Bradykinin-mediated AngioedemaANGIOAPPNCT05304091
Characterization of Rhythmicity Profiles of Bradykinin-mediated Angioedema Attacks Using a Tracking Smartphone Application.
An observational study of Bradykinin-mediated Angioedema, run by University Hospital, Lille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradykinin-mediated Angioedema
- What is being tested?
- Questionnaire on a smartphone application
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bradykinin-mediated angioedema, aged 18 years or older, followed in the internal medicine department of the Lille University Hospital.
Who may be able to join
- Diagnosis of bradykinin-mediated angioedema
- Age > 18
- Having a smartphone
- Non opposition to answer the questionnaire
Who cannot join
- 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
About this study
Official title: Rhythmicity Profiles of Bradykinin-mediated Angioedema.
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
- Being tested
- Questionnaire on a smartphone application
- Keywords
- Bradykinin, Angioedema, Smartphone, Application, Attack, Hereditary angioedema
- Medical subject headings
- Angioedema, Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire on a smartphone applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Questionnaire on a smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of bradykinin-mediated angioedema attacks
Measured: Follow up during 1 year
Secondary outcomes (6)
The average number of attack by time of year (months, seasons)
Measured: Follow up during 1 year
The average duration of an attack episode
Measured: Follow up during 1 year
The average duration between two attacks
Measured: 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.
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
Measured: After a year of follow up
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.
Measured: After a year of follow up
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).
Measured: After a year of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study startAug 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Why it stopped: DEFAULT INCLUSION
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bradykinin-mediated AngioedemaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien SANGES, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304091
- Sponsor's protocol ID
- 2021_05
- Other IDs
- 2021-A02400-41
- Acronym
- ANGIOAPP
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythmicity Profiles of Bradykinin-mediated Angioedema.
- ClinicalTrials.gov ID
- NCT05304091
- Acronym / sponsor ID
- ANGIOAPP / 2021_05
- Conditions
- Bradykinin-mediated Angioedema
- Keywords
- Bradykinin, Angioedema, Smartphone, Application, Attack, Hereditary angioedema
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: DEFAULT INCLUSION
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bradykinin-mediated angioedema | – | Other: Questionnaire on a smartphone applicationPatients with bradykinin-mediated angioedema, aged 18 years or older, followed in the internal medicine department of the Lille University Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bradykinin-mediated angioedema, aged 18 years or older, followed in the internal medicine department of the Lille University Hospital.
Key inclusion criteria (4 listed)
- Diagnosis of bradykinin-mediated angioedema
- Age > 18
- Having a smartphone
- Non opposition to answer the questionnaire
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire on a smartphone applicationEach 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. | Other | Patients with bradykinin-mediated angioedema |
Primary outcome
Average number of bradykinin-mediated angioedema attacks
Time frame: Follow up during 1 year
6 secondary outcomes
The average number of attack by time of year (months, seasons)
Time frame: Follow up during 1 year
The average duration of an attack episode
Time frame: Follow up during 1 year
The average duration between two attacks
Time frame: 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.
Time frame: After a year of follow up
Individual number of crisis
Time frame: After a year of follow up
Type of attack triggering events
Time frame: After a year of follow up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
Related trials for Bradykinin-mediated Angioedema
RecruitingPhase 1/2
Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
Hereditary Angioedema (HAE), Angioedema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien SANGES, MD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
An observational study of Bradykinin-mediated Angioedema, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of bradykinin-mediated angioedema attacks (time frame: Follow up during 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.