NCT04189822Enrolling by invitation
Hearts in Rhythm Organization (HiRO)National Registry and Bio Bank
Hearts in Rhythm Organization (HiRO)National Registry and Bio Bank: Improving Detection and Treatment of Inherited Heart Rhythm Disorders to Prevent Sudden Death
Source: ClinicalTrials.gov · Last updated 3 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The Hearts in Rhythm Organization (HiRO) is a national network of Canadian researchers/clinicians, working towards a better understanding of the rare genetic causes of sudden cardiac death (SCD). Canadian adult and pediatric electrophysiology centres across Canada work together to gather data and bio sample in a national data registry and bio bank hoping to improve the detection and treatment of inherited heart rhythm disorders to prevent sudden death.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 18 Nov 2019
- Start date
- 27 Aug 2019
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of British Columbia
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT04189822
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 27 Aug 2019 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- All Canadian patients referred for cardiac investigations related to inherited heart rhythm (IHR) conditions will be invited to participate if they meet the following criteria:
- They understand the registry/bio bank purpose, potential risks and willingly sign consent
- Recognized genetic syndromes; Long QT syndrome (LQT), Short QT Syndrome (SQT), catecholaminergic polymorphic ventricular tachycardia (CPVT), Brugada (BrS), Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC), Familial Cardiac Conduction Disease (FCCD).
- Deceased cases of SCD, suspicious for an inherited heart rhythm condition. Included with signed consent from next of kin (NOK).
- IHR patients referred for risk of SCD enrolled (includes first degree and second degree relatives) SCD syndromes seen in heart rhythm clinics; Unexplained cardiac arrest (UCA), Early Repolarization (ER), Idiopathic Ventricular Fibrillation (IVF), Short Coupled IVF (SCIF), Polymorphic Ventricular Tachycardia Not Otherwise Diagnosed (PMVT, NYD), Sudden Arrhythmic Death Syndromes (SADS) that are SCD cases with negative autopsy results.
- Mendelian cardiomyopathies (hypertrophic cardiomyopathy (HCM), Mendelian Dilated Cardiomyopathy (DCM) including Lamin and Phosopholambin (LMNA, \& PLN), and Left Ventricular Non -Compaction (LVNC).
- \*\*Must have either a probable or definite clinical diagnosis, first degree relative (FDR) with a known diagnosis, gene carrier (disease causing or likely disease causing by American College of Medical Genetics (ACMG 2015), or may be second degree relative (SDR) with inability to screen intervening relative
- Carriers of a pathogenic or likely-pathogenic variant for an inherited arrhythmia or cardiomyopathy related gene, not otherwise fitting inherited or cardiomyopathy diagnostic criteria
- Exclusion:
- Patients referred for cardiac investigations related to inherited heart rhythm conditions will be excluded from participating if they meet the following criteria:
- Unwilling or are unable to provide informed consent
- Known sarcoidosis
- Mitral valve Prolapse unless unexplained cardiac arrest or syncope with documented PMVT
- Heart Failure/Non-Familial Dilated Cardiomyopathy DCM without a positive family history of affected FDRs or SDRs
- Aortopathies including Marfan Syndrome, Ehlers Danlos, Familial Thoracic Aortic Aneurysm and Dissection
- Neuromuscular disease
- Familial hypercholesterolemia
Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of British Columbia/St. Paul's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.