CompletedNCT02286596APHERESEUpdated Mar 8, 2016

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

An observational study in Homozygous Familial Hypercholesterolemia, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-03-08.

Sponsored by Laval University · Observational

Study type: Observational
Model: Case-crossover
Time perspective: Retrospective
Enrollment: 9
Ages: 18 Years to 60 Years
Sex: All

Study 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.

Conditions studied

Homozygous Familial Hypercholesterolemia

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In context

Hyperlipoproteinemia Type II

245 studies on the registry are indexed under Hyperlipoproteinemia Type II; 52 are open to participants now.

This study's enrollment of 9 is below the median of 743 across 66 observational studies indexed under Hyperlipoproteinemia Type II.

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Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients with homozygous familial hypercholesterolemia already treated with LDL apheresis using both systems being compared (HELP vs Dextran)

Inclusion criteria

Aged between 18-65 years
Subjects with homozygous familial hypercholesterolemia:
Carrier of a mutation in the LDL receptor gene

Exclusion criteria

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

Observational model: Case-crossover
Time perspective: Retrospective
Enrollment: 9 participants (actual)
Patient registry: No

Groups and cohorts

heparin-induced extracorporeal LDL precipitation
Lipid apheresis treatment for 3 hours
Device: heparin-induced extracorporeal LDL precipitation
dextran sulfate adsorption
Lipid apheresis treatment for 3 hours
Device: dextran sulfate adsorption

Interventions

Deviceheparin-induced extracorporeal LDL precipitation
Lipid apheresis for 3 hours
Also known as: Futura
Devicedextran sulfate adsorption
Lipid apheresis for 3 hours
Also known as: Kaneka

What researchers measure

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)

Study locations

1 site

Institute of Nutrition and Functional Foods (INAF)
Quebec, G1V 0A6, Canada

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02286596
Lead sponsor: Laval University
Responsible party: Patrick Couture (MD, PhD, FRCP, Laval University) — Principal investigator
First posted: Nov 10, 2014
Start date: Apr 2013
Primary completion: Jun 2013
Completion: Dec 2014
Last update: Mar 8, 2016

Study contacts

Patrick Couture, MD, FRCP, PhD

principal investigator · Laval University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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