Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000531415
Ethics application status
Approved
Date submitted
25/10/2024
Date registered
27/05/2025
Date last updated
27/05/2025
Date data sharing statement initially provided
27/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the prevalence of Postural Orthostatic Tachycardia Syndrome (POTS) in patients attending the emergency department (ED) with orthostatic symptoms.
Scientific title
Determining the prevalence of Postural Orthostatic Tachycardia Syndrome (POTS) in patients attending the emergency department (ED) with orthostatic symptoms.
Secondary ID [1] 313252 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysautonomia 335571 0
Postural Orthostatic Tachycardia Syndrome 335570 0
Condition category
Condition code
Other 332142 332142 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Neurological 332141 332141 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to identify the prevalence of Postural Orthostatic Tachycardia Syndrome (POTS) in patients who attend the emergency department with symptoms consistent with this condition, using a novel diagnostic pathway. Eligible participants will be identified via review of relevant Internal Classification of Diseases (ICD) coding, as determined to be appropriate by the research team.

The MALMO POTS questionnaire is a self-assessment symptom score that was developed in 2022. It is based on self-reported severity of twelve commonly reported POTS symptoms including five cardiac and seven non-cardiac symptoms. It has been validated as a useful screening tool for POTS, with a score of 42 or greater yielding 97% sensitivity and 98% specificity for the presence of POTS compared to a normative population.

Patients will be invited to participate in the study following review of emergency department discharge paperwork by the research team. Patients will be invited via post in collaboration with their clinical treating team, and if happy to receive further information, consent and completion of the survey will be done via electronic link to a REDCap database. The survey will take approximately 5- 10 minutes to complete.

For participants who score 42 or greater in the questionnaire, they will progress to the second stage of the study; formal objective autonomic testing to quantify the presence of POTS. This will require attendance at a private clinic, with testing conducted by clinical nurses and research officers. Testing will include a 12-lead ECG, sudomotor function testing with the SUDOSCAN equipment, and autonomic testing with The Finapres Nova, including Ten-minute Active Stand Test using beat to beat hemodynamic monitoring, the Valsalva manoeuvre, a deep breathing test, and a baroreceptor sensitivity test. The clinic visit will take approximately 30- 60 minutes. Baseline demographics, medical history and medications use will also be collected. Testing will be completed within 6-months of emergency presentation.

For participants who meet the criteria for POTS based on the Active Stand Test, results of autonomic testing will be forwarded to their General Practitioner (GP) to allow for appropriate follow up.
Intervention code [1] 329831 0
Early detection / Screening
Intervention code [2] 329830 0
Diagnosis / Prognosis
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339722 0
MALMO POTS Score
Timepoint [1] 339722 0
There is no follow up testing required for this study. Autonomic testing will be completed only once within 6 months of ED presentation.
Primary outcome [2] 339721 0
POTS diagnosis (delta heart rate)
Timepoint [2] 339721 0
Within 6 months of emergency department (ED) presentation
Secondary outcome [1] 440996 0
Fatigue
Timepoint [1] 440996 0
Once within 6 months of ED Visit at time of Autonomic Testing
Secondary outcome [2] 440997 0
Functionality
Timepoint [2] 440997 0
Once within 6 months of ED Visit at time of Autonomic Testing
Secondary outcome [3] 440995 0
Gastrointestinal Symptom Burden
Timepoint [3] 440995 0
Once within 6 months of ED Visit at time of Autonomic Testing
Secondary outcome [4] 440998 0
Anxiety
Timepoint [4] 440998 0
Once within 6 months of ED Visit at time of Autonomic Testing
Secondary outcome [5] 440999 0
Health Related Quality of Life
Timepoint [5] 440999 0
Once within 6 months of ED Visit at time of Autonomic Testing
Secondary outcome [6] 440994 0
Autonomic symptom burden
Timepoint [6] 440994 0
Once within 6 months of ED Visit at time of Autonomic Testing
Secondary outcome [7] 441000 0
Healthcare Utilisation
Timepoint [7] 441000 0
Once within 6 months of ED Visit at time of Autonomic Testing

Eligibility
Key inclusion criteria
• Adults aged greater or equal to 18 years old and less than or equal to 65 years old (male or female)
• Able to provide written consent
• Continuing chronic orthostatic symptoms persisting for 3 months or greater at time of testing.
Orthostatic symptoms may include tachycardia, light-headedness, dizziness, pre syncope,
syncope, dyspnoea, tremulousness, palpitations, chest pain, and fatigue.
• Symptoms not attributable to an alternative disease state.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Non-consent for participation in study
• Pregnancy
• Other known cause of autonomic dysfunction
• Prior diagnosis of POTS or dysautonomia
• Co-morbidities such as Parkinson’s Disease, multiple sclerosis, alcoholism, drug addiction,
malignant neoplasm, recent cerebrovascular accident or transient ischemic attack (within 3
months of ED presentation), heart failure or recent myocardial infarction (within 3 months of
ED presentation), acquired brain injury
• Inability to provide informed consent
• Unavailability for completion of all assessments as per the study protocol
• Non-English speaker

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
1/08/2026
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 27961 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 44153 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 317698 0
University
Name [1] 317698 0
The University of Adelaide
Country [1] 317698 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 320019 0
Hospital
Name [1] 320019 0
The Royal Adelaide Hospital
Address [1] 320019 0
Country [1] 320019 0
Australia
Secondary sponsor category [2] 321487 0
Hospital
Name [2] 321487 0
The Australian POTS Foundation
Address [2] 321487 0
Country [2] 321487 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316394 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 316394 0
Ethics committee country [1] 316394 0
Australia
Date submitted for ethics approval [1] 316394 0
Approval date [1] 316394 0
11/09/2024
Ethics approval number [1] 316394 0

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

Contacts
Principal investigator
Name 137758 0
Dr Celine Gallagher
Address 137758 0
c/- Lifelong Health South Australian Health and Medical Research Institute North Terrace ADELAIDE SA 5000
Country 137758 0
Australia
Phone 137758 0
+61 08 8317 5300
Fax 137758 0
Email 137758 0
[email protected]
Contact person for public queries
Name 137759 0
Gemma Wilson
Address 137759 0
c/- Lifelong Health South Australian Health and Medical Research Institute North Terrace ADELAIDE SA 5000
Country 137759 0
Australia
Phone 137759 0
+61 08 8317 5300
Fax 137759 0
Email 137759 0
[email protected]
Contact person for scientific queries
Name 137760 0
Gemma Wilson
Address 137760 0
c/- Lifelong Health South Australian Health and Medical Research Institute North Terrace ADELAIDE SA 5000
Country 137760 0
Australia
Phone 137760 0
+61 08 8317 5300
Fax 137760 0
Email 137760 0
[email protected]

Data sharing statement
Will the study consider sharing 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.