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Trial registered on ANZCTR


Registration number
ACTRN12617001387314
Ethics application status
Approved
Date submitted
4/09/2017
Date registered
29/09/2017
Date last updated
3/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
National Echocardiography Database Australia (NEDA). A longitudinal cohort study of echocardiograms from public and private echocardiography laboratories from around Australia, linked with the National Deaths Index.
Scientific title
National Echocardiography Database Australia (NEDA). A multicentre cohort longitudinal echocardiography study involving public and private echocardiography laboratories around Australia, assessing the prevalence and mortality of pulmonary hypertension and other cardiac abnormalities identified by echocardiography.
Secondary ID [1] 292734 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
NEDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 304501 0
Pulmonary Hypertension 304502 0
Condition category
Condition code
Cardiovascular 303838 303838 0 0
Other cardiovascular diseases
Cardiovascular 303839 303839 0 0
Normal development and function of the cardiovascular system
Respiratory 304138 304138 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention. Measurements and text interpretation information performed as part of a standard echo examination are collected from a backup copy of the echo database at each lab. The duration of the observation is from the first echo ever entered into the clinical database at the lab until the last echo entered when the backup database was taken. This time interval varies among each laboratory in Australia, and is dependent on when digital echocardiography was installed in the laboratory, and may be as long as 10 years. Since NEDA is a real world database, there is no intervention and no change to practice with NEDA.
Intervention code [1] 298978 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303199 0
Prevalence of pulmonary hypertension, defined by elevated pulmonary artery systolic pressure (PASP) >40mmHg measured by echocardiography, in a diverse Australian population.
Timepoint [1] 303199 0
The true prevalence in our echo cohort will be the proportion of patients with pulmonary hypertension in NEDA. The minimum indicative prevalence of pulmonary hypertension will be measured by the prevalence of pulmonary hypertension in our cohort of echocardiography patients projected against the Australian population. The time period for the observation will be those having echocardiography within the last 2 years and still alive at the time of the data analysis.
Primary outcome [2] 303203 0
Prognosis of Pulmonary Hypertension as defined by Pulmonary Arterial Systolic Pressure (PASP) >= 40mmHg measured using echocardiography from within the NEDA cohort, matched against mortality, provided data linkage with the National Deaths Index.
Timepoint [2] 303203 0
The time period for the observation will be those having echocardiography within the last 2 years and still alive at the time of the data analysis.
Secondary outcome [1] 338231 0
The association between pulmonary artery systolic pressure and echo variables: left ventricular ejection fraction, mitral inflow E wave velocity, myocardial relaxation septal E’ velocity, E:E’ ratio, left atrial volume, right ventricular TAPSE, right ventricular basal and mid diameters, right ventricular Tei index, Noninvasive PVR estimation (Schiller equation), and right atrial volume.
Timepoint [1] 338231 0
Each echo variable will be analysed against pulmonary artery systolic pressure using standard statistical analysis tools. The time period for the observation will be all echocardiograms in the NEDA database.
Secondary outcome [2] 338232 0
Identification of additional echo parameters associated with markers of pulmonary hypertension disease severity and predictors of death. This is an exploratory analysis designed to identify those additional markers not identified as standard markers, and those not included in Secondary Outcome 1.
Timepoint [2] 338232 0
The time period for the observation will be all echocardiograms in the NEDA database.
Secondary outcome [3] 338233 0
Identification of reference ranges for echocardiographic variables. Reference intervals refer to the normal ranges normally found in healthy individuals. Since NEDA is a "big data" database, it is well suited to analysis of subgroups such as those without any demonstrable disease. Each individual measurement (up to 150 individual variables) will be subjected to this analysis. Only variables in which valid conclusions can be drawn based on the number of available measurements will be reported.
Timepoint [3] 338233 0
The time period for the observation will be all echocardiograms in the NEDA database.

Eligibility
Key inclusion criteria
Participants will be considered those who have undergone echocardiography at one of the participating centres in accordance with standard clinical practice.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals under the age of 18 will be excluded from the study and those who withdraw their consent. There are no other exclusion criteria for participants involved in the study. Individual data points may be excluded if a clause is present in an echo study suggesting that image quality was insufficient for accurate diagnostic imaging to be performed.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
The planned sample size of 900,000 is based on 150 Australian
laboratories reporting an average of 3000 studies per year, with at least
one year of retrospective data available. This sample size will provide
good precision to estimate the prevalence of pulmonary hypertension, and the associated abnormalities of echocardiographic variables. Based on our previous data of an estimated median survival of 4.3+/-0.1 years for patients with all-cause pulmonary hypertension, a sample size of 779 PHT patients would be required to identify a characteristic associated with a 10% increase in risk, with power 80%, alpha level 0.05.
Since NEDA will have a vastly greater sample size than the necessary sample size for risk prediction described above, NEDA will be well powered to address the primary and secondary outcomes.

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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 8873 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 8874 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 8875 0
Springwood Hospital - Springwood
Recruitment hospital [4] 8876 0
Blue Mountains District ANZAC Memorial Hospital - Katoomba
Recruitment hospital [5] 8877 0
Hawkesbury District Health Service - Windsor
Recruitment hospital [6] 8878 0
John Hunter Hospital - New Lambton
Recruitment hospital [7] 8879 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [8] 8880 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [9] 8881 0
Royal Hobart Hospital - Hobart
Recruitment hospital [10] 8882 0
Sunshine Hospital - St Albans
Recruitment hospital [11] 8883 0
Footscray Hospital - Footscray
Recruitment hospital [12] 8884 0
Royal Perth Hospital - Perth
Recruitment hospital [13] 8885 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [14] 8886 0
Belmont Hospital - Belmont
Recruitment hospital [15] 8887 0
The Maitland Hospital - Maitland
Recruitment hospital [16] 11765 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [17] 11766 0
The Prince Charles Hospital - Chermside
Recruitment hospital [18] 11767 0
Blacktown Hospital - Blacktown
Recruitment hospital [19] 11768 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment hospital [20] 11769 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 17123 0
2050 - Camperdown
Recruitment postcode(s) [2] 17124 0
2747 - Kingswood
Recruitment postcode(s) [3] 17125 0
2777 - Springwood
Recruitment postcode(s) [4] 17126 0
2780 - Katoomba
Recruitment postcode(s) [5] 17127 0
2756 - Windsor
Recruitment postcode(s) [6] 17128 0
2305 - New Lambton
Recruitment postcode(s) [7] 17129 0
2010 - Darlinghurst
Recruitment postcode(s) [8] 17130 0
0810 - Tiwi
Recruitment postcode(s) [9] 17131 0
7000 - Hobart
Recruitment postcode(s) [10] 17132 0
3021 - St Albans
Recruitment postcode(s) [11] 17133 0
3011 - Footscray
Recruitment postcode(s) [12] 17134 0
6000 - Perth
Recruitment postcode(s) [13] 17135 0
6150 - Murdoch
Recruitment postcode(s) [14] 17136 0
2280 - Belmont
Recruitment postcode(s) [15] 17137 0
2320 - Maitland
Recruitment postcode(s) [16] 23860 0
3220 - Geelong
Recruitment postcode(s) [17] 23861 0
4032 - Chermside
Recruitment postcode(s) [18] 23862 0
2148 - Blacktown
Recruitment postcode(s) [19] 23863 0
3004 - Melbourne
Recruitment postcode(s) [20] 23864 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 297371 0
Commercial sector/Industry
Name [1] 297371 0
Glaxo Smith-Kleine Pharmaceuticals
Address [1] 297371 0
1061 Mountain Highway, Boronia Victoria 3155
Country [1] 297371 0
Australia
Funding source category [2] 297376 0
Commercial sector/Industry
Name [2] 297376 0
Actelion Pharmaceuticals
Address [2] 297376 0
Ste 6/ 13B Narabang Way, Belrose New South Wales 2085
Country [2] 297376 0
Australia
Funding source category [3] 297377 0
Commercial sector/Industry
Name [3] 297377 0
Bayer Pharmaceuticals
Address [3] 297377 0
875 Pacific Highway, Pymble New South Wales 2073
Country [3] 297377 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
NEDA Limited
Address
Unit 41, Mount Medical Centre
146 Mounts Bay Road
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 296354 0
None
Name [1] 296354 0
Address [1] 296354 0
Country [1] 296354 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298475 0
University of Notre Dame
Ethics committee address [1] 298475 0
PO Box 1225
Fremantle, Western Australia 6959
Ethics committee country [1] 298475 0
Australia
Date submitted for ethics approval [1] 298475 0
18/08/2014
Approval date [1] 298475 0
13/10/2014
Ethics approval number [1] 298475 0
Ethics committee name [2] 298499 0
Sydney Local Health District HREC
Ethics committee address [2] 298499 0
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [2] 298499 0
Australia
Date submitted for ethics approval [2] 298499 0
27/10/2015
Approval date [2] 298499 0
16/03/2016
Ethics approval number [2] 298499 0
Ethics committee name [3] 298501 0
Australian Institute of Health and Welfare Ethics Committee
Ethics committee address [3] 298501 0
GPO Box 570
Canberra ACT 2601
Ethics committee country [3] 298501 0
Australia
Date submitted for ethics approval [3] 298501 0
31/01/2016
Approval date [3] 298501 0
03/06/2016
Ethics approval number [3] 298501 0
Ethics committee name [4] 298502 0
Tasmanian Health and Medical Research Ethics Committee
Ethics committee address [4] 298502 0
University of Tasmania
Private Bag 1
Hobart TAS 7001
Ethics committee country [4] 298502 0
Australia
Date submitted for ethics approval [4] 298502 0
21/03/2016
Approval date [4] 298502 0
08/06/2016
Ethics approval number [4] 298502 0
Ethics committee name [5] 298504 0
South Metropolitan Health Service HREC
Ethics committee address [5] 298504 0
Level 2, Southern Research Facility (Perkins building)
Fiona Stanley Hospital, 11 Robin Warren Drive, MURDOCH WA 6150
Ethics committee country [5] 298504 0
Australia
Date submitted for ethics approval [5] 298504 0
03/05/2016
Approval date [5] 298504 0
21/07/2016
Ethics approval number [5] 298504 0
Ethics committee name [6] 298505 0
Menzies School of Research HREC
Ethics committee address [6] 298505 0
PO BOX 41096
Casuarina NT 0811
Ethics committee country [6] 298505 0
Australia
Date submitted for ethics approval [6] 298505 0
05/08/2016
Approval date [6] 298505 0
14/11/2016
Ethics approval number [6] 298505 0

Summary
Brief summary
Contemporary Australian data suggest that pulmonary hypertension (PHT) is more common than previously reported and confers a poor prognosis, however this single-centre data needs confirmation in a large population study from many locations and diverse backgrounds. Identification of underlying cause and prognosis of PHT non-invasively using simple markers would have a major impact on the diagnosis and management of patients with PHT.

PHT is often identified during echocardiography, performed for investigation of breathlessness. PHT is not a diagnosis in itself, but has a number of underlying causes that require additional investigation to delineate. Such causes include left heart diseases, various chronic respiratory illnesses, and chronic thromboembolic and pulmonary vascular diseases.

Over 900,000 echocardiograms (echos) are performed in Australia each year, but to date there has been no systematic method for capturing data from these echos. The newly developed National Echo Database Australia (NEDA) is designed to obtain measurement and report data, but no images, from digital echo laboratory across Australia and transfer them to a secure database, matched against national mortality data. The NEDA database will be the largest echo database in the world.

Identification of the population of patients with PHT is of great importance, both to target those who may benefit from disease-specific therapy, and to better understand all forms of PHT in Australia and New Zealand. Abnormalities identifiable using echocardiography may be very useful prognostic indicators, and may help separate various causes for PHT. This information could be used to both identify patients who may respond to treatment, and to identify them earlier, with the goal of decreasing both morbidity and mortality for this common condition.
Trial website
www.neda.net.au
Trial related presentations / publications
Strange, G. et al., Disparity Between Severe Aortic Stenosis Prevalence and Aortic Valve Replacement Using the National Echo Database of Australia (NEDA), Abstracts for the 64th Cardiac Society of Australia and New Zealand Annual Scientific Meeting and the International Society for Heart Research Australasian Section Annual Scientific Meeting, 4 – 7 August 2016, Adelaide, Australia, Heart, Lung and Circulation, Volume 25, Supplement 2, S226.

Playford, D. et al., Making Australia the benchmark in Echocardiography databases: The National Echo Database Australia, Abstracts for the 64th Cardiac Society of Australia and New Zealand Annual Scientific Meeting and the International Society for Heart Research Australasian Section Annual Scientific Meeting, 4 – 7 August 2016, Adelaide, Australia, Heart, Lung and Circulation, Volume 25, Supplement 2, S560.

Chung, K. et al., The National Echo Database Australia (NEDA) and Pulmonary Hypertension, Abstracts for the 64th Cardiac Society of Australia and New Zealand Annual Scientific Meeting and the International Society for Heart Research Australasian Section Annual Scientific Meeting, 4 – 7 August 2016, Adelaide, Australia, Heart, Lung and Circulation , Volume 25 , Supplement 2, S122.

Chung, K. et al. Pulmonary Hypertension (PH) Due to Left Heart Disease: A Predictive Model Using the National Echo Database of Australia (NEDA), Heart, Lung and Circulation, Volume 26, S61.

Playford et al. Making Australia the Benchmark in Echocardiography Databases: The National Echo Database Australia (NEDA). Pulmonary Circulation 2017;7(1):1-7.

Kuppusamy, H. et al., The Echocardiographic Pulmonary to Left Atrial Ratio (ePLAR): Identifying Cause of Pulmonary Hypertension and Subsequent Mortality Risk, Heart, Lung and Circulation, Volume 26 , S273.

Chung et al, Pulmonary Hypertension due to Left Heart Disease: A predictive model using the National Echo Database of Australia. ESC 2017.
Public notes

Contacts
Principal investigator
Name 77198 0
Prof David Playford
Address 77198 0
School of Medicine
University of Notre Dame
32 Mouat Street,
Fremantle, WA 6959
Country 77198 0
Australia
Phone 77198 0
+61 8 9391 1234
Fax 77198 0
Email 77198 0
dplayford@neda.net.au
Contact person for public queries
Name 77199 0
A/Prof Geoff Strange
Address 77199 0
Cardiology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 77199 0
Australia
Phone 77199 0
+61 422 308 585
Fax 77199 0
Email 77199 0
gstrange@neda.net.au
Contact person for scientific queries
Name 77200 0
A/Prof Geoff Strange
Address 77200 0
Cardiology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 77200 0
Australia
Phone 77200 0
+ 61 422 308 585
Fax 77200 0
Email 77200 0
gstrange@neda.net.au

No data has been provided for results reporting
Summary results
Not applicable