Actively Recruiting
Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
Led by Nantes University Hospital · Updated on 2026-03-19
600
Participants Needed
9
Research Sites
208 weeks
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
F
France 2030 program
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign the study consent form
- Affiliated with a current social security scheme
- Definite diagnosis of Familial Hypercholesterolemia with a Dutch Lipid Clinic Network score above 8 or identified causal mutation in LDLR, apolipoprotein B100, PCSK9, or apolipoprotein E genes
- Male aged 40 years or older, or female aged 50 years or older
- Ability to understand French for questionnaire completion
- Not taking lipid-lowering medication or on a stable dose for at least one month prior to inclusion (three months for PCSK9 inhibitors)
- Not taking antihypertensive medication or on a stable dose for at least one month prior to inclusion
- Not taking antidiabetic medication or on a stable dose for at least three months prior to inclusion
You will not qualify if you...
- Technical contraindication for coronary CT scan: diameter over 70 cm and/or weight over 250 kg
- History of atherosclerotic cardiovascular events such as myocardial infarction, ischemic heart disease, coronary revascularization, ischemic stroke, carotid endarterectomy, or lower limb arterial revascularization
- Allergy to iodinated contrast agents
- Severe renal insufficiency with estimated glomerular filtration rate 30 ml/min or less
- Active cancer or cancer remission less than 3 years
- Received oral or intravenous corticosteroid therapy within the last 6 months
- Untreated or poorly controlled hypothyroidism
- Receiving immunosuppressive or anticancer therapy
- Refusal to participate
- Under guardianship, curatorship, judicial protection, or without social insurance coverage
- Pregnant woman
AI-Screening
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Trial Site Locations
Total: 9 locations
1
CHU Dijon Bourgogne
Dijon, France
Actively Recruiting
2
CHRU Lille
Lille, France
Not Yet Recruiting
3
Hospices Civils de Lyon
Lyon, France
Actively Recruiting
4
Hôpital de la Conception, AP-HM
Marseille, France
Not Yet Recruiting
5
CHU Nantes
Nantes, France
Actively Recruiting
6
Hôpital de la Pitié-Salpêtrière, AP-HP
Paris, France
Actively Recruiting
7
Hôpital Saint-Antoine, AP-HP
Paris, France
Actively Recruiting
8
CHU Rennes
Rennes, France
Actively Recruiting
9
CHU Strasbourg
Strasbourg, France
Actively Recruiting
Research Team
B
Bertrand CARIOU, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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