Suicide Ideation in Hereditary Angioedema (HAE-SAFE)

Suicidal Ideation in Hereditary Angioedema

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicidal Ideation; Cardiovascular Risk; Hereditary Angioedema (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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ivan Cherrez, MD, MSc.; Phone Number: +593 999981769; Email: ivancherrez@gmail.com
• Study Contact Backup: Name: Gabriela Rodas, MD.; Phone Number: +593 969115353; Email: gaby.rodasv@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with a confirmed diagnosis of hereditary angioedema who are treated at specialized centers in Latin America

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of suicide ideation severity as assessed by the Suicidal Ideation Attributes Scale (SIDAS)	SIDAS measures five attributes of suicidal thoughts. Each attribute is scored on a 10-point scale, with total SIDAS scores ranging from 0 to 50. A score of 0= No ideation, 1-20= Low ideation, 21-50= High ideation .	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participant with an increased triglyceride glucose-body mass (TyG-BMI) index	The TyG-BMI index will be obtained using the following formula: ln[TG (mg/dL) × FPG (mg/dL)/2] × BMI (kg/m^2), where TG represents for triglycerides and FBG represents for fasting blood glucose.	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)	A cut-off value of 10 points is used to differentiate patients with poor controlled angioedema from those with well-controlled disease	Day 1
Number of patients with severe disease as assessed by the Hereditary Angioedema Activity Score: HAE-AS	A total score of 12 points will be used as a cutoff for severe disease	Day 1
Number of patients with anxiety or depression as assessed by the Hospital Anxiety and Depression Scale (HADS)	HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression.	Day 1

Collaborators and Investigators

• Sponsor: Ivan Cherrez Ojeda

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: cardiovascular risk; Hereditary Angioedema; Suicidal ideation; TyG-BMI
• Additional Relevant MeSH Terms: Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Immune System Diseases; Behavioral Symptoms; Hypersensitivity, Immediate; Hypersensitivity; Immunologic Deficiency Syndromes; Self-Injurious Behavior; Skin Diseases; Urticaria; Skin Diseases, Vascular; Suicide; Suicidal Ideation; Angioedema; Angioedemas, Hereditary
• Other Study ID Numbers: 2022-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be made available upon reasonable request to the principal investigato

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No