Suicide Ideation in Hereditary Angioedema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hereditary Angioedema (HAE), Suicidal Ideation, Cardiovascular Risk. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Suicidal Ideation in Hereditary Angioedema
Overview
This study focuses on patients with Hereditary Angioedema (HAE) to better understand how mental health affects overall well-being. Through a questionnaire, the investigators will assess the presence of suicidal thoughts, anxiety, and depression, as well as cardiovascular risk markers. By analyzing these factors together, the investigators aim to identify possible links between mental health and heart health in people with HAE. This research will help improve care strategies and highlight the importance of mental well-being in managing HAE.
Detailed description
This observational study focuses on patients with Hereditary Angioedema (HAE) to explore the impact of mental health on overall well-being. Through a questionnaire, the investigators aim to assess not only the presence but also the severity of suicidal thoughts, as well as symptoms of anxiety and depression. Additionally, the investigators will evaluate how these mental health factors relate to disease variables such as HAE control, disease activity, and quality of life.
Beyond mental health, the investigators also seek to understand its connection to cardiovascular risk factors. By measuring triglycerides, glucose levels, and body mass index (BMI), the investigators aim to explore whether patients with higher suicide risk also face increased heart health risks. This research will help improve patient care by emphasizing the importance of both mental and physical health in managing HAE. After identifying patients with high risk of suicide ideation the investigators will conduct a folow-up study after patients have received mental health interventions and how evaluate how treatment can determine better HAE outcomes. With these resuts the investigators expect to attract the attention of the international scientific community to increase early detection and effective solutions to prevent suicide.
Primary outcome measures
- Presence of suicide ideation severity as assessed by the Suicidal Ideation Attributes Scale (SIDAS) [Time frame: Day 1]
Secondary outcome measures (4)
- Number of participant with an increased triglyceride glucose-body mass (TyG-BMI) index [Time frame: In the previous 12 weeks or up to 12 weeks after enrollment]
- Number of patients with uncontrolled disease as assessed by the Angioedema Control Test (AECT) [Time frame: Day 1]
- Number of patients with severe disease as assessed by the Hereditary Angioedema Activity Score: HAE-AS [Time frame: Day 1]
- Number of patients with anxiety or depression as assessed by the Hospital Anxiety and Depression Scale (HADS) [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- Confirmed diagnosis of hereditary angioedema
- Over the age of 18
Exclusion criteria
- Patients with intellectual disability
- Refusal to participate in the study
- Patients with acquired C1-INH deficiency
- Patients with other dermatological diseases.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06811467 · 2022-006