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

Last updated: February 24, 2025
Sponsor: University Hospital, Grenoble
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy

Hives (Urticaria)

Urticaria

Treatment

Assay of Bradykinin-degradating enzymes.

Clinical Study ID

NCT04763577
38RC19.025
2020-A00775-34
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women at least 18 years old

  • Presenting AE secondary to treatment with Angiotensin Conversion Enzyme Inhibitorsfor less than 15 days, or an isolated AE (without superficial hives), which lasts atleast 15 hours, and whose diagnosis is validated by the expert committee,

  • Having signed informed and written consent

  • And being affiliated with social security

Exclusion

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 exclusionfrom another research involving the human person type 1 or 2 Persons referred to insections L1121-5 to L1121-8 of the public health code (pregnant woman, breastfeedingmother, person deprived of liberty, person subject to legal protection) subject thatcannot be contacted in an emergency situation

Study Design

Total Participants: 243
Treatment Group(s): 1
Primary Treatment: Assay of Bradykinin-degradating enzymes.
Phase:
Study Start date:
October 27, 2021
Estimated Completion Date:
October 26, 2025

Connect with a study center

  • Chu Grenoble Alpes

    Grenoble, 38043
    France

    Active - Recruiting

  • CHRU de Lille _Hôpital Claude-Huriez

    Lille, 59037
    France

    Active - Recruiting

  • AP-HP _St Antoine

    Paris, 75571
    France

    Active - Recruiting

  • CHU de Rouen

    Rouen, 76 031
    France

    Active - Recruiting

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