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Trial registered on ANZCTR


Registration number
ACTRN12620000981921
Ethics application status
Approved
Date submitted
10/07/2020
Date registered
30/09/2020
Date last updated
30/09/2020
Date data sharing statement initially provided
30/09/2020
Date results provided
30/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The End Rheumatic Heart Disease in Australia Study of Epidemiology (ERASE) Project
Scientific title
Burden of rheumatic heart disease (RHD) and impact of prevention strategies: comprehensive evidence to drive the RHD Endgame
Secondary ID [1] 301628 0
NHMRC Grant ID: APP1146525

Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rheumatic heart disease 318025 0
Acute Rheumatic Fever 318026 0
Condition category
Condition code
Cardiovascular 316055 316055 0 0
Other cardiovascular diseases
Infection 316893 316893 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Using linked administrative data from five Australian jurisdictions (WA, SA, NT, NSW, QLD) from 2001 to 2018, this observational study seeks to: 1. Establish the burden and distribution of Acute Rheumatic Fever (ARF) and Rheumatic Heart Disease (RHD) 2. Undertake a series of historical cohort studies to determine progression and long-term outcomes of people with ARF and RHD.

This is a large project using a data base of historical ARF/RHD patients, who will be part of multiple cohort studies including:
1. All surgical patients receiving valve interventions 2002-2017
2. Patients with ARF episodes in particular time period (2002-2017)
3. Patients with RHD in particular time period (2002-2017)
4. Women with ARF or RHD concurrent with a pregnancy (2002- 2017)

Exposures include geography/remoteness, age, sex, and where appropriate surgery and secondary prophylaxis. Ethnicity (Indigenous / Non-Indigenous) will be considered in most sub-studies.

Participants will have no involvement in this study aside from their administrative data collected.

Note: This project consists of a series of sub-studies
Intervention code [1] 317929 0
Not applicable
Comparator / control treatment
There will be various sub-studies with different comparators. For example:
1. Comparison of outcomes with ARF only versus those with RHD (reference comparator is ARF)
2. Comparison of Indigenous / Non-Indigenous (reference comparator is Non-Indigenous)
3. Comparison by different levels of remoteness (reference comparator is metropolitan)
4. Comparison by surgery type or receipt of medication (For surgery the reference comparator is mechanical valves; For receipt of medication the reference comparator is 80% adherence (versus <80%)
5. Comparison of RHD registrants versus hospital only (reference comparator is RHD registrants)
Control group
Historical

Outcomes
Primary outcome [1] 324256 0
ARF/RHD incidence as measured by first-time record in linked data set.
Timepoint [1] 324256 0
Time to event for a maximum of 10 years
Primary outcome [2] 324639 0
RHD prevalence as measured by identification in any record and alive at a particular point in time. RHD prevalence will be assessed through the analysis of linked administrative data.
Timepoint [2] 324639 0
Time to event for a maximum of 10 years
Primary outcome [3] 324640 0
Progression from ARF to RHD and from RHD to cardiovascular RHD complications (heart failure, stroke, infective endocarditis and atrial fibrillation). Progression will be assessed through the analysis of linked administrative data.
Timepoint [3] 324640 0
Time to event for a maximum of 10 years
Secondary outcome [1] 384436 0
Pregnancy related complications. These will be assessed through the analysis of linked administrative data.
Timepoint [1] 384436 0
Time to event for a maximum of 10 years
Secondary outcome [2] 385303 0
Surgery related complications. These will be assessed through the analysis of linked administrative data.
Timepoint [2] 385303 0
Time to event for a maximum of 10 years
Secondary outcome [3] 385304 0
RHD associated mortality. This will be assessed through the analysis of linked administrative data.
Timepoint [3] 385304 0
Time to event for a maximum of 10 years
Secondary outcome [4] 385305 0
Costs associated with ARF/RHD. These will be assessed through the analysis of linked administrative data.
Timepoint [4] 385305 0
Time to event for a maximum of 10 years
Secondary outcome [5] 386494 0
All-cause mortality (in a cohort of prevalent RHD cases). This will be assessed through the analysis of linked administrative data.
Timepoint [5] 386494 0
Time to event for a maximum of 10 years

Eligibility
Key inclusion criteria
The cohort is any person, living or deceased, with a likely diagnosis of rheumatic fever or rheumatic heart disease, as identified by:

1. A record on an Australian ARF/RHD register (has been “registered”) or

2. At least one hospital admission (including all public and most private hospitals) with an ICD-10-
AM (Australian Modification) code of I00 to I02 (ARF) or I05 to I09 (RHD) in any diagnosis field or

3. A death registry record coded as I00 to I02 (ARF) or I05 to I09 (RHD) or an equivalent free text field (for later periods where the cause of death coding was not available) in any cause of death field.
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals in the linked data set not deemed to have RHD or ARF as defined by the ERASE protocol. This definition has taken into account short comings in ICD coding for RHD. (Please see study protocol attached to this application)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Analyses will be conducted using SAS, STATA, R and excel software, and will include:
• ARF incidence rates (by age group, remoteness and Aboriginal status), age-standardised using the direct method and the standard population in five-year periods to allow for small number of events.
• Trends based on hospital data, using Poisson regression with calendar period as one of the covariates.
• Age-specific RHD prevalence
• Rate of ARF recurrence (number of recurrences per 100 person-years). Proportional hazards regression will be used to investigate determinants of recurrence, with age at diagnosis, sex, Aboriginal status, residential remoteness, year at diagnosis, selected comorbidities, and hospital type as covariates.
• Spatial analysis of baseline burden measures
• Rate of progression from ARF to RHD for different time periods, using multivariate proportional hazards regression analysis. An additional analysis will be conducted on register cases (from 2009 onwards) that will include selected clinical variables, for example, presence of chorea at first diagnosis.
• Rate of progression from RHD to heart failure, using proportional hazards regression analysis of incidence of heart failure in people diagnosed with RHD.
• Hospital-related costs
• Sensitivity analyses to evaluate the effect of using different definitional algorithms of ARF and RHD cases on incidence of ARF (capture-recapture methods).
• Rate of RHD-related birth admissions, morbidity and mortality rates, as well as cardiac, maternal and perinatal outcomes associated with RHD during pregnancy (RHD-P) and between pregnancies for women.
• Descriptive demographic and clinical profiles of pregnant women with RHD and RF, including Indigenous status, jurisdiction, accessibility/remoteness index of Australia, RHD register status, age at first RF/RHD diagnosis, disease type (RF/RHD) and severity of disease, history of diagnosis, pathway during (and between) pregnancies; parity; interventions (cardiac investigations and other interventions before and during pregnancy and the peripartum up to one year postpartum). Maternal and perinatal outcomes will be compared by parity and RHD status.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
Actual
31/12/2018
Date of last data collection
Anticipated
Actual
31/12/2018
Sample size
Target
15000
Accrual to date
Final
42064
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 306061 0
Government body
Name [1] 306061 0
National Health and Medical Research Council
Country [1] 306061 0
Australia
Funding source category [2] 306146 0
Charities/Societies/Foundations
Name [2] 306146 0
HeartKids
Country [2] 306146 0
Australia
Primary sponsor type
Individual
Name
Dr Judith Katzenellenbogen
Address
School of Population and Global Health
The University of Western Australia
M431, 35 Stirling Highway
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 306522 0
University
Name [1] 306522 0
The University of Western Australia
Address [1] 306522 0
The University of Western Australia
35 Stirling Highway
Perth WA 6009
Australia
Country [1] 306522 0
Australia
Secondary sponsor category [2] 306616 0
Charities/Societies/Foundations
Name [2] 306616 0
Telethon Kids Institute
Address [2] 306616 0
Telethon Kids Institute
Northern Entrance
Perth Children's Hospital
15 Hospital Avenue
NEDLANDS WA 6009
Country [2] 306616 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306284 0
Department of Health WA Human Research Ethics Committee
Ethics committee address [1] 306284 0
Ethics committee country [1] 306284 0
Australia
Date submitted for ethics approval [1] 306284 0
17/05/2016
Approval date [1] 306284 0
13/06/2016
Ethics approval number [1] 306284 0
2016/29
Ethics committee name [2] 306326 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [2] 306326 0
Ethics committee country [2] 306326 0
Australia
Date submitted for ethics approval [2] 306326 0
11/05/2016
Approval date [2] 306326 0
13/10/2016
Ethics approval number [2] 306326 0
717
Ethics committee name [3] 306327 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [3] 306327 0
Ethics committee country [3] 306327 0
Australia
Date submitted for ethics approval [3] 306327 0
07/11/2016
Approval date [3] 306327 0
21/12/2016
Ethics approval number [3] 306327 0
2016-2705
Ethics committee name [4] 306328 0
SA Department for Health and Wellbeing Human Research Ethics Committee
Ethics committee address [4] 306328 0
Ethics committee country [4] 306328 0
Australia
Date submitted for ethics approval [4] 306328 0
15/11/2016
Approval date [4] 306328 0
13/12/2016
Ethics approval number [4] 306328 0
HREC/16/SAH/120
Ethics committee name [5] 306361 0
SA Aboriginal Health Research Ethics Committee
Ethics committee address [5] 306361 0
Ethics committee country [5] 306361 0
Australia
Date submitted for ethics approval [5] 306361 0
14/11/2016
Approval date [5] 306361 0
07/12/2016
Ethics approval number [5] 306361 0
04-16-700
Ethics committee name [6] 306362 0
Queensland Public Health Act
Ethics committee address [6] 306362 0
Ethics committee country [6] 306362 0
Australia
Date submitted for ethics approval [6] 306362 0
01/02/2018
Approval date [6] 306362 0
10/04/2018
Ethics approval number [6] 306362 0
HREC/15/QPCH/289
Ethics committee name [7] 306363 0
Queensland Human Research Ethics Committee
Ethics committee address [7] 306363 0
Ethics committee country [7] 306363 0
Australia
Date submitted for ethics approval [7] 306363 0
26/11/2015
Approval date [7] 306363 0
02/12/2015
Ethics approval number [7] 306363 0
HREC/15/QPCH/289
Ethics committee name [8] 306386 0
Aboriginal Health and Medical Research Council (AH&MRC) of NSW
Ethics committee address [8] 306386 0
Ethics committee country [8] 306386 0
Australia
Date submitted for ethics approval [8] 306386 0
17/01/2018
Approval date [8] 306386 0
05/03/2018
Ethics approval number [8] 306386 0
1363/18
Ethics committee name [9] 306387 0
NSW Population & Health Services Research Ethics Committee
Ethics committee address [9] 306387 0
Ethics committee country [9] 306387 0
Australia
Date submitted for ethics approval [9] 306387 0
24/01/2018
Approval date [9] 306387 0
22/05/2018
Ethics approval number [9] 306387 0
2018/HRE0401

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103366 0
Dr Judith Katzenellenbogen
Address 103366 0
School of Population and Global Health
The University of Western Australia
M431, 35 Stirling Highway
Crawley WA
6009
Country 103366 0
Australia
Phone 103366 0
+61 8 6488 1001
Fax 103366 0
Email 103366 0
judith.katzenellenbogen@uwa.edu.au
Contact person for public queries
Name 103367 0
Judith Katzenellenbogen
Address 103367 0
School of Population and Global Health
The University of Western Australia
M431, 35 Stirling Highway
Crawley WA
6009
Country 103367 0
Australia
Phone 103367 0
+61 8 6488 1001
Fax 103367 0
Email 103367 0
judith.katzenellenbogen@uwa.edu.au
Contact person for scientific queries
Name 103368 0
Judith Katzenellenbogen
Address 103368 0
School of Population and Global Health
The University of Western Australia
M431, 35 Stirling Highway
Crawley WA
6009
Country 103368 0
Australia
Phone 103368 0
+61 8 6488 1001
Fax 103368 0
Email 103368 0
judith.katzenellenbogen@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study involves analysis of de-identified routinely collected administrative data and does not involve any contact with participants. Whenever results are reported for the project, only aggregate data will be presented and if the cell size within a group for any given outcome is less than 5, individual numbers will not be displayed. This is in accordance with ethical requirements for this data. Data dictionaries and statistical code are available on request.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8411Study protocolKatzenellenbogen JM, Bond-Smith D, Seth RJ, Dempsey K, Cannon J, Nedkoff L, Sanfilippo FM, de Klerk N, Hung J, Geelhoed E, Williamson D. The End Rheumatic Heart Disease in Australia Study of Epidemiology (ERASE) Project: data sources, case ascertainment and cohort profile. Clinical Epidemiology. 2019;11:997.https://www.dovepress.com/getfile.php?fileID=54027 
8413Ethical approvalAboriginal Health and Medical Research Council (AH&MRC) of NSW   380077-(Uploaded-10-07-2020-01-43-39)-Study-related document.pdf
8452Ethical approvalSA Aboriginal Health Research Ethics Committee    380077-(Uploaded-10-07-2020-01-44-55)-Study-related document.pdf
8453Ethical approvalNSW Population & Health Services Research Ethics Committee   380077-(Uploaded-10-07-2020-01-45-56)-Study-related document.pdf
8454Ethical approvalQueensland Human Research Ethics Committee   380077-(Uploaded-10-07-2020-01-46-49)-Study-related document.pdf
8455Ethical approvalQueensland Public Health Act   380077-(Uploaded-10-07-2020-01-48-05)-Study-related document.pdf
8456Ethical approvalSA Department for Health and Wellbeing Human Research Ethics Committee   380077-(Uploaded-10-07-2020-01-49-04)-Study-related document.pdf
8457Ethical approvalHuman Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research   380077-(Uploaded-10-07-2020-01-50-11)-Study-related document.pdf
8458Ethical approvalDepartment of Health WA Human Research Ethics Committee   380077-(Uploaded-10-07-2020-01-50-50)-Study-related document.pdf
8459Ethical approvalWestern Australian Aboriginal Health Ethics Committee    380077-(Uploaded-10-07-2020-01-51-39)-Study-related document.pdf
8707Statistical analysis plan    Available on request only when complete
8708Analytic code    Available on request only when complete



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEarly Release - Excess Deaths Associated with Rheumatic Heart Disease, Australia, 2013–2017 - Volume 30, Number 1—January 2024 - Emerging Infectious Diseases journal - CDC2024https://doi.org/10.3201/eid3001.230905
N.B. These documents automatically identified may not have been verified by the study sponsor.