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Completed

NCT Number: NCT02286596

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

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.

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Key information

Conditions

Homozygous Familial Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Nutrition and Functional Foods (INAF)

Québec, Quebec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

heparin-induced extracorporeal LDL precipitation

Device

Lipid apheresis for 3 hours

Other names: Futura

dextran sulfate adsorption

Device

Lipid apheresis for 3 hours

Other names: Kaneka

Primary outcomes

  1. 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

  1. 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)

  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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Acronym: APHERESE

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Nov 10, 2014
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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