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ClinicalTrials.gov ID

NCT06960902

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

600Estimated

Last Update Posted

Mar 19, 2026Actual

Start Date

Sep 25, 2025Actual

Primary Completion Date

Mar 25, 2027Estimated

Completion Date

Sep 25, 2029Estimated

Official Title

Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia

Brief Summary

The goal of this study (interventional clinical research not involving a health product) is to assess the prevalence of subclinical coronary atherosclerosis diagnosed by coronary CT angiography in heart failure patients in primary prevention, across different levels of cardiovascular risk defined by coronary artery calcium (CAC) score percentiles (based on data from the MESA study): low risk (≤25th percentile for age, sex, and ethnicity), intermediate risk (25th < CAC ≤ 75th percentile), and high risk (>75th percentile). The Patients will attend an on-site visit at inclusion (and must undergo a coronary CT angiography within 6 months following this visit), will be contacted by phone at 1 year and 2 years, and will return for an on-site visit at 30 months.

• Familial Hypercholesterolemias
• Atherosclerotic Cardiovascular Disease (ASCVD)

• Coronary CT scan with CAC score measurement

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Nantes University HospitalOTHER

Collaborators

France 2030 programUNKNOWN

European UnionOTHER

cecile.yelnik@chu-lille.fr+33 3 20 44 59 62

bertrand.cariou@chu-nantes.fr+33 2 53 48 27 10

francois.paillard@chu-rennes.fr+33 2 99 28 25 40