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Trial registered on ANZCTR


Registration number
ACTRN12622000772741
Ethics application status
Approved
Date submitted
1/03/2022
Date registered
30/05/2022
Date last updated
30/05/2022
Date data sharing statement initially provided
30/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
NSW HEARTS: The NSW Inherited Cardiomyopathy Cohort Study
Scientific title
NSW HEARTS: The NSW Inherited Cardiomyopathy Cohort Study
Secondary ID [1] 306537 0
None
Universal Trial Number (UTN)
Trial acronym
NSW HEARTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inherited Cardiomyopathy 325421 0
Hypertrophic cardiomyopathy 325485 0
Dilated cardiomyopathy 325486 0
Arrhythmogenic cardiomyopathy 325487 0
Left ventricular noncompaction 325488 0
Restrictive cardiomyopathy 325489 0
Undiagnosed but familial cardiomyopathy 325490 0
Genetically confirmed heritable cardiomyopathy not already eligible 325491 0
Asymptomatic gene carrier 325492 0
Condition category
Condition code
Human Genetics and Inherited Disorders 322812 322812 0 0
Other human genetics and inherited disorders
Cardiovascular 322813 322813 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
NSW HEARTS is a cohort study that aims to recruit over 3000 participants from NSW diagnosed with inherited cardiomyopathies and prospectively follow them over time. The overarching aim of this study is to create a large, well-characterised cohort of patients with inherited cardiomyopathies in NSW for cross-sectional and longitudinal analysis. The project will continue for 10 years, subject to ongoing ethics approval.

Participants involved in this project will have their data collected. Data collected will include clinical information (e.g. medical records from birth or diagnosis to date), cardiac investigations (e.g. digital ECG, echocardiogram reports), blood sample (20ml of whole blood), cardiac magnetic resonance imaging and NSW Health linked data (NSW Emergency Department Data Collection, NSW Admitted Patient Collection, NSW Mortality dataset).

Participants will also be invited to complete some online surveys about their health. This will include a clinical survey, environmental factors survey and health status survey. Each survey will take approximately 15-20mins to complete. The time of survey administration is within the first few months of consent (for all 3 surveys), then on an annual basis (for follow-up clinical survey only) and every 3 years basis after (for all 3 surveys) until the close of the study.

All participants will be asked to have a 20mL blood sample collected from their vein in their arm at a NSW Health Pathology blood collection clinic. Samples will be stored as serum, plasma and DNA at the NSW Health Statewide Biobank. During the study period, all samples will undergo research-based genome sequencing at an accredited sequencing provider. If any clinically actionable variants are identified during the process of genomic testing, the participant and their nominated health professional will be notified of the result. We will also provide a report, either electronic or hardcopy, to participants which will also be sent to their nominated health professional.
Intervention code [1] 322966 0
Diagnosis / Prognosis
Comparator / control treatment
No control group as this is a cohort study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330618 0
Polygenic risk will be assessed through single nucleotide polymorphism (SNP) arrays and consequent statistical analysis, in participants with HCM and DCM to identify how common genetic variation relates to disease risk, severity and outcomes. Participant data will be collected via blood samples for whole genome sequencing.
Timepoint [1] 330618 0
2024
Primary outcome [2] 330619 0
Whole genome sequencing will be performed on all participants where a blood sample is available. This is for the purpose of determining the genetic basis of their disease determined through this process.
Timepoint [2] 330619 0
2024
Secondary outcome [1] 406982 0
Determine patterns of care for patients with inherited cardiomyopathies, including hospitalisation and emergency department presentations, through use of data linkage to medical records, to determine the burden of disease
Timepoint [1] 406982 0
Patterns of care will be assessed annually from 2024 until the end of the ethics approved study period.
Secondary outcome [2] 406983 0
Determine the frequency of comorbidities amongst non-familial hypertrophy cardiomyopathy (HCM) patients through collection of comprehensive data focusing on factors that influence left ventricular hypertrophy e.g. sleep apnoea, weight, hypertension. These data will be collected in the study's clinical and health status surveys, via the Charlson Comorbidity Index (5-minute survey recording the participant's health conditions via telephone with study coordinator), and a sleep apnoea monitor (ApneaLink, a clinical sleep apnoea screening tool) where any participant with a apnoea-hypopnea index (AHI) score >5 will receive a phone call with the study coordinator to complete the Stop-Bang questionnaire.
Timepoint [2] 406983 0
Comorbidities will be assessed yearly from enrolment until the close of the study
Secondary outcome [3] 406984 0
Evaluate how participants with inherited cardiomyopathies interact with the healthcare system, especially those from under-represented patient sub-groups, allowing a deeper appreciation of the real-world burden of inherited cardiomyopathies, via self-reporting participant surveys and data linkage to routinely collected medical data in NSW. There are 3 questionnaires used in the surveys, which were otherwise designed specifically for this study: the SF-12 (Short Form health survey), the DASS (Depression, Anxiety and Stress Scale) and the HLQ (Health Literacy Questionnaire).
Timepoint [3] 406984 0
Comorbidities will be assessed yearly from enrolment until the close of the study

Eligibility
Key inclusion criteria
(1) Diagnosis of inherited cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy, arrhythmogenic cardiomyopathy, left ventricular noncompaction, restrictive cardiomyopathy, undiagnosed but familial cardiomyopathy, genetically confirmed heritable
cardiomyopathy not already eligible, asymptomatic gene carrier)
(2) Resident in NSW at time of consent
(3) Aged 17 years and older
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21854 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 21855 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [3] 21856 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 36917 0
2050 - Camperdown
Recruitment postcode(s) [2] 36918 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 36919 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 310878 0
Government body
Name [1] 310878 0
National Health and Medical Research Council
Country [1] 310878 0
Australia
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
384 Victoria St, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 312152 0
None
Name [1] 312152 0
Address [1] 312152 0
Country [1] 312152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310438 0
Sydney Local Health District HREC (RPA Zone)
Ethics committee address [1] 310438 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 310438 0
Australia
Date submitted for ethics approval [1] 310438 0
Approval date [1] 310438 0
21/01/2021
Ethics approval number [1] 310438 0

Summary
Brief summary
The NSW Inherited Cardiomyopathy Cohort or NSW HEARTS is a cohort study that aims to recruit over 2,500 participants from NSW with inherited cardiomyopathies, and prospectively follow them over time . The overarching aim of this study is to create a large, well-characterised cohort of patients with inherited cardiomyopathies in NSW for cross-sectional and longitudinal analysis. This will serve as an invaluable resource for numerous other research projects, as well as an opportunity for future data collection waves, extending follow-up even further.

Data collected will include clinical information, cardiac investigations, blood sample, cardiac MRI and NSW Health linked data. All participant samples will undergo whole-genome sequencing (WGS), which will allow us to investigate the impact of genetic variants. The resulting dataset will enable us to perform analyses that have the potential to solve the genetic basis of diseases for many families and will be directly translated to improved variant classification criteria. Moreover, we can also seek to understand this new paradigm of non-familial disease and allow precision-based approaches to the care of families.

Trial website
www.nswhearts.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117670 0
A/Prof Jodie Ingles
Address 117670 0
The Centre of Population Genomics,
Garvan Institute of Medical Research,
384 Victoria St, Darlinghurst NSW 2010
Country 117670 0
Australia
Phone 117670 0
+61 02 9359 8049
Fax 117670 0
Email 117670 0
[email protected]
Contact person for public queries
Name 117671 0
Jodie Ingles
Address 117671 0
The Centre of Population Genomics,
Garvan Institute of Medical Research,
384 Victoria St, Darlinghurst NSW 2010
Country 117671 0
Australia
Phone 117671 0
+61 02 9359 8049
Fax 117671 0
Email 117671 0
[email protected]
Contact person for scientific queries
Name 117672 0
Jodie Ingles
Address 117672 0
The Centre of Population Genomics,
Garvan Institute of Medical Research,
384 Victoria St, Darlinghurst NSW 2010
Country 117672 0
Australia
Phone 117672 0
+61 02 9359 8049
Fax 117672 0
Email 117672 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy and confidentiality reasons.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.