Viewing Study NCT06811467


Ignite Creation Date: 2025-12-25 @ 12:27 AM
Ignite Modification Date: 2025-12-25 @ 10:32 PM
Study NCT ID: NCT06811467
Status: NOT_YET_RECRUITING
Last Update Posted: 2025-02-10
First Post: 2025-01-31
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Suicide Ideation in Hereditary Angioedema
Sponsor: Ivan Cherrez Ojeda
Organization:

Study Overview

Official Title: Suicidal Ideation in Hereditary Angioedema
Status: NOT_YET_RECRUITING
Status Verified Date: 2025-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HAE-SAFE
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: