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New treatment option for Heterozygous Familial Hypercholesterolemia (HeFH)
Official title "Detection and Follow-up of Coronary Lesions in HeFH (DESTINY-FH Study)"
ClinicalTrials.gov ID: NCT07427472
What this study is testing
- What it's testing
- 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.
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 60
You may be able to join 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...
- Patient asymptomatic for exertional chest pain at the time of CCTA
- Clinical examination performed
You likely can't join if
- Patient under guardianship, or unable to give consent
- Pregnancy, breast-feeding
- Technical contraindication: weight \> 250 kg
- Simultaneous participation in other treatment research involving the human body, or period of exclusion following previous research involving the...
- Adults subject to a legal protection order
- Contraindication to esmolol and/or atenolol
See the full eligibility criteria
- 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
- Patient under guardianship, or unable to give consent
- Pregnancy, breast-feeding
- Technical contraindication: weight \> 250 kg
- Simultaneous participation in other treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
- Paris, Île-de-France Region, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France; Paris, Île-de-France Region, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.