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

U

University Hospital, Rouen

Status

Unknown

Conditions

Hereditary Bradykinetic Angioedema

Treatments

Other: Blood samples
Other: Explorations

Study type

Interventional

Funder types

Other

Identifiers

NCT04032002
2018/349/HP

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Patients hereditary bradykinetic angioedema
Other group
Treatment:
Other: Explorations
Other: Blood samples
healthy volunteers
Other group
Treatment:
Other: Explorations
Other: Blood samples

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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