NCT04763577 Bradykinin-degradating Enzymes Activities in Angiotensin-Converting Enzyme Inhibitors-associated Angioedema
| NCT ID | NCT04763577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Grenoble |
| Condition | Angio-Oedema Caused by Angiotensin-Converting-Enzyme Inhibitor |
| Study Type | OBSERVATIONAL |
| Enrollment | 243 participants |
| Start Date | 2021-10-27 |
| Primary Completion | 2025-10-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 243 participants in total. It began in 2021-10-27 with a primary completion date of 2025-10-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Angiotensin-Converting-Enzyme-inhibitors-dependent angioedema (ACEi-AE) is the most frequent form of bradykinin-mediated AE, with an estimated prevalence of 0.1% to 0.7%. These AE can be explained by the accumulation of bradykinin (BK), a peptide responsible for increase of vascular permeability: ACE inhibitors block ACE, the main inactivation pathway of the BK, thus extending its half-life. In spite of the the stopping of the drug, systematically performed in the case of ACEi-AE, up to 50% of patients relapsed within 6 months, with maximum risk in the first month after stopping. In addition, the discontinuation of these drugs represents a loss of chance for some patients, without clearly established mastocytic (or histaminic) or bradykinic etiology. At present there is no method to predict the risk of crisis recurrence in patients who have developed AE-IEC. The investigators hypothesize that the risk of relapse is associated with a decrease in the activity of BK degradation enzymes (including aminopeptidase P (APP), dipeptidyl peptidase-4 (DPP4), and ECA) that persists at the cessation of IEC.
Eligibility 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
Contact & Investigator
Federica DEFENDI
PRINCIPAL INVESTIGATOR
University Hospital, Grenoble
Frequently Asked Questions
Who can join the NCT04763577 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Angio-Oedema Caused by Angiotensin-Converting-Enzyme Inhibitor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04763577 currently recruiting?
Yes, NCT04763577 is actively recruiting participants. Contact the research team at fdefendi@chu-grenoble.fr for enrollment information.
Where is the NCT04763577 trial being conducted?
This trial is being conducted at Grenoble, France, Lille, France, Paris, France, Rouen, France.
Who is sponsoring the NCT04763577 clinical trial?
NCT04763577 is sponsored by University Hospital, Grenoble. The principal investigator is Federica DEFENDI at University Hospital, Grenoble. The trial plans to enroll 243 participants.