Bradykinin-degradating Enzymes Activities in Angiotensin-Converting Enzyme Inhibitors-associated Angioedema
NCT ID: NCT04763577
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
243 participants
OBSERVATIONAL
2021-10-27
2025-10-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Assay of Bradykinin-degradating enzymes.
Aminopeptidase P activity assay; Dipeptidyl peptidase IV activity assay; Angiotensin Converting Enzyme activity assay; MME gene polymorphisme exploration.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Paris
OTHER
University Hospital, Rouen
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Federica DEFENDI
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Chu Grenoble Alpes
Grenoble, , France
CHRU de Lille _Hôpital Claude-Huriez
Lille, , France
AP-HP _St Antoine
Paris, , France
CHU de Rouen
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-A00775-34
Identifier Type: OTHER
Identifier Source: secondary_id
38RC19.025
Identifier Type: -
Identifier Source: org_study_id
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