Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema (MONOBRAD)
Primary Purpose
Hereditary Bradykinetic Angioedema
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Explorations
Blood samples
Sponsored by
About this trial
This is an interventional other trial for Hereditary Bradykinetic Angioedema
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.
Sites / Locations
- DRCIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients hereditary bradykinetic angioedema
healthy volunteers
Arm Description
Outcomes
Primary Outcome Measures
compare the gene expression of B1 and / or B2 monocyte receptors
compare between patients with hereditary bradykinetic angioedema and control subjects.
Secondary Outcome Measures
Full Information
NCT ID
NCT04032002
First Posted
July 22, 2019
Last Updated
October 16, 2019
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT04032002
Brief Title
Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema
Acronym
MONOBRAD
Official Title
Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Bradykinetic Angioedema
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients hereditary bradykinetic angioedema
Arm Type
Other
Arm Title
healthy volunteers
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Explorations
Intervention Description
On Day 1 vascular fonctions explorations performed
Intervention Type
Other
Intervention Name(s)
Blood samples
Intervention Description
On Day 1 35ml taken
Primary Outcome Measure Information:
Title
compare the gene expression of B1 and / or B2 monocyte receptors
Description
compare between patients with hereditary bradykinetic angioedema and control subjects.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
DRCI
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David MALLET
Phone
0232888265
Email
secretariat.drc@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Guillaume ARMENGOL
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients With Hereditary Bradykinetic Angioedema
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