Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001326886
Ethics application status
Approved
Date submitted
30/07/2021
Date registered
29/09/2021
Date last updated
30/11/2023
Date data sharing statement initially provided
29/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Western Australian Heart Valve Study
Scientific title
Assessment of long term health and patient reported outcomes in a cohort of West Australian patients with prior heart valve repair or replacement surgery.
Secondary ID [1] 304863 0
None
Universal Trial Number (UTN)
Trial acronym
WAVES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Valvular Heart Disease 322969 0
Condition category
Condition code
Cardiovascular 320544 320544 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Years
Description of intervention(s) / exposure
The WAVES study will involve the development of a registry of patients who have had a heart valve replacement or repair surgery at one of the tertiary hospitals in Perth, Western Australia since 2010.

The data will be linked with administrative data sets including death registrations and hospital morbidity.

The registry will be updated annually.

Consent will also be sought from all living registry participants to participate in a prospective observational study.

Long term outcomes and medication use will be ascertained using brief questionnaires that will be posted out to participants. Each will take approximately 5 minutes to complete.

Questionnaires to ascertain patient reported outcomes will also be mailed out to participants. These will include the EQ-5D-5L questionnaire for quality of life, DASI questionnaire for functional capacity and the WHODAS questionnaire for assessment of life disability. Each of these questionnaires will take approximately 5 minutes to complete.

These will be performed at enrolment and repeated at 2 years, and 4 years post-enrolment.

No additional testing/imaging will be required of living registry participants.
Intervention code [1] 321253 0
Diagnosis / Prognosis
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328364 0
Mortality, collected through linkage with the DDI.
Timepoint [1] 328364 0
Data collected annually, with no end date determined.
Primary outcome [2] 328365 0
Incidence of myocardial infarction, through information from a study-specific participant follow-up questionnaire and medical record review.
Timepoint [2] 328365 0
0, 2 and 4 years after addition to registry for each participant.
Primary outcome [3] 328752 0
Incidence of stroke, through information from a study-specific participant follow-up questionnaire and medical record review.
Timepoint [3] 328752 0
0, 2 and 4 years after addition to registry for each participant.
Secondary outcome [1] 398735 0
Quality of life (QoL) through the EQ-5D-5L questionnaire
Timepoint [1] 398735 0
0, 2 and 4 years after addition to registry for each participant.
Secondary outcome [2] 400237 0
Disability through the WHODAS questionnaire.
Timepoint [2] 400237 0
0, 2 and 4 years after addition to registry for each participant.
Secondary outcome [3] 400238 0
Functional capacity through the DASI questionnaire.
Timepoint [3] 400238 0
0, 2 and 4 years after addition to registry for each participant.
Secondary outcome [4] 400239 0
Major bleeding (primary outcome), through information from a study-specific participant follow-up questionnaire and medical record review.
Timepoint [4] 400239 0
0, 2 and 4 years after addition to registry for each participant.
Secondary outcome [5] 400240 0
Hospitalised heart failure (primary outcome), through information from a study-specific participant follow-up questionnaire and medical record review.
Timepoint [5] 400240 0
0, 2 and 4 years after addition to registry for each participant.
Secondary outcome [6] 400241 0
Infective endocarditis (primary outcome), through information from a study-specific participant follow-up questionnaire and medical record review.
Timepoint [6] 400241 0
0, 2 and 4 years after addition to registry for each participant.
Secondary outcome [7] 401210 0
Medication use, through information from a study-specific participant medication questionnaire.
Timepoint [7] 401210 0
0, 2 and 4 years after addition to registry for each participant.
Secondary outcome [8] 401211 0
Number of patients that are “lost”, or drop out, during the course of the registry, at what point they are lost, and if they return.
Timepoint [8] 401211 0
Analysed every 2 years at completion of each participant contact timepoint.

Eligibility
Key inclusion criteria
Heart valve repair or replacement surgery at Fiona Stanley Hospital, Sir Charles Gairdner Hospital or Royal Perth Hospital since 2010.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
A descriptive approach will be used to analyse the data. This includes summarising information from continuous variables (e.g., mean, median) or from categorical variables (e.g., proportions, rates). Study populations will be described using incidence and prevalence. The number of patients who encounter an adverse event (e.g. clinically significant bleeding, thrombosis, hospitalisation, mortality) will be determined, as will the number of patients that are “lost,” or drop out, during the course of the registry, at what point they are lost, and if they return. Quality of life, life disability and functional capacity questionnaires will be individually scored and analysed to assess each participant's perceived satisfaction in each individual domain of life.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2021
Actual
25/09/2021
Date of last participant enrolment
Anticipated
1/10/2030
Actual
Date of last data collection
Anticipated
1/10/2034
Actual
Sample size
Target
3000
Accrual to date
906
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20069 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 20070 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 20071 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 34775 0
6150 - Murdoch
Recruitment postcode(s) [2] 34776 0
6009 - Nedlands
Recruitment postcode(s) [3] 34777 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 309237 0
Charities/Societies/Foundations
Name [1] 309237 0
National Heart Foundation of Australia
Country [1] 309237 0
Australia
Primary sponsor type
Individual
Name
Professor Graham Hillis
Address
Department of Cardiology, Level 4, South Block, Royal Perth Hospital, Perth, WA, 6000
Country
Australia
Secondary sponsor category [1] 310203 0
None
Name [1] 310203 0
Address [1] 310203 0
Country [1] 310203 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309085 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 309085 0
Ethics committee country [1] 309085 0
Australia
Date submitted for ethics approval [1] 309085 0
19/08/2020
Approval date [1] 309085 0
22/02/2021
Ethics approval number [1] 309085 0
RGS0000004086
Ethics committee name [2] 311549 0
Department of Health WA HREC
Ethics committee address [2] 311549 0
Ethics committee country [2] 311549 0
Australia
Date submitted for ethics approval [2] 311549 0
18/03/2021
Approval date [2] 311549 0
13/05/2021
Ethics approval number [2] 311549 0
RGS0000004086

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

Contacts
Principal investigator
Name 112918 0
Prof Graham Hillis
Address 112918 0
Department of Cardiology,
Level 4, South Block,
Royal Perth Hospital,
Victoria Square,
Perth, WA, 6000
Country 112918 0
Australia
Phone 112918 0
+61 8 9224 3180
Fax 112918 0
Email 112918 0
[email protected]
Contact person for public queries
Name 112919 0
Primero Ng
Address 112919 0
Department of Cardiology,
Level 4, South Block,
Royal Perth Hospital,
Victoria Square,
Perth, WA, 6000
Country 112919 0
Australia
Phone 112919 0
+61 8 9224 2244
Fax 112919 0
Email 112919 0
[email protected]
Contact person for scientific queries
Name 112920 0
Primero Ng
Address 112920 0
Department of Cardiology,
Level 4, South Block,
Royal Perth Hospital,
Victoria Square,
Perth, WA, 6000
Country 112920 0
Australia
Phone 112920 0
+61 8 9224 2244
Fax 112920 0
Email 112920 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


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.