Hidden heart risks in inherited high cholesterol: new study aims to find them early
NCT ID NCT06960902
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with familial hypercholesterolemia (inherited high cholesterol) who have no heart symptoms yet. Researchers will use a special CT scan to check for hidden blockages in the heart arteries. The goal is to learn which factors are linked to these blockages, so doctors can better predict and prevent heart problems in the future. About 600 adults aged 40 and older (men) or 50 and older (women) will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Person willing to sign the study consent form * Person affiliated with a current social security scheme * Person with a definite diagnosis of Familial Hypercholesterolemia, defined by a Dutch Lipid Clinic Network (DLCN) clinical-biological score \> 8 and/or an identified causal mutation in the LDL receptor (LDLR) gene, apolipoprotein B100 gene, PCSK9 gene, or apolipoprotein E gene * Male aged 40 years or older, or female aged 50 years or older * Ability to understand French for questionnaire completion * Person not taking any lipid-lowering medication or on a stable dose of lipid-lowering therapy for at least one month prior to inclusion (three months for PCSK9 inhibitors) at Visit 1 * Person not taking any antihypertensive medication or on a stable dose of antihypertensive therapy for at least one month at Visit 1 * Person not taking any antidiabetic medication or on a stable dose of antidiabetic therapy for at least 3 months at Visit 1 Exclusion Criteria: * Subject with a technical contraindication for coronary CT scan: patient diameter \> 70 cm and/or weight \> 250 kg * Patient with a history of atherosclerotic cardiovascular event (myocardial infarction, ischemic heart disease, coronary revascularization, ischemic stroke, carotid endarterectomy, lower limb arterial revascularization) * Patient allergic to iodinated contrast agents * Severe renal insufficiency: estimated glomerular filtration rate (eGFR) according to the CKD-EPI formula ≤ 30 ml/min * Subject with active cancer or in remission for less than 3 years * Subject who has received oral or intravenous corticosteroid therapy within the last 6 months * Subject with untreated or poorly controlled hypothyroidism * Subject receiving immunosuppressive or anticancer therapy * Subject refusing to participate * Subject under guardianship, curatorship, or judicial protection, or without social insurance coverage * Pregnant woman
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHRU Lille
NOT_YET_RECRUITINGLille, France
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CHU Dijon Bourgogne
RECRUITINGDijon, France
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CHU Nantes
RECRUITINGNantes, France
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CHU Rennes
RECRUITINGRennes, France
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CHU Strasbourg
RECRUITINGStrasbourg, France
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Hospices Civils de Lyon
RECRUITINGLyon, France
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Hôpital Saint-Antoine, AP-HP
RECRUITINGParis, France
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Hôpital de la Conception, AP-HM
NOT_YET_RECRUITINGMarseille, France
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Hôpital de la Pitié-Salpêtrière, AP-HP
RECRUITINGParis, France
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Other studies related to the condition(s) this trial covers.
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