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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02286596
Acronym
APHERESE
Enrollment
9
Registered
2014-11-10
Start date
2013-04-30
Completion date
2014-12-31
Last updated
2016-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Homozygous Familial Hypercholesterolemia

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

DEVICEheparin-induced extracorporeal LDL precipitation

Lipid apheresis for 3 hours

DEVICEdextran sulfate adsorption

Lipid apheresis for 3 hours

Sponsors

Laval University
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

MeasureTime frame
Change in plasma lipid levels between the two lipid apheresis treatmentAt the end of the two lipid apheresis (Week 0 and 2)

Secondary

MeasureTime frame
Change in plasma adhesion molecule levels between the two lipid apheresis treatmentAt the end of the two lipid apheresis (Week 0 and 2)
Change in plasma inflammatory marker levels between the two lipid apheresis treatmentAt the end of the two lipid apheresis (Week 0 and 2)
Change in LDL particle size between the two lipid apheresis treatmentAt the end of the two lipid apheresis (Week 0 and 2)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026