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Clinical Trials in France / NCT07427472
Recruiting Not applicable

"Detection and Follow-up of Coronary Lesions in HeFH (DESTINY-FH Study)"

NCT07427472 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2026-06-19
Last updated
2026-06-24

Condition(s) studied

Heterozygous Familial Hypercholesterolemia (HeFH)

Investigational drug(s) / intervention(s)

Coronary computed tomography angiography

Coronary computed tomography angiography: Coronary computed tomography angiography with injection of iodinated contrast material

Study summary

This multicenter, non-randomized interventional study aims to assess coronary artery disease progression over 5 years in patients with genetically confirmed heterozygous familial hypercholesterolemia (HeFH), using coronary computed tomography angiography (CCTA).

The primary endpoint is the visual evaluation of coronary stenosis using CAD-RADS v2.0, identifying changes between baseline (2018-2022) and study inclusion. The study will enroll 300 patients (100 protected, 200 non-protected) from La Pitié-Salpêtrière hospital and Saint Antoine Hospital (Paris). Participation lasts up to one week. Total study duration is 2 years, with extended follow-up through routine care data over 10 years.

Eligibility

Sex
ALL
Min age
30 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients with heterozygous familial hypercholesterolemia 2. Aged 30 to 60 years. 3. Patients who underwent a CAC score and a coronary CT angiogram at least 5 years ago, exclusively at the same imaging center (ICT de la Pitié Salpetrière). 4. Patient asymptomatic for exertional chest pain at the time of CCTA 5. Clinical examination performed 6. Beneficiary of a social protection scheme or entitled person (excluding AME) 7. Patient informed and consent form signed Exclusion Criteria: 1. Patient under guardianship, or unable to give consent 2. Pregnancy, breast-feeding 3. Technical contraindication: weight \> 250 kg 4. Simultaneous participation in other interventional research involving the human body, or period of exclusion following previous research involving the human body still in progress. 5. Adults subject to a legal protection order 6. Contraindication to esmolol and/or atenolol 7. Only for patients who need to undergo a CT angiogram and a thoraco-abdominal-pelvic CT scan: * Renal insufficiency (LC\<60) * Unbalanced diabetes when acquiring a previous coronary angioscanner * Personal history of cardiovascular disease and myocardial infarction at the time of CCTA * Contraindication to iodinated contrast media * Patient having already had an adverse event (AE) during the acquisition of a prior coronary angioscanner

Primary outcome measure(s)

  • Progression of coronary artery disease over 5 years in patients with heterozygous familial hypercholesterolemia — 1 day
    The evolution of coronary artery disease will be assessed over 5 years in patients with heterozygous familial hypercholesterolemia using coronary CT angiography (CTA). The number of patients with regression, stability, or progression of coronary stenosis will be determined using semi-quantitative visual assessment of coronary stenoses according to the CAD-RADS v2.0 classification, including visual characterization of high-risk plaque features.Time Frame: 5 years Unit of Measure: Number and percentage of participants with regression, stability, or progression of coronary stenosis

Trial sites (3)

FacilityCityRegionStatus
Plateau d'investigation clinique (PIC) IHU-ICAN Paris France Not Yet Recruiting
APHP- Hospital Saint-Antoine Paris Île-de-France Region Not Yet Recruiting
APHP-Sorbonne, Pitié Salpêtrière Hospital Paris Île-de-France Region Recruiting

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Other trials for the same condition

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07427472 on ClinicalTrials.gov ↗ ← All trials in France