Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05100420 |
Other study ID # |
MP-33-2021-2872 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 23, 2021 |
Est. completion date |
August 23, 2027 |
Study information
Verified date |
October 2023 |
Source |
Montreal Heart Institute |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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). The HiRO Hypertrophic Cardiomyopathy registry, biobank and
imaging data repository (HiRO-HCM) is a multicenter study that will prospectively enroll
patients with HCM as well as those carrying sarcomeric gene variants predisposing to HCM.
The objectives of HiRO-HCM are:
1. to better understand the natural history of the disease and identify clinical markers
and biomarkers for adverse outcomes;
2. to derive and validate risk prediction models for disease expression, complications and
response to therapy;
3. to better define the genetic architecture of sarcomeric and non-sarcomeric HCM.
Description:
PATIENT ENROLLMENT:
Eligible patients will be included from HiRO sites or collaborating centres. Patients will be
contacted by the local investigator or a research coordinator. Willing individuals will be
interviewed by the research coordinator and given information about HiRO-HCM. The consent
form will be reviewed and discussed with the coordinator. The investigators will also be
available for any questions that the coordinator is unable to answer. Potential participants
will have sufficient time to consider participating in HiRO-HCM. Written informed consent
will be obtained from eligible patients or legal guardians. Participants will be able to
withdraw their participation at any time.
BASELINE DATA COLLECTION:
Clinical data will be collected from willing/consented registry participants. All demographic
and medical information pertaining to the cardiac history and comorbidities of eligible
patients will be collected at baseline, including clinical information, diagnostic test
results, genetic testing results, family history and ethnicity, as well as current and
previous treatments. Healthcare information will be coded in compliance with Canada's
Tri-Council Policy Statement criteria: direct identifiers will be removed and replaced with a
unique study code that does not use personal information such as the participant's health
number, social insurance number or name. The coded data will be transferred into the clinical
research database using a web-based electronic case report form (eCRF), using REDcap. The
clinical research database will be managed by the Montreal Health Innovations Coordinating
Center (MHICC; mhicc.org). Study participants will be identified by subject number only
(research HiRO-HCM ID). The research ID uniquely identifying each subject eCRF within the
database will be attributed in REDcap but the master list of registry participants with their
study identifiers will be kept separately from the clinical research database. This master
list will be stored in an encrypted file within the research office of each site
investigators under their supervision. Only the site investigators and their local research
staff will have access to this list.
BIOSPECIMEN COLLECTION:
Consented participants will undergo biosampling at enrollment for the primary purpose of DNA
isolation and genetic studies. The preferred biosampling method is blood sampling using a
standard venipuncture. Blood sampling allows for high quality DNA extraction as well as
collection of plasma for future circulating biomarkers studies. As an alternative to blood
sampling, collection of saliva using DNA genotek kits, or equivalent, is allowed in the
following contexts:
- Patient enrollment is performed remotely. This is particularly relevant in the context
of the ongoing SARS-CoV-2 pandemic, where physical distancing is preferred.
- Patient is a child <14 years old without planned clinically indicated blood sampling.
Participants for which saliva collection is chosen should be made aware of the possibility to
request a blood sample in the future.
The HiRO-HCM biobank will be directed by the Beaulieu-Saucier Pharmacogenomics Center (PGx;
http://www.pharmacogenomics.ca), operating under Good Laboratory/Clinical Practices (GLP/GCP)
standards.
DNA isolation and long-term storage will be done at PGx, while long-term storage of plasma
samples will be done at the MHI research center, in dedicated freezers located in a room with
restricted access. Samples of subjects that withdraw their participation will be destroyed.
IMAGING DATA TRANSFER:
For all consented participants, de-identified transthoracic echocardiography (TTE) and
cardiac magnetic resonance (CMR) imaging data will be transferred to the Montreal Heart
Institute imaging core-lab for central interpretation and long term storage. At minimum, the
following imaging studies are requested:
1. First available TTE
2. First available CMR, preferably with gadolinium injection
3. Last available TTE
4. Last available CMR, preferably with gadolinium injection
For patients that underwent alcohol septal ablation, surgical myectomy and/or cardiac
transplantation, the last available TTE and CMR studies prior to all these interventions
should also be transferred.
Digital Imaging and Communications in Medicine (DICOM) imaging data will be de-identified
prior to transfer. De-identification will be performed at each site, by removing the
patient's name and replacing the clinical identification number with the research HiRO-HCM
ID. DICOM data will be stored using the Canadian Imaging network infrastructure
(canadianimagingnetwork.org).
PATIENT FOLLOW-UP:
Participants with a clinical diagnosis of HCM are expected to undergo yearly clinic visits,
as per standard care. Participants without yearly clinic visits will be contacted by phone.
Follow-up visits will assess for living status, functional class, as well as for arrhythmic,
heart failure and thromboembolic events. Follow-up data will be entered by the local
investigator and/or research coordinator into an eCRF managed by the MHICC. De-identified
documentation of clinical events including ECG, intracardiac tracing, clinical notes, imaging
reports, and procedural reports will be uploaded to the database for centralized ad-hoc event
adjudication.
De-identified DICOM images of TTE and CMR studies performed clinically during follow-up will
be uploaded to the MHI imaging core-lab similarly as for baseline imaging studies.
For participants that will undergo septal myectomy for drug-refractory obstructive HCM, or
cardiac transplantation, surgical tissue samples will be collected using the Qiagen PAXgene
tissue preservation system or equivalent, allowing for future somatic DNA, RNA and proteomic
analyses. The samples will be stored at the MHI research center.