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OpenTrials
Completed

NCT Number: NCT04032002

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DRCI

Rouen, 76000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Explorations

Other

On Day 1 vascular fonctions explorations performed

Blood Samples

Other

On Day 1 35ml taken

Primary outcomes

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

    Time frame: Day 1

    compare between patients with hereditary bradykinetic angioedema and control subjects.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: MONOBRAD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 25, 2019
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.