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

Recruiting now · Not applicable

Conditions studied: Heterozygous Familial Hypercholesterolemia (HeFH)

In brief

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.

Key facts

Study ID

NCT07427472

Run by

Assistance Publique - Hôpitaux de Paris

People needed

300

Starts

2026-06-19

Expected to finish

2036-06-19

Last updated by the study team

2026-06-24

Who can join

Age: 30 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with heterozygous familial hypercholesterolemia
• Aged 30 to 60 years.
• 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).
• Patient asymptomatic for exertional chest pain at the time of CCTA
• Clinical examination performed
• Beneficiary of a social protection scheme or entitled person (excluding AME)
• Patient informed and consent form signed

You may not qualify if…

• Patient under guardianship, or unable to give consent
• Pregnancy, breast-feeding
• Technical contraindication: weight > 250 kg
• Simultaneous participation in other interventional research involving the human body, or period of exclusion following previous research involving the human body still in progress.
• Adults subject to a legal protection order
• Contraindication to esmolol and/or atenolol
• 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

Where it is running

• APHP-Sorbonne, Pitié Salpêtrière Hospital — Paris, Île-de-France Region, France (enrolling)
• Plateau d'investigation clinique (PIC) IHU-ICAN — Paris, France
• APHP- Hospital Saint-Antoine — Paris, Île-de-France Region, France

Full record on ClinicalTrials.gov

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