NCT02286596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

2 months

First QC Date

November 3, 2014

Last Update Submit

March 7, 2016

Conditions

Homozygous Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (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 Outcomes (3)

  • Change in plasma adhesion molecule levels between the two lipid apheresis treatment

    At the end of the two lipid apheresis (Week 0 and 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)

  • Change in LDL particle size between the two lipid apheresis treatment

    At the end of the two lipid apheresis (Week 0 and 2)

Study Arms (2)

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

heparin-induced extracorporeal LDL precipitationDEVICE

Lipid apheresis for 3 hours

Also known as: Futura
heparin-induced extracorporeal LDL precipitation
dextran sulfate adsorptionDEVICE

Lipid apheresis for 3 hours

Also known as: Kaneka
dextran sulfate adsorption

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutrition and Functional Foods (INAF)

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Homozygous Familial Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipoproteinemia Type IILipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Patrick Couture, MD, FRCP, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FRCP

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 10, 2014

Study Start

April 1, 2013

Primary Completion

June 1, 2013

Study Completion

December 1, 2014

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

CA(1)