL precipitation<br>* Lipid apheresis for 3 hours<br>* Other names: Futura;|
| dextran sulfate adsorption<br>Lipid apheresis treatment for 3 hours | Device: dextran sulfate adsorption<br>* Lipid apheresis for 3 hours<br>* Other names: Kaneka;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) |