Autonomic Nervous System Profile in Hereditary Angioedema

NCT06408805 | Completed

• 1 other identifier: 2746CE
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare the autonomic nervous system control of patients with hereditary angioedema to healthy individuals. The main questions it aims to answer are: Are there differences in the autonomic nervous system control between patients with hereditary angioedema and healthy individuals during short-term resting period and during orthostatic challenges? Are there differences in the autonomic nervous system control recorded over long-term periods (i.e. 24 hours)?

Conditions

Hereditary Angioedema

Keywords

Hereditary angioedema; Heart Rate Variability; Autonomic Nervous System; Rare disease

Outcome Measures

Primary Outcomes (1)

• Short-term heart rate variability

  Changes in heart rate variability indices analyzed during tilt test

  Baseline

Secondary Outcomes (2)

• Long-term heart rate variability

  Baseline

• Concentration of catecholamines

  Baseline

Study Arms (2)

Patients with hereditary angioedema

Patients with documented diagnosis of hereditary angioedema due to C1 inhibitor deficiency with or without prophylactic treatment 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
• Healthy Volunteers: Yes
• 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 a out-patient visit in a tertiary care center. The group of healthy individuals were volunteers recruited from community.

You may qualify if:

• Age between 18 and 65 years
• Diagnosis of hereditary angioedema due to C1 inhibitor deficiency (for the group of patients only)

You may not qualify if:

• Any type of chronic diseases requiring chronic treatment.
• Active acute disease
• Sars-Cov2 infection in the previous three months
• Acute attacks experiences within the previous week and within 72 hours after the enrollment
• Patients in prophylaxis treated off-label.

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, Zulueta A, Parati M, Cesoni Marcelli A, Zingale LC, Sideri R, Dalla Vecchia LA, Perego F. Cardiac and vascular autonomic control in patients with hereditary angioedema. Front Physiol. 2025 Dec 16;16:1690915. doi: 10.3389/fphys.2025.1690915. eCollection 2025.

  PMID: 41476578 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 10, 2024
• Study Start: July 12, 2023
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

IT (1)