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

NCT04763577 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 243

Last updated 2025-02-25

No results posted yet for this study

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.

Conditions

  • Angio-Oedema Caused by Angiotensin-Converting-Enzyme Inhibitor

Interventions

OTHER

Assay of Bradykinin-degradating enzymes.

Aminopeptidase P activity assay; Dipeptidyl peptidase IV activity assay; Angiotensin Converting Enzyme activity assay; MME gene polymorphisme exploration.

Sponsors & Collaborators

  • University Hospital, Paris

    collaborator OTHER

  • University Hospital, Rouen

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Federica DEFENDI · University Hospital, Grenoble

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2025-10-26
Completion
2025-10-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04763577 on ClinicalTrials.gov