An interventional study of blood sample in Hypercholesterolemia, Familial, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other
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.
249 studies on the registry are indexed under Hyperlipoproteinemia Type II; 56 are open to participants now.
This study's planned enrollment of 300 is above the median of 134 across 178 interventional studies indexed under Hyperlipoproteinemia Type II.
Browse Hyperlipoproteinemia Type II studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 5-ml blood sample in a dry tube (or 500-µl cone) is taken and sent to the biochemistry laboratory for lipid analysis.
prevalence of hypercholesterolemia in children in the general population
Time frame: at 16 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Aug 2026, 19 months after the start.
Of 35 non-industry interventional studies with no phase under Hyperlipoproteinemia Type II, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's planned 19 months is below that.
Counting every sponsor, half of 37 studies reached it within 29 months; a quarter within 12 and three quarters within 41.
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Hyperlipoproteinemia Type II →
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