Hereditary AngioEdema, Neurobiology and Psychopathology (HAENP)

June 5, 2014 updated by: Prof. Eugenio Aguglia, University Hospital, Catania
Since 1963 Hereditary AngioEdema (HAE) is considered an autosomal dominant disorder (Donaldson and Evans), characterized by a quantitative and/or qualitative deficit of C1 esterase inhibitor (C1-INH), which affects approximately 1:50.000 individuals in the general population. From this period the link between HAE and psychiatry was interrupted, however genetic issues could not comprehensively explain the clinical evolution of the disease. Clinical studies show an evident gap between genotype and phenotype of HAE. For this still controversial question, we have designed this cross-sectional study in order to establish the relationship between HAE clinical manifestations and neurobiological/psychopatological parameters.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catania, Italy, 95024
        • UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This population-based cross-sectional study will include all Hereditary AngioEdema (HAE) patients from the Eastern Sicily HAE register.

Description

Inclusion Criteria:

Diagnosis of HAE

Exclusion Criteria:

  • Current pharmacological treatment including ACE-inhibitors, ACE inhibitors, glucocorticoids, oestroprogestative, psychotropic drugs, drugs acting on the immune system (15 days before), anesthetics (in the previous three months).
  • Inflammation / infection (eg, chronic inflammatory diseases, acute) in the last 15 days.
  • Ongoing allergies.
  • Night work over the past 15 days.
  • Vigorous physical activity or alcohol consumption (the day before the assessment).
  • Women in follicular phase of menstrual cycle.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HereditaryAngioEdema
Patients from the Eastern Sicily HAE register
Other: Clinical and psychopathological assessment of HAE patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Multivariate linear regression analysis of HAE clinical status and psychometric parameters
Time Frame: First assessment
First assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Catania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 5, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHCatania1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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