RecruitingOBSERVATIONAL

CLOUD-R HAE REGISTRY

This study is a registry, which means it's collecting information about people who have a rare swelling condition called angioedema. We are particularly interested in cases where the swelling happens without an itchy rash (hives). Angioedema can cause parts of the body, like the skin, gut, or throat, to swell up. While usually harmless, swelling in the throat can be serious. Because these specific types of angioedema are rare, doctors don't have a lot of information about many patients. This registry aims to bring together details from lots of people with these conditions to help us understand them better, track how they affect people over time, and ultimately improve the way they are diagnosed and managed.

At a glance

Status

Recruiting

Sponsor

University Hospital, Grenoble

Enrolment target

1,000

Start

01 Sep 2018

Estimated completion

01 Sep 2028

ANGIOEDEMA

What is this study about?

This study is building a confidential database, called a registry, focusing on a specific type of swelling condition known as angioedema. Angioedema causes sudden, temporary swelling in different parts of your body, like your skin, stomach, or even your throat. These swellings typically last a few days and then go away on their own. While often uncomfortable, swelling in the throat can be dangerous, so understanding these conditions is really important.

There are different kinds of angioedema. This registry is specifically looking at types that *don't* come with an itchy rash called hives. Some of these can run in families (hereditary), while others develop later in life. Because these forms of angioedema are quite rare, doctors haven't had the chance to study many patients at once. This makes it harder to fully understand them and develop the best ways to help people.

The main goal of this registry is to collect detailed information from a large number of people across France who experience these specific types of angioedema. By bringing all this information together in one place, researchers hope to gain a much clearer picture of who gets these conditions, how they affect people over time, and what triggers these swelling attacks. This better understanding could lead to improved diagnosis, treatments, and overall care for people living with angioedema.

Key takeaways

Collecting vital information on rare angioedema without hives.
Aims to improve understanding and future care for patients.
Participation involves sharing health information and using a diary app.
No new treatments are given as part of this study.
Your privacy and data are protected.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to have a type of swelling condition called angioedema, but it must be one that *doesn't* come with an itchy rash (hives).

This includes people with hereditary angioedema, whether they have a problem with a specific protein called C1 or not.

You can take part if you are an adult and can give your permission to join. If you are under 18, your parents or legal guardians must give their permission for you 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.

Do you experience swelling (angioedema)?
Does your swelling usually happen *without* an itchy rash (hives)?
Are you able to give your consent to take part (or are you a parent/guardian of a minor)?
Are you currently under the care of a specialist who can link you to the registry?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your local hospital or clinic will collect information about your angioedema. This will include details about your condition, how it affects you, and information about any swelling attacks you experience. You will also be asked to create a personal account to use a special app called "cloud R HAE carnet de suivi". This app is like an electronic diary where you can record your symptoms and any crises.

Each time you visit your clinic or after you've had a swelling attack and reported it in your electronic diary, the healthcare team looking after you will review and confirm the information. The clinics involved also promise to keep the main study team updated on how many people are joining the registry and how things are progressing. The total duration of your participation is ongoing, as this is a registry collecting information over a long period.

Potential risks and benefits

Taking part in this study means sharing information about your health. The main benefit is that you will be contributing to a better understanding of rare angioedema conditions, which could help future patients. There are no direct medical benefits to you personally from taking part. The main risk is the potential for your personal health information to be accidentally shared, though strict rules are in place to protect your privacy and keep your information safe. You are free to stop taking part in the registry at any time, without giving a reason, and this will not affect your medical care.

Locations (1)

University Hospital Grenoble
Verified postcode
Grenoble, France· Recruiting

Common questions

What is angioedema?

Angioedema is a condition that causes sudden swelling under the skin or in other parts of the body like the gut or throat, which typically lasts for a few days.

What kind of angioedema is this study looking for?

This study is specifically looking at types of angioedema that do not involve an itchy rash, sometimes called hives. This includes hereditary forms.

Why is this registry important?

Because these forms of angioedema are rare, doctors don't have much information about them. This registry will gather lots of data to help improve understanding and care for patients.

Will I receive new treatment if I join?

No, this is a registry, not a treatment trial. It's about collecting information to better understand the condition, not testing new medications.

What happens to my personal information?

Your personal health information will be collected securely by your clinic and shared with the main study team. Strict rules are in place to keep your data private and safe.

How to find out more

laurence bouilelt, MD, PhD

lbouillet@chu-grenoble.fr +33476765565 Official trial record

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