Clinical trial NCT06811467: Suicide Ideation in Hereditary Angioedema
Official title: Suicidal Ideation in Hereditary Angioedema
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hereditary Angioedema (HAE)
Suicidal Ideation
Cardiovascular Risk
Keywords: Hereditary Angioedema
Suicidal ideation
TyG-BMI
cardiovascular risk
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a confirmed diagnosis of hereditary angioedema who are treated at specialized centers in Latin America

Brief summary: 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.

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.

Primary outcomes:
measure: Presence of suicide ideation severity as assessed by the Suicidal Ideation Attributes Scale (SIDAS)
timeFrame: Day 1
Secondary outcomes:
measure: Number of participant with an increased triglyceride glucose-body mass (TyG-BMI) index
timeFrame: In the previous 12 weeks or up to 12 weeks after enrollment
measure: Number of patients with uncontrolled disease as assessed by the Angioedema Control Test (AECT)
timeFrame: Day 1
measure: Number of patients with severe disease as assessed by the Hereditary Angioedema Activity Score: HAE-AS
timeFrame: Day 1
measure: Number of patients with anxiety or depression as assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Day 1
Other outcomes:
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