Familial HypercholesterolemiasATHERO-FHNCT06960902
Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
A study testing Coronary CT scan with CAC score measurement in people with Familial Hypercholesterolemias and Atherosclerotic Cardiovascular Disease (ASCVD), run by Nantes University Hospital at 9 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Familial Hypercholesterolemias, Atherosclerotic Cardiovascular Disease (ASCVD)
- What is being tested?
- Coronary CT scan with CAC score measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 9 sitesFrance
- Study dates
- 25 Sep 2025to 25 Sep 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon
Yves COTTIN, +33 3 80 29 35 36, yves.cottin@chu-dijon.fr
Yves COTTIN
- Not yet recruiting
CHRU Lille
Lille
Cécile YELNIK, +33 3 20 44 59 62, cecile.yelnik@chu-lille.fr
Cecile YELNIK
- Recruiting
Hospices Civils de Lyon
Lyon
Sybil CHARRIERE, +33 4 27 85 66 66, sybil.charriere@chu-lyon.fr
Sybil CHARRIERE
- Not yet recruiting
Hôpital de la Conception, AP-HM
Marseille
Sophie BELIARD-LASSERRE, +33 4 91 38 36 50, Sophie.beliard@ap-hm.fr
Sophie BELIARD-LASSERRE
- Recruiting
CHU Nantes
Nantes
Bertrand CARIOU, Pr, +33 2 53 48 27 10, bertrand.cariou@chu-nantes.fr
Bertrand CARIOU CARIOU
- Recruiting
Hôpital de la Pitié-Salpêtrière, AP-HP
Paris
Antonio GALLO, +33 1 42 17 57 85, Antonio.gallo@aphp.fr
Antonio GALLO
- Recruiting
Hôpital Saint-Antoine, AP-HP
Paris
Franck BOCCARA, +33 1 49 28 24 49, franck.boccara@aphp.fr
Franck BOCCARA
- Recruiting
CHU Rennes
Rennes
François PAILLARD, +33 2 99 28 25 40, francois.paillard@chu-rennes.fr
François PAILLARD
- Recruiting
CHU Strasbourg
Strasbourg
Alain PRADIGNAC, +33 3 88 12 75 89, alain.pradignac@chru-strasbourg.fr
Alain PRADIGNAC
About this study
Official title: Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia
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.
- Being tested
- Coronary CT scan with CAC score measurement
- Keywords
- Familial hypercholesterolemia, atherosclerotic cardiovascular disease
- Medical subject headings
- Hyperlipoproteinemia Type II, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT scan with CAC score measurementOther
Coronary CT scan with CAC score measurement (on the same day or within 6 months after the inclusion visit).
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Visit 1: Inclusion Visit: Verification of eligibility criteria. Consent form signing, collection of clinical information, and completion of questionnaires. Fasting blood draw for biological analyses and biobanking. Collection of urine and stool samples (optional). POpmeter (optional), Fibroscan (optional), completion of the CONSTANCES and SF36 questionnaires.
Visit 2 (30 months): Collection of the CAC score result (dated less than 6 months prior). Collection of clinical information and completion of questionnaires. Fasting blood draw for biological analyses and biobanking. Collection of urine and stool samples (optional). pOpmeter (optional), Fibroscan (optional), completion of the CONSTANCES and SF36 questionnaires.
Major cardiovascular events will be collected from patients during telephone calls at 1 and 2 years, and during the 30-month visit. Receives: Other: Coronary CT scan with CAC score measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of subclinical coronary atherosclerosis
The criterion defining the presence of subclinical coronary atherosclerosis is the presence of at least one coronary stenosis greater than 50% in a main artery on coronary CT angiography
Measured: At the time of performing the coronary CT scan
Secondary outcomes (31)
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
The anthropometric data collected as part of the current study will be comparable to the data collected as part of the SAFIR study
Measured: 30 months
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
The clinic data collected as part of the current study will be comparable to the data collected as part of the SAFIR study
Measured: 30 months
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
The drug treatments collected as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
The genetic data collected as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
The biological data collected as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
Arterial Doppler ultrasound of the carotid arteries and lower limbs as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
Pulse wave velocity measured by the pOpmeter as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
Hepatic steatosis as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
Hepatic fibrosis as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
Nutritional data as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
Physical activity as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
Quality of life as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile
The anthropometric data collected as part of the current study will be comparable to the data collected as part of the SAFIR study
Measured: 30 months
Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile
The clinic data collected as part of the current study will be comparable to the data collected as part of the SAFIR study
Measured: 30 months
Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile
The drug treatments collected as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile
The genetic data collected as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile
The biological data collected as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile
Arterial Doppler ultrasound of the carotid arteries and lower limbs as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile
Pulse wave velocity measured by the pOpmeter as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile
Hepatic steatosis as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile
Hepatic fibrosis as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile
Nutritional data as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile
Physical activity as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile
Quality of life as part of the current study will be comparable to the data collected as part of the SAFIR study.
Measured: 30 months
Study of the association between the characteristics of coronary atheroma plaque on coronary CT and major cardiovascular events at 30 months.
Semi-quantitative visual quantification of coronary stenoses on CT coronary angiography according to the CAD-RADS v2.0 classification and visual characterization of high-risk plaque features (vulnerability).
Measured: 30 months
Study of the association between the characteristics of coronary atheroma plaque on coronary CT and major cardiovascular events at 30 months.
Quantification of total coronary atherosclerotic plaque, calcified and non-calcified, and by artery
Measured: 30 months
Study of the association between the presence of subclinical atherosclerosis (coronary stenosis > 50% on CT coronary angiography) and major cardiovascular events at 30 months
Assess the association between the presence of significant coronary stenosis (>50% on a major artery) on coronary CT and the following major cardiovascular events:
- Acute coronary syndrome or myocardial infarction
- Coronary revascularization: angioplasty or bypass
- Ischemic stroke
- Carotid endarterectomy
- Revascularization of a lower limb artery: angioplasty or bypass
- Amputation related to PAD
- Cardiovascular death
Measured: 30 months
Study of the association between the percentile of the coronary calcium score and major cardiovascular events and overall mortality at 30 months
Assess the occurrence of major cardiovascular events and mortality according to the percentile of the coronary calcium score.
Measured: 30 months
Study of the association between arterial stiffness and major cardiovascular events and overall mortality at 30 months.
Assess the occurrence of major cardiovascular events and mortality according to the measurement of arterial stiffness evaluated by pulse wave velocity measured with the pOpmeter
Measured: 30 months
Study of the association between the presence of hepatic steatosis and major cardiovascular events and overall mortality at 30 months
Evaluer la survenue des événements cardiovasculaires majeurs et la mortalité en fonction de la stéatose hépatique
Measured: 30 months
Study of the association between the presence of liver fibrosis and major cardiovascular events and all-cause mortality at 30 months
Assess the occurrence of major cardiovascular events and mortality according to the presence of liver fibrosis
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start25 Sep 2025
- Primary completion25 Mar 2027 (estimated)
- Study completion25 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HypercholesterolemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pathophysiology study
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- France 2030 program, European Union
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960902
- Sponsor's protocol ID
- RC24_0343
- Other IDs
- 2025-A00453-46
- Acronym
- ATHERO-FH
- Status last verified
- Mar 2026
- First submitted
- 29 Apr 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided