Investigating enzyme activities related to angioedema from ACE inhibitors
Official title: Prognostic Value of the Bradykinin-degradating Enzymes Activities on the Relapse Risk of Angiotensin-Converting Enzyme Inhibitors-associated Angioedema
Run by University Hospital, Grenoble · NCT04763577 · Data updated 2026-11-12
This study is trying to see how certain enzymes behave in people who have swelling caused by ACE inhibitors to help predict if they might have a relapse after stopping the medication.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 243 (estimated) |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 4 sites (Grenoble and 3 other locations) |
| Status | Recruiting |
| Started | October 27, 2021 |
| Main results expected | October 26, 2025 |
| Study ends | October 26, 2025 |
| Registry record updated | February 25, 2025 |
| Trial ID | NCT04763577 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have developed angioedema secondary to ACE inhibitor treatment within the last 15 days.
✕Probably not a fit
Patients with a history of angioedema prior to ACE inhibitor treatment or those with specific genetic deficiencies will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on angioedema caused by angiotensin-converting enzyme inhibitors (ACEi-AE), a condition linked to the accumulation of bradykinin, which increases vascular permeability. The study aims to assess the activity of bradykinin-degrading enzymes in patients experiencing this type of angioedema. By understanding the relationship between enzyme activity and the risk of relapse after discontinuation of ACE inhibitors, the researchers hope to identify predictive markers for recurrence. The study includes patients who have recently developed angioedema related to ACE inhibitors and excludes those with certain genetic conditions or prior episodes of angioedema.
Why it matters
Potential benefit: If successful, this study could help predict the risk of angioedema recurrence in patients, potentially guiding treatment decisions.
How similar studies have gone: While the specific approach of this study may be novel, similar studies have explored the relationship between bradykinin and angioedema, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women at least 18 years old * Presenting AE secondary to treatment with Angiotensin Conversion Enzyme Inhibitors for less than 15 days, or an isolated AE (without superficial hives), which lasts at least 15 hours, and whose diagnosis is validated by the expert committee, * Having signed informed and written consent * And being affiliated with social security Exclusion Criteria: * Patient who had one or more AEs prior to IEC * Hereditary or acquired deficiency of C1 inhibitor * Subject with known mutation of the F12 or PLG gene Subject in times of exclusion from another research involving the human person type 1 or 2 Persons referred to in sections L1121-5 to L1121-8 of the public health code (pregnant woman, breastfeeding mother, person deprived of liberty, person subject to legal protection) subject that cannot be contacted in an emergency situation
Where it's running
-
Chu Grenoble Alpes
Grenoble, France Recruiting -
CHRU de Lille _Hôpital Claude-Huriez
Lille, France Recruiting -
AP-HP _St Antoine
Paris, France Recruiting -
CHU de Rouen
Rouen, France Recruiting
Study contacts
- Principal investigator: Federica DEFENDI — University Hospital, Grenoble
- Study coordinator: Federica DEFENDI, PhD
- Email: fdefendi@chu-grenoble.fr
- Phone: +33(0)0476765416
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.