Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Dijon Bourgogne
NOT_YET_RECRUITING
Dijon
CHRU Lille
NOT_YET_RECRUITING
Lille
Hospices Civils de Lyon
NOT_YET_RECRUITING
Lyon
Hôpital de la Conception, AP-HM
NOT_YET_RECRUITING
Marseille
CHU Nantes
RECRUITING
Nantes
Hôpital de la Pitié-Salpêtrière, AP-HP
NOT_YET_RECRUITING
Paris
Hôpital Saint-Antoine, AP-HP
NOT_YET_RECRUITING
Paris
CHU Rennes
NOT_YET_RECRUITING
Rennes
CHU Strasbourg
NOT_YET_RECRUITING
Strasbourg
Contact Information
Primary
Bertrand CARIOU, Pr
bertrand.cariou@chu-nantes.fr
+33 2 53 48 27 10
Time Frame
Start Date: 2025-09-25
Estimated Completion Date: 2029-09-25
Participants
Target number of participants: 600
Treatments
Other: Single arm
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.
Sponsors
Leads: Nantes University Hospital
Collaborators: France 2030 program, European Union Next Generation

This content was sourced from clinicaltrials.gov