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

NCT05304091 | Withdrawn

• 2 other identifiers: 2021_052021-A02400-41
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Bradykinin-mediated Angioedema

Keywords

Bradykinin; Angioedema; Smartphone; Application; Attack; Hereditary angioedema

Outcome Measures

Primary Outcomes (1)

• Average number of bradykinin-mediated angioedema attacks

  Follow up during 1 year

Secondary Outcomes (6)

• The average number of attack by time of year (months, seasons)

  Follow up during 1 year

• The average duration of an attack episode

  Follow up during 1 year

• The average duration between two attacks

  Follow up during 1 year

• Number of stable clusters of patients that may be drawn out of the data based on attack rhythmicity measures and characteristics of these clusters in each and every cluster.

  After a year of follow up

• Individual number of crisis

  After a year of follow up

Study Arms (1)

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

Other: Questionnaire on a smartphone application

Interventions

Questionnaire on a smartphone application 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.

Patients with bradykinin-mediated angioedema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

MeSH Terms

Conditions

Angioedema; Angioedemas, Hereditary

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes

Study Officials

• Sébastien SANGES, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 31, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: December 26, 2025

Record last verified: 2025-02