Hereditary Bradykinetic Angioedema Clinical Trial
— MONOBRADOfficial title:
Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema
| Verified date | July 2019 |
| Source | University Hospital, Rouen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective is to compare the gene expression of B1 and / or B2 monocyte receptors between patients with hereditary bradykinetic angioedema and control subjects.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | September 2021 |
| Est. primary completion date | September 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | DRCI | Rouen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Rouen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | compare the gene expression of B1 and / or B2 monocyte receptors | compare between patients with hereditary bradykinetic angioedema and control subjects. | Day 1 |