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

March 7, 2016 updated by: Patrick Couture, Laval University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
At the end of the two lipid apheresis (Week 0 and 2)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
At the end of the two lipid apheresis (Week 0 and 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHERESE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Homozygous Familial Hypercholesterolemia

Clinical Trials on heparin-induced extracorporeal LDL precipitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe