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Trial registered on ANZCTR


Registration number
ACTRN12620000494932
Ethics application status
Approved
Date submitted
6/03/2020
Date registered
20/04/2020
Date last updated
20/04/2020
Date data sharing statement initially provided
20/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australian and New Zealand Pulmonary Hypertension Patient Registry
Scientific title
Australian and New Zealand Pulmonary Hypertension Patient Registry
Secondary ID [1] 300677 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 316477 0
Condition category
Condition code
Respiratory 314722 314722 0 0
Other respiratory disorders / diseases
Cardiovascular 314723 314723 0 0
Other cardiovascular diseases
Inflammatory and Immune System 314724 314724 0 0
Connective tissue diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
15
Target follow-up type
Years
Description of intervention(s) / exposure
The registry will collect only secondary sourced data that is collected as part of routine clinical care in accordance with internationally published guidelines. As part of routine clinical care, all patients are expected to undergo a echocardiogram, six-minute walk test and if clinically indicated a right heart catheter on a six monthly basis in order to qualify for medication supplied by the Pharmaceutical Benefits Scheme as part of the Specialised Drugs Programme.

Data points that are attached to the registry include, mandatory evaluations specific to ongoing PBS medication approval and other diagnostic interventions necessary for the diagnosis and ongoing management of pulmonary hypertension.

Registry data points:
- Right Heart Catheterisation
- Echocardiogram
- 6 Minute Walk Test
-Pulmonary Function Tests
- Medications
- Social History i.e. use of alcohol, tobacco, illicit drugs
- Hospitalisations
- CT chest scan
-Ventilation/perfusion scan
-Pulmonary Angiogram
Intervention code [1] 317003 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323073 0
The primary objective of the Australian and New Zealand Pulmonary Hypertension Patient Registry is to capture all prevalent and incident data on adult and paediatric patients with PH particularly PAH and CTEPH subgroups
Data collected will be secondary data sourced from medical records and hospital databases as a result of routine clinical care e.g. right heart catheter, six-minute walk test, echocardiogram, pulmonary function tests. Data will also be collected as result of face to face consultation, e.g details regarding medications, social history and hospitalisations.



Timepoint [1] 323073 0
Participants are reviewed every six months from enrolment, until the registry is has reached its end point as decided by the Australian and New Zealand Pulmonary Hypertension Society
Secondary outcome [1] 381781 0
The secondary purpose of the PH registry is to formally characterise this patient population.
Timepoint [1] 381781 0
The study aims to document the history of PH in addition to the current diagnostic and treatment trends in Australia and New Zealand.
Data sourced from medical records and regular routine clinical visits will provide an opportunity to collate patient focused outcomes.

Eligibility
Key inclusion criteria
Patients will be eligible for entry into the registry if they meet the following criteria for Pulmonary Hypertension:
1. A current diagnosis of pulmonary hypertension and right heart catheter and echocardiogram performed at baseline demonstrating pulmonary hypertension (mPAP >20 mmg Hg
2. Exceptionally, patients may be enrolled with pulmonary hypertension diagnosed on ECHO, without invasive measurements, for example paediatric patients. Adult cases without invasive measurements will be discussed with the medical director of the Registry.
3. Prevalent cases may be enrolled retrospectively. Incident and prevalent cases will have ongoing prospective secondary sourced data collected on aspects of demographics, survival status and points relating to routine clinical care. No additional data will be collected that is not part of routine clinical care. Any missing data that is not collected as part of routine clinical practice will be left blank and coded as “not available”.
The Registry will enrol patients aged 3 months and older at designated Paediatric centres where approval has been sought from Paediatric HREC.
The Registry will enrol patients age 18 years or older at adult centres, and also mature minors at those sites in Australia and New Zealand where HREC approval is granted.
Participants aged 16 years and over are eligible for enrolment in Adult centres in New Zealand


Minimum age
3 Months
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All patients with a confirmed diagnosis of pulmonary hypertension are eligible to be enrolled in the PHSANZ Patient registry.
Patients who are excluded from the registry will be those patients whose definitive diagnosis excludes them from having pulmonary hypertension

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
All patients presenting for treatment at centres of excellence are eligible for enrolment.
The registry will collect only secondary sourced data that is collected as part of routine clinical care in accordance with internationally published guidelines.
The registry is a centralised database with multi-tenant access developed using FileMaker Pro 16 software. Specialist centres will access via FileMaker Pro being installed on their hospital computer.
All data will be pooled in a non- identifiable fashion for analysis and registry projects. Local PH physicians will have access to analysis tools for means of data points on their own individual pooled patients.
Data will be reported in non-identifiable averages and presented for publication in scientific peer reviewed journals.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 16009 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 16010 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 16011 0
St George Hospital - Kogarah
Recruitment hospital [4] 16012 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 16013 0
Nepean Hospital - Kingswood
Recruitment hospital [6] 16014 0
John Hunter Hospital - New Lambton
Recruitment hospital [7] 16015 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [8] 16016 0
The Alfred - Melbourne
Recruitment hospital [9] 16017 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 16018 0
Royal Hobart Hospital - Hobart
Recruitment hospital [11] 16019 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [12] 16021 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [13] 16022 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [14] 16023 0
The Prince Charles Hospital - Chermside
Recruitment hospital [15] 16024 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [16] 16025 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [17] 16026 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [18] 16027 0
Perth Children's Hospital - Nedlands
Recruitment hospital [19] 16028 0
The Wesley Hospital - Auchenflower
Recruitment hospital [20] 16029 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [21] 16030 0
Gold Coast Hospital - Southport
Recruitment hospital [22] 16391 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment postcode(s) [1] 29520 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 29521 0
2170 - Liverpool
Recruitment postcode(s) [3] 29522 0
2217 - Kogarah
Recruitment postcode(s) [4] 29523 0
2050 - Camperdown
Recruitment postcode(s) [5] 29524 0
2747 - Kingswood
Recruitment postcode(s) [6] 29525 0
2305 - New Lambton
Recruitment postcode(s) [7] 29526 0
2109 - Macquarie Park
Recruitment postcode(s) [8] 29527 0
3004 - Melbourne
Recruitment postcode(s) [9] 29528 0
5000 - Adelaide
Recruitment postcode(s) [10] 29529 0
7000 - Hobart
Recruitment postcode(s) [11] 29530 0
6150 - Murdoch
Recruitment postcode(s) [12] 29532 0
3052 - Parkville
Recruitment postcode(s) [13] 29533 0
3084 - Heidelberg
Recruitment postcode(s) [14] 29534 0
4032 - Chermside
Recruitment postcode(s) [15] 29535 0
4102 - Woolloongabba
Recruitment postcode(s) [16] 29536 0
4029 - Herston
Recruitment postcode(s) [17] 29537 0
4101 - South Brisbane
Recruitment postcode(s) [18] 29538 0
6009 - Nedlands
Recruitment postcode(s) [19] 29539 0
4066 - Auchenflower
Recruitment postcode(s) [20] 29540 0
4215 - Southport
Recruitment postcode(s) [21] 29935 0
4575 - Birtinya
Recruitment outside Australia
Country [1] 22401 0
New Zealand
State/province [1] 22401 0
Auckland
Country [2] 22402 0
New Zealand
State/province [2] 22402 0
Christchurch

Funding & Sponsors
Funding source category [1] 305117 0
Commercial sector/Industry
Name [1] 305117 0
GSK
Address [1] 305117 0
GSK Melbourne, Pharmaceutical company
3/436 Johnston St, Abbotsford VIC 3067

Country [1] 305117 0
Australia
Funding source category [2] 305186 0
Commercial sector/Industry
Name [2] 305186 0
Actelion
Address [2] 305186 0
Actelion, a business unit of Janssen Australia and New Zealand (Janssen-Cilag Pty Ltd)
66 Waterloo Rd, Macquarie Park NSW 2113



Country [2] 305186 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australian and New Zealand Pulmonary Hypertension Society Inc
Address
CEO, Professor Geoff Strange, PO Box 133, Sans Souci, NSW 2219
Country
Australia
Secondary sponsor category [1] 305543 0
None
Name [1] 305543 0
Address [1] 305543 0
Country [1] 305543 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305491 0
St Vincent's Hospital, Sydney
Ethics committee address [1] 305491 0
St Vincent’s Hospital Translational Research Centre
97-105 Boundary Street
Darlinghurst NSW 2010
Tel: 02 8382 4960
E-mail: SVHS.Research@svha.org.au
Ethics committee country [1] 305491 0
Australia
Date submitted for ethics approval [1] 305491 0
28/10/2011
Approval date [1] 305491 0
07/11/2011
Ethics approval number [1] 305491 0
LNR/11/SVH/178

Summary
Brief summary
The primary objective of the Australian and New Zealand Pulmonary Hypertension Patient Registry is to capture all prevalent and incident data on adult and paediatric patients with PH particularly PAH and CTEPH subgroups, presenting to centres of excellence to assist in future service planning, resource allocation and to promote equitable and timely access to life saving therapies and to audit standards of care across Australia and New Zealand.

The secondary purpose of the PH registry is to formally characterise this patient population. The study aims to document the history of PH in addition to the current diagnostic and treatment trends in Australia and New Zealand

Further, Australian data has previously shown a significant delay in the time to diagnosis.
The ANZ Pulmonary Hypertension Patient Registry may serve as a tool to advocate for standardisation in access to skilled clinical care. Importantly it will allow pulmonary
hypertension centres in Australia to compare their performance with national (aggregated) benchmarks.
Trial website
https://phsanz.nicheit.com.au/fmi/webd/PHSANZ%20Registry.fmp12
Trial related presentations / publications
Public notes
Time from symptoms to definitive diagnosis of idiopathic pulmonary arterial hypertension: The delay study
Geoff Strange1, Eli Gabbay2, Fiona Kermeen3, Trevor Williams4, Melinda Carrington5, Simon Stewart5, and Anne Keogh6
Pulmonary Circulation | January-March 2013 | Vol 3 | No 1

Contacts
Principal investigator
Name 100546 0
A/Prof Eugene Kotlyar
Address 100546 0
Heart and Lung Transplant Unit
Level 4, Xavier Building
St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Country 100546 0
Australia
Phone 100546 0
+61 422 308 585
Fax 100546 0
Email 100546 0
geoff@phsanz.org
Contact person for public queries
Name 100547 0
Prof Geoffrey Strange
Address 100547 0
Pulmonary Hypertension Society of Australia and New Zealand
PO Box 133,
Sans Souci,
NSW 2219
Country 100547 0
Australia
Phone 100547 0
+61 422 308 585
Fax 100547 0
Email 100547 0
geoff@phsanz.org
Contact person for scientific queries
Name 100548 0
Prof Geoffrey Strange
Address 100548 0
Pulmonary Hypertension Society of Australia and New Zealand
PO Box 133,
Sans Souci,
NSW 2219
Country 100548 0
Australia
Phone 100548 0
+61 422 308 585
Fax 100548 0
Email 100548 0
geoff@phsanz.org

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 reported in non-identifiable pooled averages for analysis and registry project.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7273 0
Study protocol
Citation [1] 7273 0
Link [1] 7273 0
Email [1] 7273 0
Other [1] 7273 0
Type [2] 7274 0
Ethical approval
Citation [2] 7274 0
Link [2] 7274 0
Email [2] 7274 0
Other [2] 7274 0
HREC St Vincent's Hospital, Sydney is lead site for 13 registry sites under the NMA scheme.
Other HREC's are The Alfred, (Vic), Royal Hobart Hospital, Royal Perth Hospital - for Fiona Stanley Hospital, Auckland City Hospital (New Zealand)
HREC Royal Children's Hospital (Vic) is lead HREC for 5 registry sites under the NMA scheme.
Other Paediatric HREC is Royal Perth, Starship (New Zealand)
Type [3] 7275 0
Informed consent form
Citation [3] 7275 0
Link [3] 7275 0
Email [3] 7275 0
Other [3] 7275 0
Type [4] 7276 0
Ethical approval
Citation [4] 7276 0
Link [4] 7276 0
Email [4] 7276 0
Other [4] 7276 0
Ethics approval Royal Children's Hospital
Type [5] 7277 0
Ethical approval
Citation [5] 7277 0
Link [5] 7277 0
Email [5] 7277 0
Other [5] 7277 0
HREC St Vincent's Hospital, Sydney, HREC extension approval
Type [6] 7280 0
Informed consent form
Citation [6] 7280 0
Link [6] 7280 0
Email [6] 7280 0
Other [6] 7280 0
Mature Minor Patient Information and Consent Form
Type [7] 7282 0
Informed consent form
Citation [7] 7282 0
Link [7] 7282 0
Email [7] 7282 0
Other [7] 7282 0
Paediatric Patient Information and Consent Form
Summary results
No Results