Hereditary Angioedema Clinical Trial
Official title:
Functional Physiological, Psychological and Biochemical Reactivity to Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients
This study aims to evaluate the differences in objective and subjective stress responses between patients with hereditary angioedema and healthy individuals to a stress-induced challenge like socially-evaluated cold pressure test. The study also investigates the role of psychological variables in influencing the stress response.
Stressful encounters, ranging from daily hassles to major life events, are ubiquitous in our everyday lives and are often responsible for significant changes in affective and cognitive processes. In various physical diseases, including hereditary angioedema (HAE) due to C1 inhibitor deficiency, stressful events are also frequently reported by patients to trigger acute attacks. These include physical stress (such as injury, pain, viral infections, medical and dental procedures, and surgery) and mental stress (including stress from life events and school or work, clinical depression, and anxiety), or stress originating from the disease itself, especially if the disease is characterized by an unpredictable nature like HEA that directly impacts patients' choices in everyday life. Available literature related to the link between HAE and stress is limited and mainly focused on the patients' narratives. Self-reported data suggested that the main HAE trigger seems to be stress, followed by physical trauma. These observations suggest analyzing the perceived psychological effects consequent to stress exposure together with biochemical and physiological responses. The effect of stress could be systematically examined in a laboratory environment using a standardized protocol that reliably induces stress and activates major stress responses in experimental contexts. A reliable test to induce stress in HAE patients combining these two aspects may be the Socially Evaluated Cold Pressor Test (SECPT). SECPT is an extension of the classical Cold Pressor Test, in which participants immerse one of their hands in ice water with socio-evaluative elements, and has been proven to be a highly efficient tool for experimental stress induction in humans. Adding social-evaluative elements to the original physical stress boosted the cortisol response, making the SECPT a well-established standard protocol in human stress research that may represent an efficient alternative to other established protocols, such as the Trier Social Stress Test, a 'gold standard' in the field. A recent review confirmed that exposure to the SECPT leads to changes in subjective feeling, and triggers a significant sharp increase in systolic and diastolic blood pressure. The present study aims to evaluate objective and subjective stress responses between HAE patients and healthy controls due to SECPT. Moreover, as secondary aims, the study wants to investigate if the presence of anxiety and depressive symptoms, as well as body appreciation, trust in the body, pain catastrophizing, pain interference, and pain intensity, affect or mediate stress response in patients and healthy subjects similarly or differently. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT06007677 -
A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
|
Phase 2 | |
Completed |
NCT00997204 -
EASSI - Evaluation of the Safety of Self-Administration With Icatibant
|
Phase 3 | |
Completed |
NCT00438815 -
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
|
Phase 3 | |
Completed |
NCT00748202 -
Berinert P Study of Subcutaneous Versus Intravenous Administration
|
Phase 3 | |
Completed |
NCT01426763 -
A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase
|
Phase 2 | |
Terminated |
NCT04091113 -
Hereditary Angioedema Kininogen Assay
|
||
Completed |
NCT00432510 -
Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
|
Phase 1 | |
Completed |
NCT03712228 -
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
|
Phase 2 | |
Active, not recruiting |
NCT05453968 -
Berotralstat Treatment in Children With Hereditary Angioedema
|
Phase 3 | |
Recruiting |
NCT05505916 -
An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
|
Phase 3 | |
Recruiting |
NCT05511922 -
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
|
Phase 3 | |
Not yet recruiting |
NCT02159430 -
Hereditary AngioEdema, Neurobiology and Psychopathology
|
N/A | |
Completed |
NCT02303626 -
12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks
|
Phase 2/Phase 3 | |
Completed |
NCT01984788 -
Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE
|
Phase 2 | |
Completed |
NCT04888650 -
Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema
|
||
Completed |
NCT02448264 -
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers
|
Phase 1 | |
Completed |
NCT05118958 -
Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations
|
Phase 1 | |
Active, not recruiting |
NCT04739059 -
Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
|
Phase 3 | |
Completed |
NCT02819102 -
An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates
|
Phase 1 | |
Completed |
NCT01679912 -
A Call Center During HAE Attacks (SOS HAE)
|
Phase 4 |