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

Completed

• Conditions: Homozygous Familial Hypercholesterolemia
• Interventions: Device: heparin-induced extracorporeal LDL precipitation; Device: dextran sulfate adsorption

• Registration Number: NCT02286596
• Lead Sponsor: Laval University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-06
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-10
• Study Completion: 2014-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
heparin-induced extracorporeal LDL precipitation	heparin-induced extracorporeal LDL precipitation	Lipid apheresis treatment for 3 hours
dextran sulfate adsorption	dextran sulfate adsorption	Lipid apheresis treatment for 3 hours

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Institute of Nutrition and Functional Foods (INAF); 🇨🇦 Quebec, Canada