Quality of Life in Patients With Hemorrhagic Telangiectasia

NCT ID: NCT06261333

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-22

Study Completion Date

2025-12-31

Brief Summary

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Hereditary Hemorrhagic Telangiectasia (HHT), also known as Osler's disease, is a genetic disorder that leads to abnormal blood vessel formations. It primarily affects blood vessels in the skin, mucous membranes, and internal organs. The disease can be clinically diagnosed using the Curaçao criteria (1. Positive family history of HHT, 2. Recurrent and spontaneous epistaxis, 3. Multiple typical telangiectasias, 4. Organ involvement with vascular malformations, especially in the liver, lungs, gastrointestinal tract, or brain); if a patient meets at least 3 criteria, the diagnosis of HHT can be established.

Patients with HHT often have telangiectasias on their faces. Additionally, many patients suffer from anemia, which can result in a pale and potentially tired appearance. Patients with HHT may be less satisfied with their appearance due to the aesthetic changes in their faces and may also experience psychosocial impairment. To further investigate this, various validated questionnaires (FACE-Q©, PROMIS-Profile-29+2, EQ5D), as well as routinely collected clinical data (e.g., laboratory values including hemoglobin levels, Curaçao criteria, smoking status, alcohol consumption, and the Epistaxis Severity Score (ESS)) will be used.

Detailed Description

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Conditions

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Hereditary Hemorrhagic Telangiectasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaires

No Intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* knowledge of german language
* Age above 17 years
* capable of giving consent
* Diagnosis of HHT (Curaçao criteria or genetic testing)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Essen

OTHER

Sponsor Role lead

Responsible Party

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Freya Droege

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Departement of Otorhinolaryngology - Head and Neck Surgery University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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23-11519-BO

Identifier Type: -

Identifier Source: org_study_id

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