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Bradykinin-degradating Enzymes Activities in Angiotensin-Converting Enzyme Inhibitors-associated Angioedema

This study aims to understand why some individuals experience recurring episodes of swelling, known as angioedema, after taking certain blood pressure medications called ACE inhibitors. Even when patients stop these medicines, the swelling can return, sometimes months later. The body naturally produces a substance called bradykinin, which can cause blood vessels to leak, leading to swelling. ACE inhibitors can cause bradykinin to build up. Researchers believe that some people might have lower levels of certain natural body chemicals that usually break down bradykinin. This study will measure these chemicals to see if their levels can predict who is more likely to have their swelling return after stopping ACE inhibitor medication.

At a glance

Status
Recruiting
Sponsor
University Hospital, Grenoble
Enrolment target
243
Start
27 Oct 2021
Estimated completion
26 Oct 2025

What is this study about?

When you take certain blood pressure medicines called Angiotensin-Converting Enzyme (ACE) inhibitors, some people can develop swelling, especially around the face, lips, tongue, or throat. This type of swelling is known as angioedema. It happens because ACE inhibitors can cause a natural body chemical called bradykinin to build up. Bradykinin makes blood vessels leaky, leading to swelling. While stopping the ACE inhibitor usually helps, sometimes the swelling can come back, even after the medication has been stopped for a while. This can be worrying and uncomfortable.

This study wants to find out why this happens. Researchers think that people who get recurring swelling might have lower levels of certain natural chemicals in their body that are supposed to break down bradykinin. If these 'bradykinin-degrading enzymes' aren't working properly, or if there aren't enough of them, bradykinin could continue to build up, leading to more swelling.

By measuring the activity of these enzymes in people who have had ACE inhibitor-related angioedema, the study hopes to find a way to predict who is at higher risk of their swelling returning. This information could help doctors better manage patients and even develop new treatments in the future.

Key takeaways

  • The study aims to understand recurrent swelling from ACE inhibitors.
  • It checks levels of body chemicals that break down swelling-causing substances.
  • Participation involves blood tests and no new medications.
  • Helps predict who might have swelling return after stopping medication.
  • Could lead to better management and treatments for angioedema.

Who may be eligible?

To be part of this study, you need to be at least 18 years old, male or female. You must have experienced swelling (angioedema) that is linked to taking ACE inhibitor blood pressure medication. This swelling should have started less than 15 days ago, or be a single episode of swelling (not itchy skin rashes/hives) that lasted at least 15 hours, and an expert doctor needs to confirm it's this type of angioedema. You also need to be able to understand and sign a consent form and be part of the social security system.

There are certain reasons why you wouldn't be able to join. For example, if you've had swollen episodes before taking an ACE inhibitor, or if you have certain genetic conditions related to swelling. You also can't take part if you're already in another medical study or if you're pregnant, breastfeeding, in prison, or under legal protection, as these situations require special considerations. People who can't be easily reached in an emergency are also not able to join.

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.

  1. Are you 18 years old or older?
  2. Have you recently experienced swelling linked to an ACE inhibitor (blood pressure medicine)?
  3. Have you NOT had swelling episodes before starting ACE inhibitor medication?
  4. Do you NOT have a known genetic condition related to swelling, like C1 inhibitor deficiency?
  5. Are you NOT pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

This study does not involve taking any new medications. If you take part, researchers will take blood samples to measure the activity of specific enzymes that break down bradykinin. The study will look at your history of swelling and track if it recurs over a period of time after you've stopped your ACE inhibitor medication. The exact number of visits or the total length of your participation is not specified but will be clearly explained in the consent form. This is an observational study, meaning you won't be given any new treatments.

Potential risks and benefits

There are no direct medical benefits to you from taking part in this study, but your participation could help researchers learn more about angioedema and improve care for others in the future. The main risk involves the blood tests, which usually only cause minor discomfort or bruising. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

  • Chu Grenoble Alpes
    Verified postcode
    Grenoble, France· Recruiting
  • CHRU de Lille _Hôpital Claude-Huriez
    Verified postcode
    Lille, France· Recruiting
  • AP-HP _St Antoine
    Verified postcode
    Paris, France· Recruiting
  • CHU de Rouen
    Verified postcode
    Rouen, France· Recruiting

Common questions

What is angioedema?

Angioedema is a type of swelling that happens under the skin, often around the face, lips, tongue, or throat. It can be caused by certain medications or other health conditions.

What are ACE inhibitors?

ACE inhibitors are common medications prescribed to help lower blood pressure and treat other heart conditions.

Why is this study important?

This study is important because it aims to understand why angioedema can return even after stopping ACE inhibitor medication, which could help doctors better predict and manage who is at risk.

Will I have to take new medication in this study?

No, this study is about understanding your body's natural processes, not about testing new medicines. You won't be given any experimental drugs.

What is bradykinin?

Bradykinin is a natural chemical in your body that can make blood vessels leak, leading to swelling. ACE inhibitors can cause too much bradykinin to build up.

How to find out more

Federica DEFENDI, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Bradykinin-degradating Enzymes Activities in Angiotensin-Con…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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