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

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

Study Overview

• Status: Completed
• Conditions: Hereditary Bradykinetic Angioedema
• Intervention / Treatment: Other: Explorations; Other: Blood samples

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76000
    • DRCI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (patients):

• 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
• Effective contraception in women of childbearing age (negative pregnancy test). For postmenopausal women, a confirmatory diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit).

Inclusion Criteria (volunteers):

• Person affiliated with a social security scheme
• Person who read and understood the newsletter and signed the consent form
• Effective contraception in women of childbearing age (negative pregnancy test). For postmenopausal women, a confirmation diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit)

Exclusion Criteria (patients):

• 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.

Exclusion Criteria (volunteers)

• 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
• Person participating or having participated in another therapeutic trial within one week.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: healthy volunteers	Other: Explorations; On Day 1 vascular fonctions explorations performed; Other: Blood samples; On Day 1 35ml taken
Other: Patients hereditary bradykinetic angioedema	Other: Explorations; On Day 1 vascular fonctions explorations performed; Other: Blood samples; On Day 1 35ml taken

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare the gene expression of B1 and / or B2 monocyte receptors	compare between patients with hereditary bradykinetic angioedema and control subjects.	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Actual): May 17, 2021
• Study Completion (Actual): May 17, 2021

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Vascular Diseases; Inflammation; Angioedema; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Technology, Industry, and Agriculture; Transportation; Aviation; Blood Specimen Collection; Space Flight
• Other Study ID Numbers: 2018/349/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No