NCT06960902 Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
| NCT ID | NCT06960902 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Familial Hypercholesterolemias |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-09-25 |
| Primary Completion | 2027-03-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2025-09-25 with a primary completion date of 2027-03-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06960902 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Familial Hypercholesterolemias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06960902 currently recruiting?
Yes, NCT06960902 is actively recruiting participants. Contact the research team at bertrand.cariou@chu-nantes.fr for enrollment information.
Where is the NCT06960902 trial being conducted?
This trial is being conducted at Dijon, France, Lille, France, Lyon, France, Marseille, France and 5 additional locations.
Who is sponsoring the NCT06960902 clinical trial?
NCT06960902 is sponsored by Nantes University Hospital. The trial plans to enroll 600 participants.