Suicide Ideation in Hereditary Angioedema

NCT ID: NCT06811467

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-09-30

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.

Conditions

Hereditary Angioedema (HAE); Suicidal Ideation; Cardiovascular Risk

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

HAE-SAFE 1

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ivan Cherrez Ojeda

OTHER

Sponsor Role: lead

Responsible Party

Ivan Cherrez Ojeda

Adjunct Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Ivan Cherrez, MD, MSc.

Role: CONTACT

ivancherrez@gmail.com

+593 999981769

Gabriela Rodas, MD.

Role: CONTACT

gaby.rodasv@hotmail.com

+593 969115353

Other Identifiers

2022-006

Identifier Type: -

Identifier Source: org_study_id