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NCT Number: NCT06811467

Suicide 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.

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Key information

Conditions

Hereditary Angioedema (HAE) Angioedema Angioedemas, Hereditary Behavior Behavioral Symptoms Cardiovascular Diseases Cardiovascular Risk Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Self-Injurious Behavior Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Suicidal Ideation Suicide Urticaria Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Presence of suicide ideation severity as assessed by the Suicidal Ideation Attributes Scale (SIDAS)

    Time frame: Day 1

    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 .

Secondary outcomes

  1. Number of participant with an increased triglyceride glucose-body mass (TyG-BMI) index

    Time frame: In the previous 12 weeks or up to 12 weeks after enrollment

    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.

  2. Number of patients with uncontrolled disease as assessed by the Angioedema Control Test (AECT)

    Time frame: Day 1

    A cut-off value of 10 points is used to differentiate patients with poor controlled angioedema from those with well-controlled disease

  3. Number of patients with severe disease as assessed by the Hereditary Angioedema Activity Score: HAE-AS

    Time frame: Day 1

    A total score of 12 points will be used as a cutoff for severe disease

  4. Number of patients with anxiety or depression as assessed by the Hospital Anxiety and Depression Scale (HADS)

    Time frame: Day 1

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela Rodas, MD.

CONTACT

[email protected]

+593 969115353

Ivan Cherrez, MD, MSc.

CONTACT

[email protected]

+593 999981769

Sponsors and collaborators

Lead sponsor

Ivan Cherrez Ojeda

Other

Registry information

Official study title

Suicidal Ideation in Hereditary Angioedema

Acronym: HAE-SAFE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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