Hypercholesterolemia, FamilialHYPERCHOFNCT06555120
Screening for Familial Hypercholesterolemia in Children
A study testing blood sample in people with Hypercholesterolemia, Familial, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Familial hypercholesterolemia is the most common treatable genetic disorder for which a simple, effective treatment is available, with few side effects. It leads to a significant increase in LDL levels, generally in excess of 1.9g/l, including in children. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Familial
- What is being tested?
- blood sample
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 2 and 18 years
- Minimum 8-hour fasting
- Parents and children with signed informed consent
Who cannot join
- Known familial hypercholesterolemia
- Diabetes less than one month old
- Profound hypothyroidism
- Acute nephrotic syndrome
- cancer under treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Amiens
Amiens, 80480
Gwendoline Buissart, MD, 03220880 ext. 33, buissart.gwendoline@chu-amiens.fr
About this study
Familial hypercholesterolemia is the most common treatable genetic disorder for which a simple, effective treatment is available, with few side effects.
It leads to a significant increase in LDL levels, generally in excess of 1.9g/l, including in children. It is much higher than the values usually found in secondary or polygenic hypercholesterolemia. This condition multiplies the cardiovascular risk in adulthood by a factor of 13, and is responsible for 6,500 early cardiovascular events per year. In the absence of treatment, the state of the arteries of patients with familial hypercholesterolemia, at the age of 40, would be equivalent to that of 80-year-olds.
Read more
Currently, the prevalence is estimated at 1 in 300 people in France. However, this prevalence is largely underestimated, as targeted screening is rarely carried out, and it is estimated that only 10% of sufferers are diagnosed in France, and only 5% of affected children are known and treated.
Today, according to the French health authority, the indications for screening children are: a history of an early vascular event in one of the two parents, or familial hypercholesterolemia in a first-degree relative.
However, the World Health Organization and numerous studies recommend extending screening to the general population. Screening all children and teenagers could make it possible to introduce healthy dietary habits at an early stage, to better adapt the choice of contraception in young women, to treat before the first symptoms appear and thus reduce mortality in adulthood by up to 48%, and to screen relatives who have not yet had a cardiovascular event.
In Slovenia, 90% of children have had a lipid panel since 1994, significantly reducing mortality. In the United Kingdom, the lipid check-up, offered as part of a compulsory visit at the age of two, is being rolled out: 90% of families naturally take it up on the recommendation of their doctors.
The treatment of hypercholesterolemia is simple, and relies first and foremost on hygienic dietary rules and treatments such as statins and Liptruzet (a combination of atorvastatin and ezetimibe), treatments that are easily accessible, effective, with few side effects and low cost.
- Conditions
- Hypercholesterolemia, Familial
- Being tested
- blood sample
- Keywords
- hypercholesterolemia, familial
- Medical subject headings
- Hyperlipoproteinemia Type II, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
A 5-ml blood sample in a dry tube (or 500-µl cone) is taken and sent to the biochemistry laboratory for lipid analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of hypercholesterolemia in children in the general population
Measured: at 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start2 Jan 2025
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercholesterolemia, FamilialStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555120
- Sponsor's protocol ID
- PI2024_843_0045
- Acronym
- HYPERCHOF
- Status last verified
- Feb 2026
- First submitted
- 13 Aug 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Familial Hypercholesterolemia in Children
- ClinicalTrials.gov ID
- NCT06555120
- Acronym / sponsor ID
- HYPERCHOF / PI2024_843_0045
- Conditions
- Hypercholesterolemia, Familial
- Keywords
- hypercholesterolemia, familial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 15 Aug 2024 (actual)
- 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.
Familial hypercholesterolemia is the most common treatable genetic disorder for which a simple, effective treatment is available, with few side effects.
It leads to a significant increase in LDL levels, generally in excess of 1.9g/l, including in children. It is much higher than the values usually found in secondary or polygenic hypercholesterolemia. This condition multiplies the cardiovascular risk in adulthood by a factor of 13, and is responsible for 6,500 early cardiovascular events per year. In the absence of treatment, the state of the arteries of patients with familial hypercholesterolemia, at the age of 40, would be equivalent to that of 80-year-olds.
Currently, the prevalence is estimated at 1 in 300 people in France. However, this prevalence is largely underestimated, as targeted screening is rarely carried out, and it is estimated that only 10% of sufferers are diagnosed in France, and only 5% of affected children are known and treated.
Today, according to the French health authority, the indications for screening children are: a history of an early vascular event in one of the two parents, or familial hypercholesterolemia in a first-degree relative.
However, the World Health Organization and numerous studies recommend extending screening to the general population. Screening all children and teenagers could make it possible to introduce healthy dietary habits at an early stage, to better adapt the choice of contraception in young women, to treat before the first symptoms appear and thus reduce mortality in adulthood by up to 48%, and to screen relatives who have not yet had a cardiovascular event.
In Slovenia, 90% of children have had a lipid panel since 1994, significantly reducing mortality. In the United Kingdom, the lipid check-up, offered as part of a compulsory visit at the age of two, is being rolled out: 90% of families naturally take it up on the recommendation of their doctors.
The treatment of hypercholesterolemia is simple, and relies first and foremost on hygienic dietary rules and treatments such as statins and Liptruzet (a combination of atorvastatin and ezetimibe), treatments that are easily accessible, effective, with few side effects and low cost.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age between 2 and 18 years
- Minimum 8-hour fasting
- Parents and children with signed informed consent
Key exclusion criteria (5 listed)
- Known familial hypercholesterolemia
- Diabetes less than one month old
- Profound hypothyroidism
- Acute nephrotic syndrome
- cancer under treatment
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 |
|---|---|---|
| blood sampleA 5-ml blood sample in a dry tube (or 500-µl cone) is taken and sent to the biochemistry laboratory for lipid analysis. | Biological | – |
Primary outcome
prevalence of hypercholesterolemia in children in the general population
Time frame: at 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Hypercholesterolemia, Familial, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 5 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: looking for participants now, as of the sponsor's last update on 12 Feb 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact gwendoline Buissart, MD (0322838466 ext. 33, buissart.gwendoline@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of hypercholesterolemia in children in the general population (time frame: at 16 months). 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 12 Feb 2026.