Hereditary Angioedema (HAE)HAE-SAFENCT06811467
Suicide Ideation in Hereditary Angioedema
An observational study of Hereditary Angioedema (HAE) and Suicidal Ideation, run by Ivan Cherrez Ojeda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Angioedema (HAE), Suicidal Ideation, Cardiovascular Risk
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a confirmed diagnosis of hereditary angioedema who are treated at specialized centers in Latin America
Who may be able to join
- Confirmed diagnosis of hereditary angioedema
- Over the age of 18
Who cannot join
- Patients with intellectual disability
- Refusal to participate in the study
- Patients with acquired C1-INH deficiency
- Patients with other dermatological diseases.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Keywords
- Hereditary Angioedema, Suicidal ideation, TyG-BMI, cardiovascular risk
- Medical subject headings
- Angioedemas, Hereditary, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Day 1
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Angioedema (HAE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ivan Cherrez Ojeda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ivan Cherrez Ojeda, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811467
- Sponsor's protocol ID
- 2022-006
- Acronym
- HAE-SAFE
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available upon reasonable request to the principal investigato
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicidal Ideation in Hereditary Angioedema
- ClinicalTrials.gov ID
- NCT06811467
- Acronym / sponsor ID
- HAE-SAFE / 2022-006
- Keywords
- Hereditary Angioedema, Suicidal ideation, TyG-BMI, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ivan Cherrez OjedaUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a confirmed diagnosis of hereditary angioedema who are treated at specialized centers in Latin America
Key inclusion criteria (2 listed)
- Confirmed diagnosis of hereditary angioedema
- Over the age of 18
Key exclusion criteria (4 listed)
- Patients with intellectual disability
- Refusal to participate in the study
- Patients with acquired C1-INH deficiency
- Patients with other dermatological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 .
4 secondary outcomes
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
Number of patients with uncontrolled disease as assessed by the Angioedema Control Test (AECT)
Time frame: Day 1
Number of patients with severe disease as assessed by the Hereditary Angioedema Activity Score: HAE-AS
Time frame: Day 1
Number of patients with anxiety or depression as assessed by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No. Data will be made available upon reasonable request to the principal investigato
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Angioedema (HAE) and Suicidal Ideation, run by Ivan Cherrez Ojeda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Cherrez, MD, MSc. (+593 999981769, ivancherrez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of suicide ideation severity as assessed by the Suicidal Ideation Attributes Scale (SIDAS) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.