Actively Recruiting

Age: 14Years +
All Genders
Healthy Volunteers
ID06292104

Multimodality Deep Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS), Aim 1

Led by University of Texas Southwestern Medical Center · Updated on 2025-06-27

350

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University of Texas Southwestern Medical Center

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting an observational study to deeply understand Postural Orthostatic Tachycardia Syndrome (POTS) using various testing methods. This study aims to improve diagnosis, guide new treatments, and tailor therapies for specific POTS patients. The investigators also seek to identify the most relevant diagnostic tools, biomarkers, and clinical outcome measures for practical use. The study involves detailed testing including blood work for immune and neurohormonal assessments, autonomic function tests, skin biopsies to check nerve fiber density, carbon monoxide rebreathing to measure blood volume, and patient surveys to capture symptoms and disease impact. Blood samples will also be stored for future research. Participants include patients with POTS and healthy controls matched by age and sex. Participants will undergo a comprehensive evaluation over about two weeks for phenotyping and then be followed for one year to observe the natural history of POTS. Assessments include clinical data, laboratory tests, and questionnaires. Researchers will monitor these results to better classify POTS, assess exercise tolerance, and evaluate patient outcomes over time.

CONDITIONS

Brief Title

Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)

Who Can Participate

Age: 14Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 years or older, able to provide informed consent (or assent with parental consent if under 18) and comply with procedures
  • POTS patients meeting consensus criteria: sustained increase in heart rate ≥30 bpm (≥40 bpm if aged 12-19) within 10 minutes of standing or upright tilt, no orthostatic hypotension, symptoms improve with sitting or lying down, resting supine heart rate <100 bpm, symptoms present for at least 6 months
  • Stable oral medication regimen for at least 14 days
  • Healthy women aged 18-30 years for control group, able to provide informed consent and comply with procedures
  • Controls do not meet POTS criteria and have no orthostatic intolerance or major medical disorders
  • Resting supine heart rate <100 bpm for controls
Not Eligible

You will not qualify if you...

  • Use of amphetamine-type stimulants, diuretics, selective norepinephrine reuptake inhibitors, anticholinergic medications (including tricyclic antidepressants), fludrocortisone, or desmopressin in past 14 days
  • Use of autonomic drugs (adrenergic agents, pyridostigmine, droxidopa, triptans, ivabradine) in past 48 hours
  • Currently receiving IVIG, subcutaneous IgG, or any investigational medication in past year
  • Infusion of intravenous fluids in past 7 days
  • History or evidence of other conditions explaining symptoms or orthostatic tachycardia, such as structural heart disease, cerebrospinal fluid hypovolemia, or severe traumatic brain injury

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 2 weeks

Participants undergo comprehensive multimodal diagnostic testing including blood work, autonomic function testing, skin biopsy, cardiac MRI, and blood volume measurements to characterize POTS.

1 to 2 visits depending on testing procedures

Long-term Monitoring

Duration - 1 year

Participants are followed for one year to collect outcome data and better understand the natural history of POTS.

Follow-up visits scheduled as needed over 1 year

Trial Site Locations

Total: 1 location

1

UT Southwestern Medical Center

Dallas, Texas, United States, 75208

Actively Recruiting

Loading map...

Research Team

S

Steve Hopkins

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Similar Trials

Hypermobile Ehlers-Danlos Syndrome: Efficacy of Non-invasive...

Functional Gastrointestinal Disorders

Actively Recruiting

1 location

CAlgary SAlt for Postural Orthostatic Tachycardia Syndrome S...

Postural Orthostatic Tachycardia Syndrome

Actively Recruiting

1 location

Compression Garments in the Community With Postural Orthosta...

Postural Orthostatic Tachycardia Syndrome

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Postural orthostatic tachycardia syndrome (POTS): Priorities for POTS care and research from a 2019 National Institutes of Health Expert Consensus Meeting - Part 2.

Satish R Raj, Kate M Bourne, Lauren E Stiles...

https://pubmed.ncbi.nlm.nih.gov/34246578