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Characterization of Rhythmicity Profiles of Bradykinin-mediated Angioedema Attacks Using a Tracking Smartphone Application.

NCT ID: NCT05304091

Last Updated: 2022-03-31

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-31

Study Completion Date

2023-08-31

Brief Summary

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Bradykinin-mediated angioedema is a rare and disabling disease, characterized by the occurrence of attacks marked by localized swelling of skin, but also of the airways, which can be life-threatening. The unpredictable nature of attacks is a key feature of angioedema, placing patients under constant threat. It seems that there are different patterns of yearly distribution for these attacks, but this is poorly described in the literature. The objectives of the study are to establish different rhythmicity profiles of patients according to the frequency of the attacks; and to identify factors potentially triggering the attacks. For this purpose, patients with bradykinin-mediated angioedema will be monitored daily using a smartphone application. Each day, the application will ask the patient if he or she is having an attack and, if so, the characteristics of the attack and the events preceding it

Detailed Description

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Conditions

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Bradykinin-mediated Angioedema

Keywords

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Bradykinin Angioedema Smartphone Application Attack Hereditary angioedema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with bradykinin-mediated angioedema

Patients with bradykinin-mediated angioedema, aged 18 years or older, followed in the internal medicine department of the Lille University Hospital

Questionnaire on a smartphone application

Intervention Type OTHER

Each day, the smartphone application will ask the patient if he or she is having an angioedema attack. It not, the questionnaire will stop. If the patient is having an attack, a series of 5 short questions is asked about the attack characteristics and the events that preceded it.

Interventions

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Questionnaire on a smartphone application

Each day, the smartphone application will ask the patient if he or she is having an angioedema attack. It not, the questionnaire will stop. If the patient is having an attack, a series of 5 short questions is asked about the attack characteristics and the events that preceded it.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of bradykinin-mediated angioedema
* Age \> 18
* Having a smartphone
* Non opposition to answer the questionnaire

Exclusion Criteria

* Patients with other type (histaminergic) angioedema
* Patient unable or unwilling to use a smartphone application
* Opposition to the research
* Minor or protected adult
* Person deprived of liberty
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien SANGES, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Central Contacts

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Sébastien SANGES, MD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Other Identifiers

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2021-A02400-41

Identifier Type: OTHER

Identifier Source: secondary_id

2021_05

Identifier Type: -

Identifier Source: org_study_id