NCT04963634

Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The unpredictable nature of the attacks is one of the essential characteristics of bradykinin angioedema. The two main difficulties for physicians managing a patient with bradykinin angioedema are to make the diagnosis and anticipate the severity. Biomarkers can be used to diagnose, guide treatment, or predict the severity of a disease. However, the identification of biomarkers is currently difficult in bradykinin both for diagnosis and prognosis. While measurement of C4 and C1 inhibitor (quantitative and functional assays) allows the diagnosis of bradykinin angioedema due to C1 inhibitor deficiency, whether genetic or acquired, many patients with normal C1 inhibitor bradykinin angioedema, either hereditary or acquired, are still difficult to diagnose. For patients with hereditary angioedema with C1-inhibitor deficiency, there is no biomarker currently available to predict the severity. Any biomarker that could improve the diagnosis on the one hand, and improve the prediction of the frequency and severity of the response to treatment on the other hand, would obviously be extremely useful. The aim of our study is to assess the existence possible biomarkers for diagnosis and prognosis of bradykinin angioedema.

Conditions

• Angio Edema

Interventions

Type	Name	Description
OTHER	Biobanking	For patients included in BRADYDIAG study, 2 blood samples will be collected at enrollment (for group 1: bradykinin angioedema and for group 2: histamine-mediated angioedema) and at 1 year visit (for group 1 only: bradykinin angioedema).

Timeline

• Start date: 2022-01-22
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2021-07-15
• Last updated: 2022-04-12

Locations

1 site across 1 country: France