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

Laval University

Status

Completed

Conditions

Homozygous Familial Hypercholesterolemia

Treatments

Device: dextran sulfate adsorption

Device: heparin-induced extracorporeal LDL precipitation

Study type

Observational

Funder types

Other

Identifiers

NCT02286596

APHERESE

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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