Not yet recruitingNAINTERVENTIONAL

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

This study, called DESTINY-FH, is looking into how a condition called Heterozygous Familial Hypercholesterolemia (HeFH) affects your heart arteries over 5 years. HeFH is a genetic condition that causes high cholesterol from birth, which can lead to early narrowing of the arteries. Researchers will use special scans, called CT angiograms, to take detailed pictures of the arteries around the heart. They want to see if these arteries get worse, stay the same, or get better over time. The study aims to help doctors better understand how to manage HeFH and reduce the risk of heart problems for people living with this condition.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

300

Start

01 Apr 2026

Estimated completion

01 Dec 2035

Heterozygous Familial Hypercholesterolemia (HeFH)

What is this study about?

This research study, called DESTINY-FH, is investigating a genetic condition called Heterozygous Familial Hypercholesterolemia, or HeFH for short. If you have HeFH, your body produces too much 'bad' cholesterol (LDL-C) from a very young age. Over many years, this high cholesterol can cause a build-up of fatty deposits, called plaque, in the arteries that supply blood to your heart. This build-up can narrow the arteries and increase your risk of heart problems like heart attacks.

Doctors want to understand how these artery problems develop and change over time in people with HeFH. Standard tests don't always pick up all the early signs. This study will use a special type of X-ray called a CT coronary angiogram. This scan gives very detailed pictures of your heart arteries, showing if there is any plaque build-up, even if it's not hardened (calcified). By comparing scans taken several years apart, researchers can see if the artery narrowing has progressed, stayed the same, or even improved.

The findings from this study are important because they could help doctors make better decisions about how to look after people with HeFH. By getting a clearer picture of how artery disease progresses, they might be able to offer more effective treatments or lifestyle advice to lower the risk of future heart problems. This could lead to a better understanding of how to protect people from the long-term effects of HeFH.

Key takeaways

Study focuses on a genetic high cholesterol condition (HeFH).
Uses special heart scans (CCTA) to track artery changes over 5 years.
Aims to improve understanding of how HeFH affects heart health.
Participation involves a medical check-up and a CT scan, lasting up to one week.
Compares past scans with a new one to see progression of artery disease.

Who may be eligible?

To be considered for this study, you need to have been diagnosed with Heterozygous Familial Hypercholesterolemia (HeFH).

You must be between 35 and 60 years old and have had a specific heart artery scan (called a CCTA) at the Pitié Salpêtrière hospital imaging center at least 5 years ago, between 2018 and 2022. At the time of that previous scan, you shouldn't have been experiencing chest pain during exercise. You also need to be part of a social protection scheme in France and be able to understand and sign the consent form.

You cannot join the study if you are pregnant, breastfeeding, or could become pregnant without using effective contraception. Other reasons not to participate include having kidney problems, uncontrolled diabetes when you had your previous scan, a history of heart disease or heart attack at the time of your previous scan, or if you have certain allergies (to the dye used in scans or specific medications). If you had an adverse reaction to your previous CCTA scan or are taking part in another active research study, you would also not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have Heterozygous Familial Hypercholesterolemia (HeFH)?
Are you between 35 and 60 years old?
Did you have a CT Angiogram at Pitié Salpêtrière between 2018-2022?
Were you free of chest pain during exercise at the time of your previous scan?
Are you able to provide informed consent?

Answer every question to see your result.

What does participation involve?

If you take part in this study, your involvement will last for a short period, typically between one day and one week. During this time, you will have a medical check-up. The main part of your participation will involve having an updated CT coronary angiogram (CCTA) scan. This is a special X-ray that looks at your heart arteries. Researchers will compare this new scan with the one you had several years ago to see any changes. The overall study will run for two years, but your direct involvement is much shorter. Researchers will also continue to follow your health using your routine medical records for up to 10 years, to understand the long-term picture.

Potential risks and benefits

Participating in this study might help us gain a better understanding of how cholesterol affects heart arteries in people with HeFH, potentially leading to improved care for patients in the future. As with any medical procedure, there are some potential risks with the CT scan, such as exposure to a small amount of radiation or a reaction to the dye used. The study will only use existing scan information and a new, single scan. You are free to withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (2)

APHP- Hospital Saint-Antoine
Verified postcode
Paris, France
APHP-Sorbonne, Pitié Salpêtrière Hospital
Verified postcode
Paris, France

Common questions

What is HeFH?

HeFH stands for Heterozygous Familial Hypercholesterolemia. It's a genetic condition where your body has high levels of 'bad' cholesterol from birth, which can increase the risk of heart problems.

What is a CT coronary angiogram (CCTA)?

It's a special type of X-ray scan that takes detailed pictures of your heart arteries to look for any narrowing or plaque build-up.

Will I receive any new treatment in this study?

No, this study is about observing how your condition progresses using scans, not about testing new treatments. It's called an 'observational' study in that sense.

How long will I be involved if I join?

Your direct involvement, including check-ups and a scan, will typically last for one day to one week.

Where is this study taking place?

This study is being carried out in Paris, France, at La Pitié-Salpêtrière hospital and Saint Antoine Hospital.

How to find out more

Antonio GALLO, MD, PhD

antonio.gallo@aphp.fr 33(0)1 42 17 57 74 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.