RecruitingNAINTERVENTIONAL

Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)

This study, called ATHERO-FH, is for people with Familial Hypercholesterolemia (FH), a genetic condition leading to very high cholesterol. Researchers want to understand how heart disease, specifically blocked arteries, starts in these individuals. They'll use special CT scans of the heart to look for tiny calcium deposits in the arteries. These deposits can be an early sign of heart disease. The study aims to look at how common these early signs are across different risk groups based on the scan results. By understanding this better, doctors might be able to offer more tailored advice and treatment to people with FH to keep their hearts healthy.

At a glance

Status

Recruiting

Phase

Sponsor

Nantes University Hospital

Enrolment target

600

Start

25 Sep 2025

Estimated completion

25 Sep 2029

Familial Hypercholesterolemias Atherosclerotic Cardiovascular Disease (ASCVD)

What is this study about?

This study, called ATHERO-FH, is about a condition called Familial Hypercholesterolemia (FH). This is a genetic condition that means you have very high levels of cholesterol in your blood from birth. Over time, high cholesterol can cause a build-up of fatty deposits in your arteries, narrowing them and making it harder for blood to flow. This can lead to serious heart problems.

The main goal of this research is to understand how these fatty deposits, which doctors call 'atherosclerosis', develop in people with FH. It's like trying to find early warning signs. The researchers will use a special type of scan called a Coronary CT scan. This scan can show if there are tiny specks of calcium in your heart arteries. These calcium specks are an early indicator that fatty deposits might be forming, even before you feel any symptoms.

By looking at these calcium scores in different people with FH, the study hopes to learn more about who might be at higher or lower risk of developing heart disease. This information could eventually help doctors give more personalised advice and better treatments to people with FH, aiming to protect their hearts in the best possible way. This study does not involve new medicines; it's purely about gaining a better understanding through advanced imaging.

Key takeaways

Study examines early heart disease in people with Familial Hypercholesterolemia (FH).
Uses a special heart CT scan to look for calcium deposits (early signs).
Aims to improve understanding and future care for FH patients.
Does not involve new medications, only scans and follow-up.
Participation includes two clinic visits and two phone calls over 2.5 years.

Who may be eligible?

To join this study, you must have a clear diagnosis of Familial Hypercholesterolemia (FH), either confirmed by a special scoring system (Dutch Lipid Clinic Network score over 8) or by a genetic test showing a fault in specific genes related to cholesterol. You also need to be willing to sign a consent form, be part of a social security scheme, and be able to understand French well enough for questionnaires. Men need to be 40 years or older, and women 50 years or older.

There are also some rules about your current medications. If you take medication for cholesterol, high blood pressure, or diabetes, it needs to have been at a steady dose for a certain amount of time before the study starts. You cannot have had a previous heart attack, stroke, or any procedure to unblock arteries. You also can't be pregnant, have certain severe kidney problems, have had cancer recently, or be allergic to the dye used in CT scans. There are also some size and weight limits for the CT scan equipment.

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 a clear diagnosis of Familial Hypercholesterolemia (FH)?
Are you a man aged 40 or older, or a woman aged 50 or older?
Do you understand French for questionnaires?
Have you not had a heart attack, stroke, or heart artery procedure before?
Are you not pregnant or severely allergic to CT scan dye?
Are your existing medications (if any) for cholesterol, blood pressure, or diabetes stable?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have an initial visit to the study centre. Within six months of this first visit, you will need to have a Coronary CT scan of your heart. This scan will check for any calcium in your heart's arteries. After this, the study team will contact you by phone after one year and again after two years to check in. Finally, you will have another visit to the study centre after about 30 months (two and a half years) from your start date. This study does not involve taking any new medications; it focuses on understanding your condition through scans and follow-up checks.

Potential risks and benefits

Taking part in research like this helps us learn more about health conditions, which can benefit others in the future. The main procedure you'll undergo is a CT scan, which involves exposure to a small amount of radiation, similar to several X-rays. There's also a very small risk of an allergic reaction to the dye used in the scan, though staff will be on hand. You can stop participating in the study at any time, for any reason, without it affecting your usual medical care. The information gathered may not directly benefit you, but it will help doctors in the future better understand and manage FH for many people.

Locations (9)

CHU Dijon Bourgogne
Verified postcode
Dijon, France· Recruiting
CHRU Lille
Verified postcode
Lille, France· Not yet recruiting
Hospices Civils de Lyon
Verified postcode
Lyon, France· Recruiting
Hôpital de la Conception, AP-HM
Verified postcode
Marseille, France· Not yet recruiting
CHU Nantes
Verified postcode
Nantes, France· Recruiting
Hôpital de la Pitié-Salpêtrière, AP-HP
Verified postcode
Paris, France· Recruiting
Hôpital Saint-Antoine, AP-HP
Verified postcode
Paris, France· Recruiting
CHU Rennes
Verified postcode
Rennes, France· Recruiting
CHU Strasbourg
Verified postcode
Strasbourg, France· Recruiting

Common questions

What is Familial Hypercholesterolemia (FH)?

FH is a genetic condition that causes very high cholesterol levels from birth, which can increase the risk of heart disease.

What is a Coronary CT scan?

It's a special X-ray scan of your heart that can show if there are tiny calcium deposits in your heart's arteries, which can be an early sign of heart disease.

Will I have to take new medicine in this study?

No, this study does not involve any new medicines. It focuses on using scans and understanding your condition.

How long will I be in the study?

You will be in the study for about two and a half years, including two visits and two phone calls.

What are the main risks?

The main risks are a small radiation exposure from the CT scan and a very small chance of an allergic reaction to the dye used during the scan.

How to find out more

Bertrand CARIOU, Pr

bertrand.cariou@chu-nantes.fr +33 2 53 48 27 10 Official trial record

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