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Hidden heart risks in inherited high cholesterol: new study aims to find them early

NCT ID NCT06960902

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

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

40 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHRU Lille

    NOT_YET_RECRUITING

    Lille, France

  • CHU Dijon Bourgogne

    RECRUITING

    Dijon, France

  • CHU Nantes

    RECRUITING

    Nantes, France

  • CHU Rennes

    RECRUITING

    Rennes, France

  • CHU Strasbourg

    RECRUITING

    Strasbourg, France

  • Hospices Civils de Lyon

    RECRUITING

    Lyon, France

  • Hôpital Saint-Antoine, AP-HP

    RECRUITING

    Paris, France

  • Hôpital de la Conception, AP-HM

    NOT_YET_RECRUITING

    Marseille, France

  • Hôpital de la Pitié-Salpêtrière, AP-HP

    RECRUITING

    Paris, France

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