Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000058471
Ethics application status
Approved
Date submitted
4/09/2024
Date registered
21/01/2025
Date last updated
21/01/2025
Date data sharing statement initially provided
21/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are the postural orthostatic tachycardia syndrome diagnostic criteria limiting? Defining and comparing patient reported outcomes of an Australian cohort with postural symptoms without tachycardia
Scientific title
Are the postural orthostatic tachycardia syndrome diagnostic criteria limiting? Defining and comparing patient reported outcomes of an Australian cohort with postural symptoms without tachycardia
Secondary ID [1] 312236 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12621001034820 - will be used to provide POTS comparison cohort

Health condition
Health condition(s) or problem(s) studied:
Dysautonomia 333935 0
Postural orthostatic tachycardia syndrome 333936 0
Condition category
Condition code
Neurological 330607 330607 0 0
Other neurological disorders
Cardiovascular 330608 330608 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Study of patients with postural symptoms without tachycardia (PSWT) to evaluate symptom burden and health related quality of life by sequential patient reported outcome surveys (PROMS) which include treatment approach. The initial surveys will be gathered from medical data with the single timepoint follow up survey gathered prospectively beyond 10 months from initial review via email. PSWT patients are those with symptoms that have undergone a postural orthostatic tachycardia syndrome (POTS) work-up including ECG/ holter and tilt table test but, have not met the heart rate criteria (an increase >30 beats per minute within 10 minutes of standing).
Intervention code [1] 328686 0
Diagnosis / Prognosis
Comparator / control treatment
Above data on PSWT will be compared to PROMS from POTS patients in the Australian Postural Orthostatic Tachycardia Syndrome Patient Registry (Oz-POTS). With POTS patient diagnosis being based on international criteria. ACTRN12621001034820
Control group
Historical

Outcomes
Primary outcome [1] 340008 0
Autonomic dysfunction symptom burden
Timepoint [1] 340008 0
baseline and long-term follow up (at least 10 months after initial work-up)
Primary outcome [2] 338360 0
Autonomic dysfunction symptom burden
Timepoint [2] 338360 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [1] 442284 0
Prevalence of anxiety
Timepoint [1] 442284 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [2] 442292 0
Prevalence of depression
Timepoint [2] 442292 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [3] 442295 0
Prevalence of endometriosis
Timepoint [3] 442295 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [4] 442298 0
Prevalence of hypermobile spectrum disorder
Timepoint [4] 442298 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [5] 437505 0
Comparison of PSWT gastrointestinal symptom burden to that of POTS patients
Timepoint [5] 437505 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [6] 440778 0
Comparison of PSWT fatigue severity to that of POTS patients
Timepoint [6] 440778 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [7] 442285 0
Prevalence of ADHD/ADD
Timepoint [7] 442285 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [8] 442301 0
Prevalence of mast cell activation disorder
Timepoint [8] 442301 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [9] 442288 0
Austism spectrum disorder
Timepoint [9] 442288 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [10] 442286 0
prevalence of asthma
Timepoint [10] 442286 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [11] 442299 0
Prevalence of iron deficiency
Timepoint [11] 442299 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [12] 442304 0
Prevalence of polycystic ovary syndrome
Timepoint [12] 442304 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [13] 442290 0
Chronic fatigue syndrome
Timepoint [13] 442290 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [14] 437504 0
Comparison of PSWT patient quality of life to that of POTS patients
Timepoint [14] 437504 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [15] 442300 0
Prevalence of irritable bowel syndrome
Timepoint [15] 442300 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [16] 442291 0
prevalence of coeliac disease
Timepoint [16] 442291 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [17] 442294 0
Prevalence of ehlers danlos syndrome
Timepoint [17] 442294 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [18] 442296 0
Prevalence of fibromyalgia
Timepoint [18] 442296 0
baseline and long-term follow up (at least 10 months after initial work-up)
Secondary outcome [19] 442303 0
Prevalence of mirgraine
Timepoint [19] 442303 0
baseline and long-term follow up (at least 10 months after initial work-up)

Eligibility
Key inclusion criteria
- 18 years old or older
- Understand and willing to sign the informed consent document
- The diagnostic evaluation must include, at a minimum, a medical history, physical
examination, standing test/tilt table test, ECG, echocardiogram, Holter monitor

- the above inclusion criteria will be applied to retrospective data available in the Oz-POTS registry (ACTRN12621001034820)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Non-consent for use of de-identified data in research
- Non-English speaker [or those who are unable to complete patient reported outcome measure surveys in English]
- Inability to provide consent due to vulnerable states or young age.

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, with evaluation via the student’s t-test or wilcoxon signed rank test. 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 SPSS.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/10/2024
Date of last participant enrolment
Anticipated
27/03/2025
Actual
Date of last data collection
Anticipated
4/04/2025
Actual
Sample size
Target
500
Accrual to date
70
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 316787 0
University
Name [1] 316787 0
University of Adelaide
Country [1] 316787 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 319008 0
None
Name [1] 319008 0
Address [1] 319008 0
Country [1] 319008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315397 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 315397 0
Ethics committee country [1] 315397 0
Australia
Date submitted for ethics approval [1] 315397 0
17/10/2023
Approval date [1] 315397 0
23/02/2024
Ethics approval number [1] 315397 0
H-2024-028

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

Contacts
Principal investigator
Name 134574 0
Prof Dennis Lau
Address 134574 0
Royal Adelaide Hospital Cardiology 4G751-769 The University of Adelaide Port Rd. SA 5000
Country 134574 0
Australia
Phone 134574 0
+610452646375
Fax 134574 0
Email 134574 0
[email protected]
Contact person for public queries
Name 134575 0
Celine Gallagher
Address 134575 0
SAHMRI, North Terrace, Adelaide SA 5000
Country 134575 0
Australia
Phone 134575 0
+61 08 83175300
Fax 134575 0
Email 134575 0
[email protected]
Contact person for scientific queries
Name 134576 0
Celine Gallagher
Address 134576 0
SAHMRI, North Terrace, Adelaide SA 5000
Country 134576 0
Australia
Phone 134576 0
+61 08 83175300
Fax 134576 0
Email 134576 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• after de-identification: omdovodia; participant data underlying published results only

What types of analyses could be done with individual participant data?
• any

When can requests for individual participant data be made (start and end dates)?
From:
immediately following publication, and ending 5 years following collection

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• by emailing the scientific contact: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.