Hereditary Haemorrhagic Telangiectasia (HHT)NCT02690246
Symptoms and Treatment Results in Hereditary Hemorrhagic Telangiectasia
An observational study of Hereditary Haemorrhagic Telangiectasia (HHT), run by University Hospital, Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Haemorrhagic Telangiectasia (HHT)
- What is being tested?
- questionnaire
- How many people
- 915 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with HHT; Indirectly we accept healthy volunteers only as control cohort in questionnaires of affected persons.
Who may be able to join
- a diagnosis of Hereditary Haemorrhagic Telangiectasia
Who cannot join
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Questionnaire Based Study on Symptoms and Treatment Results in Hereditary Hemorrhagic Telangiectasia (HHT)
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.
Read the detailed 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.
- Being tested
- questionnaire
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
a questionnaire based study
| Study group | Role | What they receive |
|---|---|---|
| patients with HHT | patients with Hereditary Haemorrhagic Telangiectasia Receives: Other: questionnaire | |
| control cohort | indirectly only as a control cohort in questionnaire of affected persons |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 34 months
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startApr 2014
- Primary completionAug 2019
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary Haemorrhagic Telangiectasia (HHT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 915 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Urban Geisthoff, University Hospital, Essen
- Investigators
- Urban Geisthoff, Prof. Dr., Study director, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690246
- Sponsor's protocol ID
- University Clinic Essen
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2016
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Droege F, Thangavelu K, Koeninger A, Huessler EM, Lang S, Stuck BA, Geisthoff UW. Influence of hormonal status in hereditary hemorrhagic telangiectasia - analysis of an online patient questionnaire. BMC Pregnancy Childbirth. 2026 Mar 20;26(1):388. doi: 10.1186/s12884-026-08928-2.
PubMed 41862858
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Questionnaire Based Study on Symptoms and Treatment Results in Hereditary Hemorrhagic Telangiectasia (HHT)
- ClinicalTrials.gov ID
- NCT02690246
- Acronym / sponsor ID
- University Clinic Essen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 915 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with HHT | – | Other: questionnairepatients with Hereditary Haemorrhagic Telangiectasia |
| control cohort | – | –indirectly only as a control cohort in questionnaire of affected persons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HHT; Indirectly we accept healthy volunteers only as control cohort in questionnaires of affected persons.
Key inclusion criteria (1 listed)
- a diagnosis of Hereditary Haemorrhagic Telangiectasia
Key exclusion criteria (1 listed)
- unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairea questionnaire based study | Other | patients with HHT |
Primary outcome
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.
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 34 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 41862858Droege F, Thangavelu K, Koeninger A, Huessler EM, Lang S, Stuck BA, Geisthoff UW. Influence of hormonal status in hereditary hemorrhagic telangiectasia - analysis of an online patient questionnaire. BMC Pregnancy Childbirth. 2026 Mar 20;26(1):388. doi: 10.1186/s12884-026-08928-2.
- Individual participant dataSharing planned: Undecided
Related trials for Hereditary Haemorrhagic Telangiectasia (HHT)
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
RecruitingObservational study
Quality of Life in Pediatric Participants With HHT
Hereditary Haemorrhagic Telangiectasia (HHT)
Not yet recruitingObservational study
Prevalence of Obstructive Sleep Apnea in HHT and HHT-specific Challenges in OSA-therapy - a Retrospective Cohort Study
Hereditary Hemorrhagic Telangiectasia (HHT), Obstructive Sleep Apnea (OSA)
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urban Geisthoff, Prof. Dr. study director
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Haemorrhagic Telangiectasia (HHT), run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02690246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.