An observational study in Hereditary Angioedema (HAE), Suicidal Ideation and Cardiovascular Risk, sponsored by Ivan Cherrez Ojeda. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Ivan Cherrez Ojeda · Observational
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.
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.
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 43 observational studies indexed under Angioedemas, Hereditary.
Browse Angioedemas, Hereditary studies →This is the only study on the registry with Ivan Cherrez Ojeda as lead sponsor.
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Patients with a confirmed diagnosis of hereditary angioedema who are treated at specialized centers in Latin America
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Exclusion Criteria:
Patients with a diagnosis of hereditary angioedema confirmed by decreased C1-INH levels and/or decreased C1-INH activity or genomic sequencing
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 .
Time frame: Day 1
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Day 1
No study locations are listed for this record.
Plan to share: No — Data will be made available upon reasonable request to the principal investigato
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for Aug 2025, 5 months later.
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This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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