Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema

NCT04032002 | Completed

• 1 other identifier: 2018/349/HP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to compare the gene expression of B1 and / or B2 monocyte receptors between patients with hereditary bradykinetic angioedema and control subjects.

Conditions

Hereditary Bradykinetic Angioedema

Outcome Measures

Primary Outcomes (1)

• compare the gene expression of B1 and / or B2 monocyte receptors

  compare between patients with hereditary bradykinetic angioedema and control subjects.

  Day 1

Study Arms (2)

Patients hereditary bradykinetic angioedema

OTHER

Other: Explorations; Other: Blood samples

healthy volunteers

OTHER

Other: Explorations; Other: Blood samples

Interventions

Explorations OTHER

On Day 1 vascular fonctions explorations performed

Patients hereditary bradykinetic angioedema; healthy volunteers

Blood samples OTHER

On Day 1 35ml taken

Patients hereditary bradykinetic angioedema; healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with inherited bradykinic angioedema due to quantitative or qualitative C1-inhibitor deficiencies, regardless of the frequency or severity of seizures and regardless of their background treatment, with the following diagnostic criteria:
• C1-inhibitor rate \<50% of normal
• Repeated episodes characteristic of bradykinic angioedema
• Hereditary nature of the disease.
• Person who read and understood the newsletter and signed the consent form
• Person affiliated with a social security scheme
• Person affiliated with a social security scheme
• Person who read and understood the newsletter and signed the consent form

You may not qualify if:

• Angioedema crisis less than 1 month old
• Chronic inflammatory disease such as rheumatoid arthritis or Crohn's disease.
• Acute infection in progress, with or without anti-infectious treatment
• Contraindication to the use of trinitrin:
• Hypersensitivity to nitrates or to any of the excipients
• shock, severe hypotension,
• obstructive cardiomyopathy,
• inferior court inferior myocardial infarction with right ventricular extension, except in case of evidence of left ventricular failure,
• intracranial hypertension,
• patient treated with sildenafil
• Pregnant or parturient or breastfeeding woman or lack of proven contraception
• Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-tutorship or curatorship
• Patient participating or having participated in another therapeutic trial within one week.
• Chronic inflammatory disease such as rheumatoid arthritis or Crohn's disease.
• Acute infection in progress, with or without anti-infectious treatment

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

DRCI

Rouen, 76000, France

Location

MeSH Terms

Interventions

Space Flight; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Aviation; Transportation; Technology, Industry, and Agriculture; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 25, 2019
• Study Start: November 10, 2020
• Primary Completion: May 17, 2021
• Study Completion: May 17, 2021
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)