RecruitingNAINTERVENTIONAL

Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways

This study aims to create a local bank of blood samples and health information for people in South-East France who were born with heart conditions (congenital heart defects). While these heart conditions affect many babies, the specific reasons behind most of them are still a mystery. By collecting this information, scientists hope to learn more about the genetic causes of these conditions. This local collection will help researchers in Marseille study heart defects more effectively, leading to better understanding and potentially new treatments for affected children and adults. It's an important step in helping those with lifelong heart conditions.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique Hopitaux De Marseille

Enrolment target

300

Start

17 Jan 2017

Estimated completion

01 Mar 2028

Congenital Heart Defects

What is this study about?

Imagine a big library, but instead of books, it stores valuable information about people's health. This study is creating a special 'library', called SEA-HD, in South-East France specifically for people who were born with heart problems. These are known as 'congenital heart defects'. While we know these conditions affect many babies, often we don't fully understand why they happen.

Scientists believe that our genes play a big part in why some people are born with heart defects. By gathering blood samples and clear health information from many individuals with these conditions, researchers can study their genetic makeup. This will help them find common patterns and unlock some of the mysteries behind these heart problems. Having this information close by in Marseille makes it much easier for local experts to conduct their research.

Ultimately, this research aims to improve our understanding of congenital heart defects. This better understanding could lead to new ways to prevent, diagnose, or treat these conditions, helping children and adults live healthier lives. It's a long-term effort, but an important one for the future of heart health.

Key takeaways

This study is collecting blood samples and health information from people with heart problems they were born with.
The goal is to understand the genetic causes of these heart conditions better.
Participation involves providing a blood sample during a routine hospital visit.
It's for patients receiving care at AP-HM Timone Hospital in Marseille.
Your contribution could help improve future treatments for congenital heart defects.
Your decision to participate is voluntary and won't affect your medical care.

Who may be eligible?

This study is looking for people who have been diagnosed with a heart condition that they were born with. This diagnosis needs to be confirmed by a special heart scan called an echocardiogram, and your condition should fit into a specific classification system used by doctors.

You also need to be having a blood test anyway, as part of your normal medical care, regardless of this study. The study also requires that you receive your medical care at the AP-HM Timone Hospital in Marseille, specifically in the children's heart unit there.

There are certain situations where you would not be able to join. For example, if you are pregnant, or if you (or your child's parent/guardian, if they are under 18) are unable to understand and agree to take part due to physical or mental reasons. People who are in emergency situations, those who are not covered by the social security system, or who are deprived of their freedom (like being in prison) also cannot join. If you are a resident in a health or social care institution, you would also not be able to take part.

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.

Have you been diagnosed with a heart condition you were born with, confirmed by an echocardiogram?
Are you already scheduled to have a blood test as part of your medical care?
Do you receive your medical care at the AP-HM Timone Hospital in Marseille?
Are you (or your child's parent/guardian, if applicable) able to understand and agree to take part?
Are you NOT pregnant (if applicable)?
Are you NOT in an emergency situation or deprived of your freedom?

Answer every question to see your result.

What does participation involve?

Taking part in this study is quite simple, as it mainly involves providing a small blood sample. This sample would be collected at the same time as any other routine blood tests you might already be having for your medical care at the AP-HM Timone Hospital. You won't need extra visits or special assessments just for this study.

The blood sample will be stored in a special bank along with your health information, to be used by researchers to study congenital heart defects. Your participation doesn't involve taking any new medications or undergoing specific follow-up appointments related solely to the study. The total duration of your participation is just the time it takes to provide that one blood sample and have your doctor share your relevant health information with the research team.

Potential risks and benefits

The main benefit of taking part is contributing to important medical research that could one day help other people born with heart conditions. By sharing your information, you are helping scientists better understand why these conditions happen and how they might be treated in the future. The risks are very low, as it only involves giving a blood sample that you would likely be giving anyway for your regular medical care. Like any blood test, there's a very small chance of bruising or discomfort at the needle site. You have the full right to change your mind and withdraw from the study at any time, without it affecting your medical care.

Locations (1)

Assistance Publique Hopitaux de Marseille
Verified postcode
Marseille, France· Recruiting

Common questions

What is a 'congenital heart defect'?

It's a problem with the heart's structure that a baby is born with. It means the heart didn't form completely or correctly during pregnancy.

Why do you need my blood sample?

Your blood contains your DNA, which holds your genetic information. Scientists want to study the DNA of people with heart defects to find out if there are common genetic reasons why these conditions happen.

Will this study help me directly?

It's unlikely this study will directly benefit you personally. However, the information gathered could lead to better understanding and treatments for future generations of people with congenital heart defects.

Will my personal details be kept private?

Yes, all your personal information will be kept strictly confidential and your samples will be coded so your identity is protected during research.

Do I have to take part?

No, taking part is completely your choice. If you decide not to, or if you change your mind later, it will not affect your medical care in any way.

How to find out more

CAROLINE OVAERT

caroline.ovaert@ap-hm.fr Official trial record

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