Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients

NCT06414252 | Completed

• 1 other identifier: 2774CE
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hereditary Angioedema

Keywords

Hereditary Angioedema; Autonomic nervous system; Cold pressor test; Stress; Body appreciation; Rare disease

Outcome Measures

Primary Outcomes (6)

• Heart rate

  Changes in the heart rate (beats per minute) from resting to SECPT condition

  Baseline

• Systolic arterial pressure

  Changes in the systolic blood pressure (mmHg) from resting to SECPT condition

  Baseline

• Diastolic arterial pressure

  Changes in the systolic blood pressure (mmHg) from resting to SECPT condition

  Baseline

• Visual Analogue Scale of perceived stress

  Changes in the perceived stress due to SECP. Scores ranges from 0 (no stress) to 100 (worst stress possible)

  Baseline

• Concentration of inflammatory cytokines

  Changes in the concentration of inflammatory cytokines (pg/ml) due to SECPT

  Baseline

• Concentration of plasma cathecolamines

  Changes in the concentration of plasma cathecolamines (pg/ml) due to SECPT

  Baseline

Secondary Outcomes (6)

• Hospital Anxiety and Depression Scale

  Baseline

• Perceived Stress Scale (PSS-10)

  Baseline

• Multidimensional Assessment of Interoceptive Awareness Version 1

  Baseline

• Body Appreciation Scale-2 (BAS-2)

  Baseline

• Functionality Appreciation Scale (FAS)

  Baseline

Study Arms (2)

Patients with hereditary angioedema

Patients with documented diagnosis of hereditary angioedema due to C1 inhibitor deficiency and aged between 18 and 65 years.

Healthy individuals

Healthy individuals with an age between 18 and 65 and matched with patients with hereditary angioedema by age and gender.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The group of patients with hereditary angioedema were recruited during an out-patient visit in a tertiary care center. The group of healthy individuals were volunteers recruited from community.

You may qualify if:

• Documented diagnosis of hereditary angioedema due to C1 inhibitor deficiency aged between 18 and 65 years (for the group of patients)

You may not qualify if:

• Any type of chronic disease requiring chronic treatment (i.e. hypertension, previous myocardial infarction, diabetes, chronic heart failure, autoimmune disease, neurodegenerative disease)
• Active acute disease;
• Sars-Cov2 infection in the previous 3 months.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Milan, 20138, Italy

Location

Related Publications (1)

• De Maria B, Ranucci L, Gino C, Cesoni Marcelli A, Zingale LC, Zulueta A, Dalla Vecchia LA, Gorini A, Perego F. Functional physiological, psychological, and biochemical reactivity to socially evaluated cold pressor test in hereditary angioedema patients (FRoSEn). Front Immunol. 2026 Jan 7;16:1736589. doi: 10.3389/fimmu.2025.1736589. eCollection 2025.

  PMID: 41573571 DERIVED

MeSH Terms

Conditions

Angioedemas, Hereditary; Rare Diseases

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 16, 2024
• Study Start: May 15, 2023
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

IT (1)