Epidemiological Analysis for Hereditary Angioedema Disease

NCT ID: NCT03558009

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2318 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2022-04-11

Brief Summary

An international, multicenter, epidemiological, observational study investigating the prevalence of Hereditary Angioedema (HAE) disease among participants with recurrent episodes of abdominal pain of no obvious etiology.

Detailed Description

Hereditary Angioedema (HAE) is a rare autosomal dominant disorder characterized most commonly by deficient (type 1) or nonfunctional (type 2) C1 inhibitor protein (encoded by SERPING1 gene). The disorder is associated with episodes of angioedema of the face, larynx, lips, abdomen, and extremities. The angioedema is caused by the activation of the kallikrein-kinin system that leads to the release of vasoactive peptides, followed by edema, which in severe cases can be life threatening.

Gastrointestinal involvement occurs in 93% of patients with HAE and may be the only manifestation of the disease. However, individuals with gastrointestinal symptoms are rarely considered for HAE and the disease can be misdiagnosed for several years.

EHA study focuses on the gastrointestinal complications of HAE as a potential area of misdiagnosis leading to surgical morbidity. Aim of the study is to investigate the prevalence of HAE among participants experiencing recurrent abdominal pain attacks with no clear etiology. The HAE-positive samples in the study will be further analyzed biochemically to identify disease-specific biomarker that may support the development of new diagnostic tools for HAE disease.

Conditions

Abdominal Pain; Functional Abdominal Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with abdominal pain attacks

Participants experiencing recurrent abdominal pain attacks without a clear etiolgy aged between 2-60 years

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Informed consent will be obtained from the participant or the parent or legal guardian
• Participants with previous episodes of abdominal pain of no obvious etiology
• Participants aged between 2 to 60 years old

Exclusion Criteria

• Previous diagnosis of HAE
• Inability to provide informed consent
• The etiology of abdominal pain attacks is determined
• Participants that are younger than 2 years old or older than 60 years old
• Previous enrolled in the study

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CENTOGENE GmbH Rostock

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Bauer, MD

Role: STUDY_CHAIR

CENTOGENE GmbH

Locations

Praxis und Tagesklinik Prof. Dr. med. Jens Papke

Neustadt, Saxony, Germany

Universitätsklinikum Düsseldorf, Klinik für Allgemein-, Viszeral- und Kinderchirurgie

Düsseldorf, , Germany

Dr. med. Engelhard | Dr. med. Wihl, Internistische Gemeinschaftspraxis

Frankenberg, , Germany

Universitätsmedizin Greifswald Körperschaft des öffentlichen Rechts

Greifswald, , Germany

Klinikum Kassel GmbH

Kassel, , Germany

Universitätsklinikum Leipzig AöR

Leipzig, , Germany

Johannes Wesling Klinikum Minden, Universitätsklinik der Ruhr Universität Bochum

Minden, , Germany

Kinder- und Jugendklinik, Universitätsmedizin Rostock

Rostock, , Germany

Azienda Ospedaliera Antonio Cardarelli

Napoli, , Italy

Hiroshima University Graduate School of Biomedical Sciences

Hiroshima, , Japan

Gastromed

Bialystok, , Poland

Centrum Medyczne Alfamedica Silesia North

Częstochowa, , Poland

Specialized Medical Offices MeaMedica

Gdansk, , Poland

Przychodnia Polskiej Fundacji Gastroenterologii

Warsaw, , Poland

WIP Warsaw IBD Point

Warsaw, , Poland

Przychodnia Lekarska MediSpace

Warsaw, , Poland

Uniwersytecki Szpital Kliniczny

Wroclaw, , Poland

Cdl "Barska"

Włocławek, , Poland

Cukurova University Balcali Hospital

Adana, , Turkey (Türkiye)

Bezmialem Vakif Üniversitesi

Istanbul, , Turkey (Türkiye)

Ege University Faculty of Medicine

Izmir, , Turkey (Türkiye)

Dokuz Eylül University Research and Application Hospital

Izmir, , Turkey (Türkiye)

Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

University Hospital of Derby and Burton NHS Foundation Trust

Derby, , United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Royal Alexandra Hospital

Glasgow, , United Kingdom

University Hospital Crosshouse

Kilmarnock, , United Kingdom

University Hospital Leicester (UHL)

Leicester, , United Kingdom

The Royal London Hospital

London, , United Kingdom

St Thomas Hospital

London, , United Kingdom

St George's University Hospital London

London, , United Kingdom

Imperial College Healthcare NHS Trust

London, , United Kingdom

Manchester Royal Infirmary

Manchester, , United Kingdom

Milton Keynes Hospital

Milton Keynes, , United Kingdom

Countries

Germany; Italy; Japan; Poland; Turkey (Türkiye); United Kingdom

Other Identifiers

EHA 01-2018

Identifier Type: -

Identifier Source: org_study_id