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

Homozygous Familial Hypercholesterolemia Clinical Trial

— APHERESE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286596
• Other study ID #: APHERESE
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: March 7, 2016
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Homozygous Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

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

Locations

Country	Name	City	State
Canada	Institute of Nutrition and Functional Foods (INAF)	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma lipid levels between the two lipid apheresis treatment		At the end of the two lipid apheresis (Week 0 and 2)	No
Secondary	Change in plasma adhesion molecule levels between the two lipid apheresis treatment		At the end of the two lipid apheresis (Week 0 and 2)	No
Secondary	Change in plasma inflammatory marker levels between the two lipid apheresis treatment		At the end of the two lipid apheresis (Week 0 and 2)	No
Secondary	Change in LDL particle size between the two lipid apheresis treatment		At the end of the two lipid apheresis (Week 0 and 2)	No