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OpenTrials
Completed

NCT Number: NCT02690246

Symptoms and Treatment Results in Hereditary Hemorrhagic Telangiectasia

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.

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Key information

Conditions

Hereditary Haemorrhagic Telangiectasia (HHT) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Telangiectasia, Hereditary Hemorrhagic Telangiectasis Vascular Diseases Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Essen

Essen, 45147, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a diagnosis of Hereditary Haemorrhagic Telangiectasia

Exclusion criteria

  • unable to provide informed consent

Treatment and study plan

Questionnaire

Other

a questionnaire based study

Primary outcomes

  1. Effect of nasal self-packing to treat epistaxis on the quality of life in patients with HHT measured mainly by Glasgow Benefit Inventory (GBI)

    Time frame: 34 months

    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.

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 34 months

Other outcomes

  1. Number of patients with restless legs syndrome according to a questionnaire including the criteria by Allen et al., Sleep Medicine 4(2003) 101-119

    Time frame: 34 months

  2. Number of infectious diseases and complications in comparison to healthy spouses

    Time frame: 34 months

  3. Hormonal changes: Change of number of visible telangiectases during menstrual cycle and pregnancy

    Time frame: 34 months

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2021
First posted
Feb 24, 2016
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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