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

Sponsor
Laval University (Other)
Overall Status
Completed
CT.gov ID
NCT02286596
Collaborator
(none)
9
Enrollment
1
Location
20
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: heparin-induced extracorporeal LDL precipitation
  • Device: dextran sulfate adsorption

Study Design

Study Type:
Observational
Actual Enrollment :
9 participants
Observational Model:
Case-Crossover
Time Perspective:
Retrospective
Official Title:
Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
heparin-induced extracorporeal LDL precipitation

Lipid apheresis treatment for 3 hours

Device: heparin-induced extracorporeal LDL precipitation
Lipid apheresis for 3 hours
Other Names:
  • Futura

    		•
    dextran sulfate adsorption

    Lipid apheresis treatment for 3 hours

    Device: dextran sulfate adsorption
    Lipid apheresis for 3 hours
    Other Names:
  • Kaneka

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Change in plasma adhesion molecule levels between the two lipid apheresis treatment [At the end of the two lipid apheresis (Week 0 and 2)]

    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)]

    3. Change in LDL particle size between the two lipid apheresis treatment [At the end of the two lipid apheresis (Week 0 and 2)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute of Nutrition and Functional Foods (INAF) Quebec Canada G1V 0A6

    Sponsors and Collaborators

    • Laval University

    Investigators

    • Principal Investigator: Patrick Couture, MD, FRCP, PhD, Laval University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Patrick Couture, MD, PhD, FRCP, Laval University
    ClinicalTrials.gov Identifier:
    NCT02286596
    Other Study ID Numbers:
    • APHERESE
    First Posted:
    Nov 10, 2014
    Last Update Posted:
    Mar 8, 2016
    Last Verified:
    Mar 1, 2016
    Additional relevant MeSH terms:
    Hyperlipoproteinemia Type II
    Hypercholesterolemia
    Heparin
    Dextrans

    Study Results

    No Results Posted as of Mar 8, 2016