ANZCTR - Registration

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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]

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

Condition category

Condition code

Cardiovascular

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

All cause morbidity as determined from medical health records

Timepoint [1]

Minimum 5 years and annually for the entirety of the registry

Primary outcome [2]

Mortality as determined from medical health records

Timepoint [2]

Minimum 5 years and annually for the entirety of the registry

Secondary outcome [1]

Treatment as determined from medical health records

Timepoint [1]

Minimum 5 years and annually for the entirety of the registry

Secondary outcome [2]

Hospital admissions as determined from medical health records

Timepoint [2]

Minimum 5 years and annually for the entirety of the registry

Secondary outcome [3]

Clinical worsening as determined from diagnostic tests in medical health records

Timepoint [3]

Minimum 5 years and annually for the entirety of the registry

Secondary outcome [4]

Co-morbidities as determined from medical health records

Timepoint [4]

Minimum 5 years and annually for the entirety of the registry

Secondary outcome [5]

Transition of medical care from paediatric to adult healthcare professionals as determined from medical health records

Timepoint [5]

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]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

The Royal Childrens Hospital - Parkville

Recruitment hospital [3]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [4]

The Prince Charles Hospital - Chermside

Recruitment hospital [5]

Lady Cilento Children's Hospital - South Brisbane

Recruitment hospital [6]

The Children's Hospital at Westmead - Westmead

Recruitment hospital [7]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [8]

Womens and Childrens Hospital - North Adelaide

Recruitment hospital [9]

Princess Margaret Hospital - Subiaco

Recruitment hospital [10]

Royal Perth Hospital - Perth

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

3052 - Parkville

Recruitment postcode(s) [3]

4032 - Chermside

Recruitment postcode(s) [4]

4101 - South Brisbane

Recruitment postcode(s) [5]

2145 - Westmead

Recruitment postcode(s) [6]

5000 - Adelaide

Recruitment postcode(s) [7]

5006 - North Adelaide

Recruitment postcode(s) [8]

6008 - Subiaco

Recruitment postcode(s) [9]

6000 - Perth

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

HeartKids Limited

Address [1]

301/39 Hume St, Crows Nest NSW 2065

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

Research Ethics and Governance Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/11/2017

Approval date [1]

01/02/2018

Ethics approval number [1]

Summary

Brief summary

With an increasing prevalence of people with CHD, combined with a lack of data to characterise the full spectrum of cases or long-term outcomes, there is a critical need to understand the burden of CHD in Australia and New Zealand.
The development of a Regional Registry can generate the knowledge needed to better understand the true diversity of outcomes and burden of the entire spectrum of CHD across the lifespan. This information has the potential to drive policy development for the optimal management of both paediatric and adult populations to achieve better health outcomes.
This Registry will aim to capture data on patients diagnosed with a congenital heart defect at any age and will be conducted in congenital heart units throughout Australia and New Zealand. It will collect data from medical records on epidemiology, CHD history, clinical course, symptoms and burden of disease from all participants who were born with a CHD.
By participating in the Registry, hospitals will be able to provide patients with CHD an opportunity to contribute to the body of knowledge about the burden of CHD. This Regional CHD Registry will become a mandatory tool to provide best care to a growing population.

Trial website

www.chaanz.org.au

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof David Celermajer

Address

Cardiology Department
Missenden Road
Royal Prince Alfred Hospital
Camperdown, NSW 2050

Country

Australia

Phone

+61 2 9515 6111

Fax

Email

David.Celermajer@sswahs.nsw.gov.au

Contact person for public queries

Name

Geoff Strange

Address

Cardiology Department
Missenden Road
Royal Prince Alfred Hospital
Camperdown, NSW 2050

Country

Australia

Phone

+ 61 422 308 585

Fax

Email

geoff@mozaicsolutions.com.au

Contact person for scientific queries

Name

Geoff Strange

Address

Cardiology Department
Royal Prince Alfred Hospital
Missenden Road
Camperdown, NSW 2050

Country

Australia

Phone

+ 61 422 308 585

Fax

Email

geoff@mozaicsolutions.com.au

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.