Clinical trial NCT06960902: Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
Official title: Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Familial Hypercholesterolemias
Atherosclerotic Cardiovascular Disease (ASCVD)
Keywords: Familial hypercholesterolemia
atherosclerotic cardiovascular disease
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: France 2030 program
name: European Union Next Generation
First posted: 2025-05-07
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pathophysiology study
Primary purpose: OTHER

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

Primary outcomes:
measure: Presence of subclinical coronary atherosclerosis
timeFrame: At the time of performing the coronary CT scan
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Hôpital de la Conception, AP-HM
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hôpital de la Pitié-Salpêtrière, AP-HP
city: Paris
country: France
facility: Hôpital Saint-Antoine, AP-HP
city: Rennes
country: France
facility: CHU Rennes
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
References: