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NCT07427472Recruiting

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

Detection and Longitudinal Follow-up of Non-calcified and Calcified Coronary Lesions in Heterozygous Familial Hypercholesterolemia (DESTINY-FH)

Source: ClinicalTrials.gov · Last updated 24 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
300 (estimated)
First submitted
14 Aug 2025
Start date
19 Jun 2026
Primary completion date
19 Jun 2028
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT07427472

What you commit to

  • Study type: Interventional
  • Planned participants: 300
  • From 19 Jun 2026 to the primary completion date, 19 Jun 2028
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Simultaneous participation in other interventional research involving the human body, or period of exclusion following previous research involving the human body still in progress.
  • 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

Other

  • Patient under guardianship, or unable to give consent
  • Pregnancy, breast-feeding
  • Technical contraindication: weight \> 250 kg
  • Adults subject to a legal protection order
  • Contraindication to esmolol and/or atenolol

Who the study is looking for

  • 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

Age in the registry: 30 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
APHP-Sorbonne, Pitié Salpêtrière Hospital
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Plateau d'investigation clinique (PIC) IHU-ICAN
Coordinator of this site? Confirm its status
ParisFranceNot yet recruiting
APHP Hospital Saint-Antoine
Coordinator of this site? Confirm its status
ParisFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.