Symptoms and Treatment Results in Hereditary Hemorrhagic Telangiectasia

Hereditary Haemorrhagic Telangiectasia (HHT) Clinical Trial

Official title:

A Questionnaire Based Study on Symptoms and Treatment Results in Hereditary Hemorrhagic Telangiectasia (HHT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690246
• Other study ID #: University Clinic Essen
• Status: Completed
• Start date: April 2014
• Est. completion date: March 2021

Study information

• Verified date: March 2022
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and visceral arteriovenous malformations. The purpose of this study is to provide data about multiple clinical aspects of HHT and responses to treatment. For comparison of some aspects also data of non-affected relatives is collected (second cohort). the questionnaire has been designed primarily for web based entry, but can also be circulated in paper format on request.

Description:

Specific aspects include potential consequences from iron deficiency, efficacy and safety of self-packing, effect of female sex hormones, mortality, effects on the immune system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 915
• Est. completion date: March 2021
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a diagnosis of Hereditary Haemorrhagic Telangiectasia

Exclusion Criteria:

• unable to provide informed consent

Related Conditions & MeSH terms

• Hereditary Haemorrhagic Telangiectasia (HHT)
• Telangiectasia, Hereditary Hemorrhagic
• Telangiectasis

Intervention

Other:
• questionnaire
a questionnaire based study

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with restless legs syndrome according to a questionnaire including the criteria by Allen et al., Sleep Medicine 4(2003) 101-119		34 months
Other	Number of infectious diseases and complications in comparison to healthy spouses		34 months
Other	Hormonal changes: Change of number of visible telangiectases during menstrual cycle and pregnancy		34 months
Primary	Effect of nasal self-packing to treat epistaxis on the quality of life in patients with HHT measured mainly by Glasgow Benefit Inventory (GBI)	Hereditary Haemorrhagic Telangiectasia is characterised by recurrent epistaxis which can lead to a feeling to lose control. The investigators examine whether the use of high volume low pressure nasal packing is a secure and practical method to improve patients' quality of life.	34 months
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		34 months

External Links

•   The Englisch version of the questionnaire can be reached by the following URL: https://www.surveymonkey.com/r/hhtquestions
•   The German version of the questionnaire can be reached by the following URL: https://www.surveymonkey.com/r/morbusosler