Status:
UNKNOWN
Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema
Lead Sponsor:
University Hospital, Rouen
Conditions:
Hereditary Bradykinetic Angioedema
Eligibility:
All Genders
18+ years
Phase:
NA
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
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04032002
Start Date
October 1 2019
End Date
September 1 2021
Last Update
October 17 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
DRCI
Rouen, France, 76000