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Hereditary Hemorrhagic Telangiectasia (HHT)NCT02464644

Frequency of Common Medical Conditions in People With and Without HHT

A study testing Questionnaire in people with Hereditary Hemorrhagic Telangiectasia (HHT), run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hereditary Hemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people. The purpose of this study is to provide data regarding the frequency of common health conditions and the tolerability of therapies in HHT by using a questionnaire. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,174 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2012to May 2015
Phase
Interventional
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

Who may be able to join

  • Aged 18 or over.
  • Capacity to fill in a questionnaire.

Who cannot join

  • Age under 18
  • Unable to fill in a questionnaire

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • NHLI Cardiovascular Sciences, Imperial College London

    London, SL9 0QR

Other trials in United Kingdom

About this study

Official title: A Questionnaire Study on Hereditary Hemorrhagic Telangiectasia (HHT) and Other Medical Conditions, Compared to the General Population

Hereditary Hemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people. The purpose of this study is to provide data regarding the frequency of common health conditions and the tolerability of therapies in HHT by using a questionnaire.

This will be filled in by both people with HHT, and controls who will be members of the general population without HHT.

The questionnaire has been designed primarily for web based entry, but can also be circulated in paper format on request

Read the detailed description

Hereditary Hemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people, usually causing nosebleeds, skin blood spots, and/or anemia as a result of bleeding from the nose or gut. The majority of people with HHT also have abnormal blood vessels (arteriovenous malformations) in internal organs such as the lungs, liver and brain. Management of this multisystem disorder is highly challenging.

The Lead Applicant has spent 20 years working on this rare disease, and identified multiple areas where more evidence is required to assist clinicians and patients with this lifelong condition. A particular issue is what happens when people with HHT have other common medical conditions such as asthma, cancer, diabetes, or heart disease. Do they have the same pattern of problems as the general population? Can they use the same drugs? Are further safeguards needed? For these important questions, current advice can only be based on theoretical considerations and anecdotal data.

The ultimate goal of this study is to use information derived from a questionnaire to provide evidence to assist clinicians treating people with HHT.

Data will be entered from April 2012. Data will be analysed on average 6-8 months after entry.

Being tested
Questionnaire
Keywords
On-line Questionnaire, No travel, Health, Medicines, Drugs, Lifestyle, Family, Help for others, Rare condition, General population
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

    Also called Survey, Confidential, SurveyMonkey SSL encryption feature, Web-link collector does not collect IP addresses

    To capture large sufficiently large numbers of individuals for appropriate statistical power (see below), a web based questionnaire design was considered the most appropriate tool. SurveyMonkey was identified as the most suitable means to generate the questionnaire, facilitate confidential answers by the target populations, and for analysis of questionnaire data. The designed survey can also be presented in paper format, and used in our clinical service.

Study groups in NCT02464644
Study groupRoleWhat they receive
People with HHTExperimentalPeople with HHT will identify themselves within the questionnaire, first by statement of what they think is their diagnosis, and second by provision of the HHT diagnostic criteria within specific questions. They will be directed to appropriate questions, according to answers to the previous questions.
Receives: Other: Questionnaire
Controls without HHTOtherPeople without HHT will identify themselves within the questionnaire, first by statement of what they think is their diagnosis, and second by provision of the HHT diagnostic criteria within specific questions. They will be directed to appropriate questions, according to answers to the previous questions.
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of nosebleeds.

    The data outcome will be captured at the time of reporting by study participants, indicating the % of respondents affected by nosebleeds at that time. Subsequent calculations will standardise for age and other participant variables.

    Measured: Day 1

Secondary outcomes (1)

  1. Efficacy of nosebleed treatments

    The data outcome will be captured at the time of reporting by study participants, indicating the % of respondents reporting beneficial, null or detrimental effects from nosebleed treatments. Subsequent calculations will standardise for age and other participant variables.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2015 (estimated)
  2. Study startApr 2012
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2,174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02464644
Sponsor's protocol ID
CLS/2012/2
Status last verified
Sep 2023
First submitted
30 Apr 2012
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Silva BM, Hosman AE, Devlin HL, Shovlin CL. Lifestyle and dietary influences on nosebleed severity in hereditary hemorrhagic telangiectasia. Laryngoscope. 2013 May;123(5):1092-9. doi: 10.1002/lary.23893. Epub 2013 Feb 12.

    PubMed 23404156

  • Devlin HL, Hosman AE, Shovlin CL. Antiplatelet and anticoagulant agents in hereditary hemorrhagic telangiectasia. N Engl J Med. 2013 Feb 28;368(9):876-8. doi: 10.1056/NEJMc1213554. No abstract available.

    PubMed 23445111

  • Finnamore H, Le Couteur J, Hickson M, Busbridge M, Whelan K, Shovlin CL. Hemorrhage-adjusted iron requirements, hematinics and hepcidin define hereditary hemorrhagic telangiectasia as a model of hemorrhagic iron deficiency. PLoS One. 2013 Oct 16;8(10):e76516. doi: 10.1371/journal.pone.0076516. eCollection 2013.

    PubMed 24146883

  • Hosman AE, Devlin HL, Silva BM, Shovlin CL. Specific cancer rates may differ in patients with hereditary haemorrhagic telangiectasia compared to controls. Orphanet J Rare Dis. 2013 Dec 20;8:195. doi: 10.1186/1750-1172-8-195.

    PubMed 24354965

  • Elphick A, Shovlin CL. Relationships between epistaxis, migraines, and triggers in hereditary hemorrhagic telangiectasia. Laryngoscope. 2014 Jul;124(7):1521-8. doi: 10.1002/lary.24526. Epub 2014 Jan 23.

    PubMed 24458873

  • Shovlin CL, Awan I, Cahilog Z, Abdulla FN, Guttmacher AE. Reported cardiac phenotypes in hereditary hemorrhagic telangiectasia emphasize burdens from arrhythmias, anemia and its treatments, but suggest reduced rates of myocardial infarction. Int J Cardiol. 2016 Jul 15;215:179-85. doi: 10.1016/j.ijcard.2016.04.006. Epub 2016 Apr 7.

    PubMed 27116331

  • Patel T, Elphick A, Jackson JE, Shovlin CL. Injections of Intravenous Contrast for Computerized Tomography Scans Precipitate Migraines in Hereditary Hemorrhagic Telangiectasia Subjects at Risk of Paradoxical Emboli: Implications for Right-to-Left Shunt Risks. Headache. 2016 Nov;56(10):1659-1663. doi: 10.1111/head.12963. Epub 2016 Oct 11.

    PubMed 27727478

  • Shovlin CL, Patel T, Jackson JE. Embolisation of PAVMs reported to improve nosebleeds by a subgroup of patients with hereditary haemorrhagic telangiectasia. ERJ Open Res. 2016 Apr 29;2(2):00035-2016. doi: 10.1183/23120541.00035-2016. eCollection 2016 Apr.

    PubMed 27730189

  • Shovlin CL, Gilson C, Busbridge M, Patel D, Shi C, Dina R, Abdulla FN, Awan I. Can Iron Treatments Aggravate Epistaxis in Some Patients With Hereditary Hemorrhagic Telangiectasia? Laryngoscope. 2016 Nov;126(11):2468-2474. doi: 10.1002/lary.25959. Epub 2016 Apr 23.

    PubMed 27107394

  • Hosman AE, Shovlin CL. Cancer and hereditary haemorrhagic telangiectasia. J Cancer Res Clin Oncol. 2017 Feb;143(2):369-370. doi: 10.1007/s00432-016-2298-x. Epub 2016 Nov 11.

    PubMed 27837281

Questions about this trial

What is this clinical trial studying?

A study testing Questionnaire in people with Hereditary Hemorrhagic Telangiectasia (HHT), run by Imperial College London at 1 site in United Kingdom.

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 2 inclusion and 2 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 28 Sep 2023. 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 United Kingdom. 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?

Prevalence of nosebleeds. (time frame: Day 1). 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 NCT02464644, which also lists 10 linked publications.

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 28 Sep 2023.

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