Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001034820
Ethics application status
Approved
Date submitted
18/04/2021
Date registered
5/08/2021
Date last updated
1/09/2024
Date data sharing statement initially provided
5/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Australian Postural Orthostatic Tachycardia Syndrome Patient Registry
Scientific title
The Australian Postural Orthostatic Tachycardia Syndrome Patient Registry (Oz-POTS)
Secondary ID [1] 303990 0
nil known
Universal Trial Number (UTN)
Trial acronym
(Oz-POTS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postural Orthostatic tachycardia Syndrome 321601 0
Condition category
Condition code
Cardiovascular 319341 319341 0 0
Other cardiovascular diseases
Neurological 319737 319737 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Postural orthostatic tachycardia syndrome (POTS) is heterogenous disorder characterized by postural induced tachycardia, dizziness, fatigue, malaise, exercise intolerance and a myriad of concomitant symptoms such as poor sleep quality, centralised pain, headache, impaired cognitive ability, reproductive, gastrointestinal and urinary dysfunction. The syndrome disproportionally affects young women (ratio 5:1) and is associated with significantly reduced quality of life (QOL) and increased morbidity; rendering a reported 25% of suffers unable to work.
The Australian Postural Tachycardia Syndrome Patient Registry (Oz-POTS) will collect data on at least 100 patients who attend the specialist POTS clinic run by Dr Dennis Lau, Professor at The Australian Dysatuonomia and Arrhythmia Research Collaboration , Adelaide, Australia (ADARC). The aim of the registry is to characterise individuals with postural orthostatic tachycardia syndrome (POTS), in addition to identifying those who may be interested in participating in future clinical research. Data will be collected for 5 years. The University of Adelaide, Centre for Heart Rhythm Disorders will serve as the Registry Data Coordinating Centre and will manage data entered into the web based, REDCap program.
Consent will allow:
- transfer of relevant deidentified patient medical information from medical notes into database
-initial semi-structured interview by phone to confirm and complete medical data.
- complete yearly health related questionnaires by electronic link including a medical history update form and socio-economic status details as well as POTS related health questionnaires.
Intervention code [1] 320294 0
Not applicable
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327207 0
Economic costs for patients with POTS assessed by calculating difference between resource use and costs from medical records.
Timepoint [1] 327207 0
Costs for one year will be assessed in any year during the 5 years of observation. Additionally, accumalative costs over 5 years will be determined.
Secondary outcome [1] 394213 0
Quality of life of those with POTS assessed using EQ5-5D-5L
Timepoint [1] 394213 0
Quality of life for will be assessed in any year during the 5 years of observation. and will be assessed annually
Secondary outcome [2] 394214 0
Autonomic function of those with POTS assessed using Compass-31 and autonomic diagnostic results from medical records
Timepoint [2] 394214 0
Autonomic function at one point in time will be assessed in any year during the 5 years of observation . As this is retrospective data, only available autonomic testing data contained in the medical records will be assessed. This may change in terms of time points for each patient according to their diagnostic journey and previous assessments.
Secondary outcome [3] 394215 0
Prevalence of comorbidities amongst those with POTS as determined by medical diagnosis from medical records
Timepoint [3] 394215 0
Comorbidities assessed annually for 5 years
Secondary outcome [4] 394216 0
Quality of life of those with POTS assessed using SF-36
Timepoint [4] 394216 0
Quality of life assessed annually for 5 years
Secondary outcome [5] 395910 0
Orthostatic symptomology of those with POTS assessed using Orthostatic Hypotension Questionnaire
Timepoint [5] 395910 0
Symptomology assessed annually for 5 years,
Secondary outcome [6] 395911 0
Hypermobility scores of those with POTS assessed using the 5 point hypermobility score
Timepoint [6] 395911 0
This is a static condition and will be assessed at any point in the 5 years according to the clinical assessment of the patient.
Secondary outcome [7] 395912 0
Neuroendocrine function in those with POTS assessed using urinary symptom history, blood and urinary pathology results from medical notes
Timepoint [7] 395912 0
Function assessed annually for 5 years
Secondary outcome [8] 395913 0
Prevalence of migraine in POTS as assessed by diagnostic investigation and medical history from medical records
Timepoint [8] 395913 0
Prevalence assessed annually for 5 years
Secondary outcome [9] 395914 0
Diagnostic delay in POTS as assessed by calculating onset of symptoms to diagnosis as per medical records
Timepoint [9] 395914 0
Onset of symptoms and time to diagnosis will be assessed at one point in time in the first year
Secondary outcome [10] 395915 0
Emergency and hospital admissions in POTS as assessed by discharge documentation contained in medical notes (composite secondary outcome)
Timepoint [10] 395915 0

Hospital admission assessed annually for 5 years
Secondary outcome [11] 395916 0
Characteristics of echocardiogram in POTS (exploratory) as assessed through retrospective analysis of echocardiogram outcomes
Timepoint [11] 395916 0
data for one year will be assessed in any year during the 5 years of observation
Secondary outcome [12] 395917 0
Characteristics of Holter monitor data in POTS as assessed by retrospective analysis of Holter tests in medical records
Timepoint [12] 395917 0
data for one year will be assessed in any year during the 5 years of observation
Secondary outcome [13] 395918 0
Gastrointestinal disturbance in POTS as assessed using the Cardinal Gastroparesis symptom score and COMPASS-31
Timepoint [13] 395918 0
Symptomology, assessed annually for 5 years
Secondary outcome [14] 395919 0
Impacts of IV fluid therapy in those with POTS as determined by changes in outcomes of health related questionnaires from medical records (SF-36, Eq-5D-5l, COMPASS-31)
Timepoint [14] 395919 0
Symptomology for one year will be assessed in any year during the 5 years of observation
Secondary outcome [15] 395920 0
Safety of IV fluid therapy via port in POTS assessed by reviewing rates of infection and clots from medical records
Timepoint [15] 395920 0
Symptomology for one year will be assessed in any year during the 5 years of observation
Secondary outcome [16] 395921 0
Rates of neurocognitive disorder amongst those with POTS as assessed by reviewing diagnosis in medical records
Timepoint [16] 395921 0
Rates for one year will be assessed in any year during the 5 years of observation
Secondary outcome [17] 395922 0
Medication use in those with POTS assessed by review of medical records and linkage data from PBS
Timepoint [17] 395922 0
Useage for one year will be assessed in any year during the 5 years of observation
Secondary outcome [18] 397704 0
Demographic characterisation of patients with POTS as assessed by study specific survey
Timepoint [18] 397704 0
Assessed any one year in the five year time frame
Secondary outcome [19] 397705 0
Socioeconomic status of patients with POTS as assessed via medical record review
Timepoint [19] 397705 0
Assessed for one year of any of the five years
Secondary outcome [20] 413520 0
The FSS is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, and the final score represents the mean value of the 9 items. This is a validated instrument.
Timepoint [20] 413520 0
At entry to registry and yearly until timepoint end at 5 years
Secondary outcome [21] 428268 0
MALMO POTS Symptom score
Timepoint [21] 428268 0
Secondary outcome [22] 428269 0
MALMO POTS Symptom score
Timepoint [22] 428269 0
Yearly for 5 years

Eligibility
Key inclusion criteria
Inclusion Criteria
16 years old or older
Understand and sign the informed consent document
POTS diagnosis must be made / confirmed at a participating Registry centre.
The diagnostic evaluation must include, at a minimum, a medical history, physical examination, standing test/tilt table test, ECG, echocardiogram, Holter monitor
Diagnostic criteria for POTS met as per the following: sustained heart rate elevation of greater than 30 beats/min within 10 minutes (greater than 40 beats/min in adolescents). No other secondary cause of these symptoms. Greater than 3 months since onset of orthostatic intolerance symptoms.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
Non-consent for participation in registry
Non-English Speaker
Terminal illness

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Continuous variables will be reported as mean and standard deviation, or median and interquartile range, as appropriate to distribution. Count variables will be reported as numbers and percentages. Categorical variables will be evaluated using a chi-square or Fisher exact test as appropriate. All statistical tests will be two-sided, and a p value of <0.05 will be considered significant. All analyses will be undertaken using Stata 13.0 (Stata Corporation).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/08/2021
Actual
20/08/2021
Date of last participant enrolment
Anticipated
30/04/2029
Actual
Date of last data collection
Anticipated
30/11/2031
Actual
Sample size
Target
1000
Accrual to date
600
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 34834 0
5068 - Kensington Park
Recruitment postcode(s) [2] 38416 0
5068 - Kensington

Funding & Sponsors
Funding source category [1] 308372 0
University
Name [1] 308372 0
The University of Adelaide
Country [1] 308372 0
Australia
Funding source category [2] 315084 0
Other Collaborative groups
Name [2] 315084 0
South Australian Health and Medical Research Instute
Country [2] 315084 0
Australia
Funding source category [3] 315106 0
Other Collaborative groups
Name [3] 315106 0
South Australian Health and Medical Research Instute
Country [3] 315106 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
School of Medicine
The University of Adelaide
North Terrace, SA 5000
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 309190 0
None
Name [1] 309190 0
Address [1] 309190 0
Country [1] 309190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308338 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 308338 0
Ethics committee country [1] 308338 0
Australia
Date submitted for ethics approval [1] 308338 0
17/03/2021
Approval date [1] 308338 0
16/04/2021
Ethics approval number [1] 308338 0
H-2021-052

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

Contacts
Principal investigator
Name 110358 0
Prof Dennis Lau
Address 110358 0
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000
AUSTRALIA
Country 110358 0
Australia
Phone 110358 0
+610452646375
Fax 110358 0
Email 110358 0
[email protected]
Contact person for public queries
Name 110359 0
Marie-Claire Seeley
Address 110359 0
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000
AUSTRALIA
Country 110359 0
Australia
Phone 110359 0
+610438392919
Fax 110359 0
Email 110359 0
[email protected]
Contact person for scientific queries
Name 110360 0
Dennis Lau
Address 110360 0
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000
AUSTRALIA
Country 110360 0
Australia
Phone 110360 0
+610452646375
Fax 110360 0
Email 110360 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only
When will data be available (start and end dates)?
Following publication. No end date determined.
Available to whom?
Case by case discretion of Primary Sponsor to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
For any 'unspecified' purpose.
How or where can data be obtained?
[email protected]


What supporting documents are/will be available?




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.