Suicide Ideation in Hereditary Angioedema (HAE-SAFE)

Ivan Cherrez Ojeda

Status: Not yet enrolling

Conditions: Suicidal Ideation; Cardiovascular Risk; Hereditary Angioedema (HAE)

Study type: Observational

Funder types: Other

Identifiers

NCT06811467

2022-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

HAE-SAFE 1

Description:

Patients with a diagnosis of hereditary angioedema confirmed by decreased C1-INH levels and/or decreased C1-INH activity or genomic sequencing