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

Angio Edema Clinical Trial

— BRADYDIAG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963634
• Other study ID #: 2020_59
• Secondary ID: 2020-A03306-33
• Status: Recruiting
• Start date: January 22, 2022
• Est. completion date: January 2026

Study information

• Verified date: April 2022
• Source: University Hospital, Lille
• Contact: David Launay, MD,PhD
• Phone: 0320445962
• Email: david.launay[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Group 1 : Patients with bradykinin angioedema
• Patient with biologically proven hereditary angioedema with C1 inhibitor deficiency,
• Or a patient with bradykinin angioedema related to a plasminogen or factor XII mutation,
• Or patients with bradykinin angioedema related to ACE inhibitors or ARB2,
• Or patient with acquired bradykinin angioedema due to C1 inhibitor deficiency,
• Age > or = 18 years with the capacity to understand the requirements of the study and to give a non-opposition
• Having a blood collection scheduled as part of routine care
• Being insured by social security Group 2 : Patients with histamine-mediated angioedema
• Patient with idiopathic histamine angioedema as determined by the referring physician
• Age > or = 18 years with the capacity to understand the requirements of the study and to give a non-opposition
• Having a blood collection scheduled as part of routine care
• Being insured by social security

Exclusion Criteria:

• Minors or protected adults,
• Pregnant or breastfeeding woman,
• Person deprived of liberty,
• Person in an emergency situation,
• Person having refused or unable to give their non-opposition

Related Conditions & MeSH terms

• Angio Edema
• Angioedema

Intervention

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).

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare measurement by proteomics of proteins differentially expressed in the plasma by ANOVA t test	to evaluate the contribution of a plasma proteomic signature including albumin, gammaglobulin and alpha macroglobulin the plasma proteome of two group: Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)	through study completion an average of 1 year
Secondary	analyze the following biomarkers for diagnostic purposes in both groups.	analyze the following biomarkers for diagnostic purposes: C1 inhibitor quantity	Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)
Secondary	the value of plasma proteome markers and the markers mentioned above as predictors of the occurrence of attacks		at 1 year
Secondary	Implementation of a biobank to identify future biomarkers		Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)