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NCT04763577: KIN-ACE
Bradykinin-degradating Enzymes Activities in Angiotensin-Converting Enzyme Inhibitors-associated Angioedema
trial testing Assay of Bradykinin-degradating enzymes. in Angio-Oedema Caused by Angiotensin-Converting-Enzyme Inhibitor in 243 participants. Currently enrolling.
26 October 2025
Quick facts
| Lead sponsor | University Hospital, Grenoble |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 243 |
| Start date | 27 October 2021 |
| Primary completion | 26 October 2025 |
| Estimated completion | 26 October 2025 |
| Sites | 4 locations across France |
Drugs / interventions tested
- Assay of Bradykinin-degradating enzymes.
Conditions studied
- Angio-Oedema Caused by Angiotensin-Converting-Enzyme Inhibitor — all drugs for Angio-Oedema Caused by Angiotensin-Converting-Enzyme Inhibitor →
Sponsor
University Hospital, Grenoble
Who can join
18 and older, any sex, with Angio-Oedema Caused by Angiotensin-Converting-Enzyme Inhibitor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04763577 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Grenoble
- Last refreshed: 25 February 2025
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