Homozygous Familial HypercholesterolemiaAPHERESENCT02286596
Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia
An observational study of Homozygous Familial Hypercholesterolemia, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Homozygous Familial Hypercholesterolemia
- What is being tested?
- heparin-induced extracorporeal LDL precipitation and dextran sulfate adsorption
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with homozygous familial hypercholesterolemia already treated with LDL apheresis using both systems being compared (HELP vs Dextran)
Who may be able to join
- Aged between 18-65 years
- Subjects with homozygous familial hypercholesterolemia:
- Carrier of a mutation in the LDL receptor gene
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutrition and Functional Foods (INAF)
Québec, Quebec, G1V 0A6
About this study
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.
- Conditions
- Homozygous Familial Hypercholesterolemia
- Being tested
- heparin-induced extracorporeal LDL precipitation, dextran sulfate adsorption
- Medical subject headings
- Homozygous Familial Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparin-induced extracorporeal LDL precipitationDevice
Also called Futura
Lipid apheresis for 3 hours
dextran sulfate adsorptionDevice
Also called Kaneka
Lipid apheresis for 3 hours
| Study group | Role | What they receive |
|---|---|---|
| heparin-induced extracorporeal LDL precipitation | Lipid apheresis treatment for 3 hours Receives: Device: heparin-induced extracorporeal LDL precipitation | |
| dextran sulfate adsorption | Lipid apheresis treatment for 3 hours Receives: Device: dextran sulfate adsorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma lipid levels between the two lipid apheresis treatment
Measured: 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
Measured: At the end of the two lipid apheresis (Week 0 and 2)
Change in plasma inflammatory marker levels between the two lipid apheresis treatment
Measured: At the end of the two lipid apheresis (Week 0 and 2)
Change in LDL particle size between the two lipid apheresis treatment
Measured: At the end of the two lipid apheresis (Week 0 and 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Homozygous Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Couture, Laval University
- Investigators
- Patrick Couture, MD, FRCP, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286596
- Sponsor's protocol ID
- APHERESE
- Acronym
- APHERESE
- Status last verified
- Mar 2016
- First submitted
- 3 Nov 2014
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT02286596
- Acronym / sponsor ID
- APHERESE / APHERESE
- Conditions
- Homozygous Familial Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heparin-induced extracorporeal LDL precipitation | – | Device: heparin-induced extracorporeal LDL precipitationLipid apheresis treatment for 3 hours |
| dextran sulfate adsorption | – | Device: dextran sulfate adsorptionLipid apheresis treatment for 3 hours |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with homozygous familial hypercholesterolemia already treated with LDL apheresis using both systems being compared (HELP vs Dextran)
Key inclusion criteria (3 listed)
- Aged between 18-65 years
- Subjects with homozygous familial hypercholesterolemia:
- Carrier of a mutation in the LDL receptor gene
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heparin-induced extracorporeal LDL precipitationAlso: FuturaLipid apheresis for 3 hours | Device | heparin-induced extracorporeal LDL precipitation |
| dextran sulfate adsorptionAlso: KanekaLipid apheresis for 3 hours | Device | dextran sulfate adsorption |
Primary outcome
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)
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Couture, MD, FRCP, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Homozygous Familial Hypercholesterolemia, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.