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

Laval University9 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Homozygous Familial Hypercholesterolemia

Interventions

heparin-induced extracorporeal LDL precipitationDEVICE

Lipid apheresis for 3 hours

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Time frame: At the end of the two lipid apheresis (Week 0 and 2)

Change in plasma inflammatory marker levels between the two lipid apheresis treatment

Time frame: At the end of the two lipid apheresis (Week 0 and 2)

Change in LDL particle size between the two lipid apheresis treatment

Time frame: At the end of the two lipid apheresis (Week 0 and 2)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes