Clinical trial NCT04032002: Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema
Official title: Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hereditary Bradykinetic Angioedema
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: compare the gene expression of B1 and / or B2 monocyte receptors
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: DRCI
Study officials:
References: