Suicide Ideation in Hereditary Angioedema
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIvan Cherrez Ojeda
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of hereditary angioedema
Over the age of 18
Disqualifiers
Patients with intellectual disability
Refusal to participate in the study
Patients with acquired C1-INH deficiency
Patients with other dermatological diseases.
Trial population
Patients with a confirmed diagnosis of hereditary angioedema who are treated at specialized centers in Latin America
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: HAE-SAFE 1
Trial outcomes
Primary outcomes
1
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 1Secondary outcomes
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 enrollment2
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 13
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 14
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 1Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ivan Cherrez Ojeda
Lead sponsor
Charite University, Berlin, Germany
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: