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Enrolling by invitation NCT06261333

Quality of Life in Patients With Hemorrhagic Telangiectasia

Observational Hereditary Hemorrhagic Telangiectasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires.
Who it may be relevant to
Registry conditions: Hereditary Hemorrhagic Telangiectasia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Influence of Telangiectasia and Anemia on the Well-being and Quality of Life of Patients With Hereditary Hemorrhagic Telangiectasia (HHT).

Overview

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.

Interventions

  • Other Questionnaires
    No Intervention

Primary outcome measures

  • Quality of Life and Patient Satisfaction measured using the FACE-Questionnaire [Time frame: one year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

-Individuals not meeting the inclusion criteria.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Departement of Otorhinolaryngology - Head and Neck Surgery University Hospital Essen — Essen

Identifiers

NCT: NCT06261333 · 23-11519-BO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗