NCT04150822

Brief Summary

The goal of this study is to better understand HHT, the symptoms and complications it causes ("outcomes") and how the disease impacts people's lives. The investigators are aiming to recruit and gather information together in the Registry from 1,000 HHT patients from four HHT Centres of Excellence in North America. The Investigators will collect long-term information about the people in the Registry, allowing the investigators to understand how the disease changes over time, and what factors can influence those changes. Ultimately, this should help improve treatments for the disease.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Nov 2018Jun 2028

Study Start

First participant enrolled

November 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Expected
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

September 18, 2019

Last Update Submit

April 20, 2026

Conditions

Hereditary Hemorrhagic TelangiectasiaHHTArteriovenous Malformation of Brain

Outcome Measures

Primary Outcomes (2)

  • Prospective and longitudinal characterization of major outcomes of HHT in a cohort of HHT patients, from Centers of Excellence in North America.

    Comprehensive baseline clinical, demographic and lifestyle data will be collected and entered into the recruitment-ready newly developed OUR HHT Registry.

    10 Years

  • The longitudinal characterization of major outcomes of HHT in the North American cohort

    Annual outcome data will be collected and entered into the recruitment-ready newly developed OUR HHT Registry.

    10 Years

Secondary Outcomes (5)

  • Characterizing the determinants of HHT by prospectively and longitudinally measuring the rates of clinical outcome of HHT

    10 Years

  • Epistaxis which affects 90% of adults with HHT, will be characterized by measuring the rates of clinical outcome.

    10 Years

  • The prospective development of organ VMs in HHT patients

    10 Years

  • The rates of venous thromboembolism (VTE) in HHT patients

    10 Years

  • A DNA repository of HHT subjects will be created as a resource for future genetic, pharmacogenetics and targeted therapy studies.

    10 Years

Other Outcomes (1)

  • Participant entered data

    10 Years

Interventions

Registry and Saliva sampleOTHER

Non-interventional registry with saliva sample collected for DNA analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with Hereditary Hemorrhagic Telangiectasia (HHT), living in North America

You may qualify if:

  • Participants diagnosed with HHT by the Curacao criteria (either 3+ clinical diagnostic criteria or genetic diagnosis).
  • Capable of giving informed consent in person or via a substitute decision maker
  • \>18 years

You may not qualify if:

  • Participants unable to give informed consent either in person or with a substitute decision maker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Telangiectasia, Hereditary HemorrhagicArteriovenous Malformations

Interventions

Registries

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesTelangiectasisHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesRecordsOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Marie E Faughnan, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2019

First Posted

November 5, 2019

Study Start

November 1, 2018

Primary Completion

June 23, 2023

Study Completion (Estimated)

June 30, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

CA(1)