NCT06960902Recruiting
Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- 25 Sept 2025
- Primary completion date
- 25 Mar 2027
- Lead sponsor
- Nantes University Hospital
- NCT number
- NCT06960902
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 25 Sept 2025 to the primary completion date, 25 Mar 2027
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject who has received oral or intravenous corticosteroid therapy within the last 6 months
- Subject receiving immunosuppressive or anticancer therapy
Other illness
- 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
- Subject with active cancer or in remission for less than 3 years
Lab values
- Severe renal insufficiency: estimated glomerular filtration rate (eGFR) according to the CKD-EPI formula ≤ 30 ml/min
Other
- Subject with a technical contraindication for coronary CT scan: patient diameter \> 70 cm and/or weight \> 250 kg
- Subject with untreated or poorly controlled hypothyroidism
- Subject refusing to participate
- Subject under guardianship, curatorship, or judicial protection, or without social insurance coverage
- Pregnant woman
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Dijon Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| CHRU Lille Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hôpital de la Conception, AP-HM Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Hôpital de la Pitié Salpêtrière - AP-HP Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Saint Antoine AP-HP Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHU Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| CHU Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.