RecruitingACTRN12625000058471

Are the postural orthostatic tachycardia syndrome diagnostic criteria limiting? Defining and comparing patient reported outcomes of an Australian cohort with postural symptoms without tachycardia


Sponsor

University of Adelaide

Enrollment

500 participants

Start Date

Oct 28, 2024

Study Type

Observational

Conditions

Summary

Postural orthostatic tachycardia syndrome (POTS) is a multisystem, autonomic disorder that culminates in extensive morbidity for those affected. POTS is currently diagnosed on the basis of strict heart rate response to a standing test in addition to the presence of orthostatic symptoms for greater than 3 months unexplained by another condition. However, the heart rate criterion is confounded by multiple factors and has not previously been well validated to correlate with symptoms. Additionally, little is known about whether individuals with postural symptoms without tachycardia (PSWT) have similar symptom burden and health related quality of life impairment to those with POTS. As such, we will explore the symptom burden of PSWT patients and compare this to a POTS cohort.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Postural orthostatic tachycardia syndrome (POTS) is a condition affecting the autonomic nervous system — the part of the body that controls automatic functions like heart rate, blood pressure, and digestion. People with POTS typically experience a very fast heart rate when standing up, along with symptoms like dizziness, fatigue, palpitations, and fainting. However, some people experience all of these symptoms without meeting the strict heart rate criteria for a POTS diagnosis, and it is unclear whether their experiences and quality of life are similarly affected. This study is exploring the symptom burden, quality of life, and health outcomes of people with 'postural symptoms without tachycardia' (PSWT) and comparing them to a cohort of patients with confirmed POTS. The researchers are using existing data from the Australian OZ-POTS registry to understand whether the current diagnostic criteria for POTS may be excluding people who are equally impacted. This is a registry-based study using previously collected data — no new procedures are required. You may be eligible if you are aged 18 or older, have had a thorough cardiac evaluation including a standing test, ECG, echocardiogram, and Holter monitor, and have consented for your de-identified data to be used in research. You must be able to complete patient-reported surveys in English. Non-English speakers or those who have not provided consent for their data to be used in research would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 t

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).


Locations(1)

SA, Australia

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ACTRN12625000058471


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