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
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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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-10-31
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patients hereditary bradykinetic angioedema
Explorations
On Day 1 vascular fonctions explorations performed
Blood samples
On Day 1 35ml taken
healthy volunteers
Explorations
On Day 1 vascular fonctions explorations performed
Blood samples
On Day 1 35ml taken
Interventions
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Explorations
On Day 1 vascular fonctions explorations performed
Blood samples
On Day 1 35ml taken
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
ALL
Yes
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Locations
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DRCI
Rouen, , France
Countries
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Facility Contacts
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Other Identifiers
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2018/349/HP
Identifier Type: -
Identifier Source: org_study_id
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