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

NCT ID: NCT04032002

Last Updated: 2019-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2021-09-30

Brief Summary

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

Detailed Description

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Conditions

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Hereditary Bradykinetic Angioedema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients hereditary bradykinetic angioedema

Group Type OTHER

Explorations

Intervention Type OTHER

On Day 1 vascular fonctions explorations performed

Blood samples

Intervention Type OTHER

On Day 1 35ml taken

healthy volunteers

Group Type OTHER

Explorations

Intervention Type OTHER

On Day 1 vascular fonctions explorations performed

Blood samples

Intervention Type OTHER

On Day 1 35ml taken

Interventions

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Explorations

On Day 1 vascular fonctions explorations performed

Intervention Type OTHER

Blood samples

On Day 1 35ml taken

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).


* 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

* 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
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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DRCI

Rouen, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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David MALLET

Role: primary

0232888265

Other Identifiers

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2018/349/HP

Identifier Type: -

Identifier Source: org_study_id

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