Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001531202
Ethics application status
Approved
Date submitted
27/07/2018
Date registered
13/09/2018
Date last updated
12/04/2019
Date data sharing statement initially provided
12/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Congenital Heart Alliance of Australia and New Zealand (CHAANZ) Congenital Heart Disease Registry
Scientific title
Congenital Heart Alliance of Australia and New Zealand (CHAANZ) Congenital Heart Disease Registry
Secondary ID [1] 295669 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
CHAANZ CHD Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Heart Disease 309025 0
Condition category
Condition code
Cardiovascular 307922 307922 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
15
Target follow-up type
Years
Description of intervention(s) / exposure
There is no intervention. Congenital Heart Disease (CHD) incorporates a group of abnormalities of the heart at birth. Such abnormalities range from relatively simple defects to more complex conditions that incorporate multiple and major defects involving both the heart and the blood vessels connected to it. Retrospective data will be collected on all participants at the start of the study and then periodically for follow-up visits according to routine standard of care. There are no required clinical procedures; the treating clinician will determine the assessments, laboratory tests, imaging procedures, and other evaluations to be performed for each participant as part of routine clinical care. All necessary information will be gathered from patient medical records as secondary source data retrospectively and then prospectively during ongoing patient follow-up in the Registry. Participants will remain active in the registry until they withdraw, become lost to follow up or deceased.
Intervention code [1] 301986 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306888 0
All cause morbidity as determined from medical health records
Timepoint [1] 306888 0
Minimum 5 years and annually for the entirety of the registry
Primary outcome [2] 306889 0
Mortality as determined from medical health records
Timepoint [2] 306889 0
Minimum 5 years and annually for the entirety of the registry
Secondary outcome [1] 350034 0
Treatment as determined from medical health records
Timepoint [1] 350034 0
Minimum 5 years and annually for the entirety of the registry
Secondary outcome [2] 350035 0
Hospital admissions as determined from medical health records
Timepoint [2] 350035 0
Minimum 5 years and annually for the entirety of the registry
Secondary outcome [3] 350036 0
Clinical worsening as determined from diagnostic tests in medical health records
Timepoint [3] 350036 0
Minimum 5 years and annually for the entirety of the registry
Secondary outcome [4] 350037 0
Co-morbidities as determined from medical health records
Timepoint [4] 350037 0
Minimum 5 years and annually for the entirety of the registry
Secondary outcome [5] 350038 0
Transition of medical care from paediatric to adult healthcare professionals as determined from medical health records
Timepoint [5] 350038 0
Minimum 5 years and annually for the entirety of the registry

Eligibility
Key inclusion criteria
1. Participants of any age, including children, infants and neonates.
2. Participant or parent (or legal guardian) is able to understand the consent and must be willing and able to give consent or assent (if applicable as determined by the Independent Ethics Committees) via the opt-out consent process.
3. Diagnosis of Congenital Heart Disease.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Expressed wish not to participate.
2. Participant or patient’s parent/legal guardian unable to give consent.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
There is no defined sample size for this registry as its aim is to capture CHD incidence. Data may be readily exported for use with Excel, SPSS, SAS, R and other third party software. All data will be pooled for analysis in a de-identifiable manner. Local physicians will have access to analysis tools for means of data points on their own individual pooled patients. Only
pooled de-identified averages will be reported for this registry.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
11/03/2019
Date of last participant enrolment
Anticipated
1/09/2033
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60000
Accrual to date
4300
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 11512 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 11513 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [3] 11514 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 11515 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 11516 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [6] 11518 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [7] 11519 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 11520 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [9] 11523 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [10] 11524 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 23537 0
2050 - Camperdown
Recruitment postcode(s) [2] 23538 0
3052 - Parkville
Recruitment postcode(s) [3] 23539 0
4032 - Chermside
Recruitment postcode(s) [4] 23540 0
4101 - South Brisbane
Recruitment postcode(s) [5] 23541 0
2145 - Westmead
Recruitment postcode(s) [6] 23542 0
5000 - Adelaide
Recruitment postcode(s) [7] 23543 0
5006 - North Adelaide
Recruitment postcode(s) [8] 23546 0
6008 - Subiaco
Recruitment postcode(s) [9] 23547 0
6000 - Perth
Recruitment outside Australia
Country [1] 10682 0
New Zealand
State/province [1] 10682 0
Auckland

Funding & Sponsors
Funding source category [1] 300250 0
Charities/Societies/Foundations
Name [1] 300250 0
HeartKids Limited
Country [1] 300250 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Congenital Heart Disease Alliance of Australia and New Zealand (CHAANZ)
Address
CHAANZ is a subcommittee of HeartKids Ltd, 301/39 Hume St, Crows Nest NSW 2065
Country
Australia
Secondary sponsor category [1] 299672 0
None
Name [1] 299672 0
Address [1] 299672 0
Country [1] 299672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301072 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 301072 0
Ethics committee country [1] 301072 0
Australia
Date submitted for ethics approval [1] 301072 0
28/11/2017
Approval date [1] 301072 0
01/02/2018
Ethics approval number [1] 301072 0

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

Contacts
Principal investigator
Name 85786 0
Prof David Celermajer
Address 85786 0
Cardiology Department
Missenden Road
Royal Prince Alfred Hospital
Camperdown, NSW 2050
Country 85786 0
Australia
Phone 85786 0
+61 2 9515 6111
Fax 85786 0
Email 85786 0
[email protected]
Contact person for public queries
Name 85787 0
Geoff Strange
Address 85787 0
Cardiology Department
Missenden Road
Royal Prince Alfred Hospital
Camperdown, NSW 2050
Country 85787 0
Australia
Phone 85787 0
+ 61 422 308 585
Fax 85787 0
Email 85787 0
[email protected]
Contact person for scientific queries
Name 85788 0
Geoff Strange
Address 85788 0
Cardiology Department
Royal Prince Alfred Hospital
Missenden Road
Camperdown, NSW 2050
Country 85788 0
Australia
Phone 85788 0
+ 61 422 308 585
Fax 85788 0
Email 85788 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
All data will be pooled for analysis in a de-identifiable manner and only summarised data will be reported.


What supporting documents are/will be available?

No Supporting Document Provided



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.