NCT07427472 "Detection and Follow-up of Coronary Lesions in HeFH (DESTINY-FH Study)"
| NCT ID | NCT07427472 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Heterozygous Familial Hypercholesterolemia (HeFH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-06-19 |
| Primary Completion | 2028-06-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2026-06-19 with a primary completion date of 2028-06-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07427472 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 60 Years, studying Heterozygous Familial Hypercholesterolemia (HeFH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07427472 currently recruiting?
Yes, NCT07427472 is actively recruiting participants. Contact the research team at antonio.gallo@aphp.fr for enrollment information.
Where is the NCT07427472 trial being conducted?
This trial is being conducted at Paris, France, Paris, France, Paris, France.
Who is sponsoring the NCT07427472 clinical trial?
NCT07427472 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 300 participants.