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WithdrawnNCT05304091ANGIOAPPUpdated Dec 26, 2025

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

An observational study in Bradykinin-mediated Angioedema, sponsored by University Hospital, Lille. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by University Hospital, Lille · Observational

Why this study was withdrawn
DEFAULT INCLUSION
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Bradykinin-mediated Angioedema

Keywords

  • Bradykinin
  • Angioedema
  • Smartphone
  • Application
  • Attack
  • Hereditary angioedema
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In context

Angioedema

69 studies on the registry are indexed under Angioedema; 16 are open to participants now.

Browse Angioedema studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherQuestionnaire 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.

06

What researchers measure

Primary outcomes

  1. Average number of bradykinin-mediated angioedema attacks

    Time frame: Follow up during 1 year

Secondary outcomes

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

    Time frame: Follow up during 1 year

  2. The average duration of an attack episode

    Time frame: Follow up during 1 year

  3. The average duration between two attacks

    Time frame: Follow up during 1 year

  4. 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.

    Number of stable clusters of patients that may be drawn out of the data based on attack rhythmicity measures (based on the number of attacks, the average duration of an attack episode, and the average duration between two attacks) and characteristics of these clusters (mean and standard deviation of rhythmicity measures) in each and every cluster. Stability and information metrics grounding the choice of the number of clusters and their analysis: * Bootstrapped Jaccard stability index of clusters, and its 95% confidence interval * Silhouette value of the clustering * Share of intra-cluster variance

    Time frame: After a year of follow up

  5. Individual number of crisis

    Descriptif between patient's characteristics ( age, sex, disease onset and treatments) and Individual attack rhythmicity measures(secondary outcome measures n°2) Coefficients (with 95% intervals and Wald test p-values) and pseudo-R² of a Poisson regression modeling the individual number of crisis based on age, sex, disease onset and treatments.

    Time frame: After a year of follow up

  6. Type of attack triggering events

    In the application ,question is : "In the 48 hours preceding the onset of the crisis, did you identify one or more of the following events? (several answers possible) Multiple choice can be one or more between Physical activity; Local trauma (blow, injury ...); Dental or surgical procedure; Psychological stress or emotion; Infection; Periods / menstruation; Medication; Other (specify).

    Time frame: After a year of follow up

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2022; primary completion for Aug 2023, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2022
First posted
Mar 31, 2022
StartEst.
Aug 2022
Primary completionEst.
Aug 2023
CompletionEst.
Aug 2023
Last update
Dec 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05304091
Responsible party
Sponsor
First posted
Mar 31, 2022
Start date
Aug 2022 (estimated)
Primary completion
Aug 2023 (estimated)
Completion
Aug 2023 (estimated)
Last update
Dec 26, 2025

Study contacts

Sébastien SANGES, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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