Coronary Plaque Progression in HeFH: DESTINY-FH
Official title: Detection and Longitudinal Follow-up of Non-calcified and Calcified Coronary Lesions in Heterozygous Familial Hypercholesterolemia (DESTINY-FH)
Run by Assistance Publique - Hôpitaux de Paris · NCT07427472 · Data updated 2026-11-12
This study tests how heart arteries change over 5 years in people with heterozygous familial hypercholesterolemia using coronary CT angiography.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years to 60 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 3 sites (Paris and 2 other locations) |
| Status | Recruiting |
| Started | June 19, 2026 |
| Main results expected | June 19, 2028 |
| Study ends | June 19, 2036 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT07427472 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 30–60 with genetically confirmed HeFH, previously had CAC and CCTA at the same center, and are asymptomatic for exertional chest pain.
✕Probably not a fit
Patients without HeFH or those outside the 30–60 age range, or those unable to complete imaging procedures, may not benefit from the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, non-randomized interventional study follows adults with confirmed HeFH to track progression of coronary artery disease over five years using CCTA. It compares baseline imaging from 2018–2022 with a study visit to categorize changes in CAD-RADS v2.0 as regression, stability, or progression. The trial plans to enroll 300 participants (100 protected, 200 non-protected) across Parisian hospitals, with an initial one-week participation and extended follow-up through routine care data for up to 10 years. The investigation will assess both calcified and non-calcified plaque burden to better understand risk in HeFH beyond CAC scoring.
Why it matters
Potential benefit: If successful, it could improve understanding of plaque progression in HeFH and help tailor surveillance and management strategies.
How similar studies have gone: Prior research indicates non-calcified plaques can be common in HeFH, suggesting imaging-based monitoring can provide clinically meaningful information.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
APHP-Sorbonne, Pitié Salpêtrière Hospital
Paris, Île-de-France Region, France Recruiting -
Plateau d'investigation clinique (PIC) IHU-ICAN
Paris, France Not yet recruiting -
APHP- Hospital Saint-Antoine
Paris, Île-de-France Region, France Not yet recruiting
Study contacts
- Study coordinator: Antonio GALLO, MD, PhD
- Email: antonio.gallo@aphp.fr
- Phone: 33(0)1 42 17 57 74
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CTX310 for refractory high triglycerides or LDL cholesterol
This trial will test whether a single IV dose of CTX310 is safe and tolerated in adults whose high triglycerides or LDL cholesterol have not responded to available treatments.
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ORIGIN-FH: Newborn screening to detect familial high cholesterol
This project will test a genetic cheek swab of parents plus blood screening of newborns to find familial high cholesterol in babies born to parents with familial hypercholesterolemia.
-
SYH2053 Injection for adults with heterozygous familial hypercholesterolemia
A phase 3 trial tests whether SYH2053 injection, added to standard diet and statin therapy, can lower LDL cholesterol in adults with HeFH compared with placebo.
-
Enlicitide decanoate (MK-0616), an oral PCSK9 inhibitor, for children and adolescents with heterozygous familial hypercholesterolemia
This trial tests whether a daily oral medicine called enlicitide decanoate can safely lower LDL cholesterol in children and teens with heterozygous familial hypercholesterolemia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.