Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)

NCT06292104 | Recruiting

• 2 other identifiers: STU-2023-05891R01HL166272-01A1
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study to deeply phenotype the disorder of POTS using multiple testing modalities.

Conditions

Postural Orthostatic Tachycardia Syndrome

Outcome Measures

Primary Outcomes (2)

• Phenotyping POTS

  Assignment of participant to a phenotypic group(s) based on analysis of multimodal data

  2 weeks

• Natural history

  Patient reported functional and subjective change. Surveys including COMPASS31 (Composite Autonomic Symptom Score-31) on a score of 0-100. Higher scores indicate more severe autonomic symptoms

  1 year

Study Arms (2)

POTS (Postural Orthostatic Tachycardia Syndrome)

Patients meeting clinical criteria for postural orthostatic tachycardia syndrome who meet other criteria for inclusion.

Diagnostic Test: multimodal diagnostic testing

Healthy matched controls

Age and sex matched controls

Diagnostic Test: multimodal diagnostic testing

Interventions

multimodal diagnostic testing DIAGNOSTIC_TEST

Serological testing, cardiac MRI, skin biopsy, cardiovascular testing, blood volume measurements

Healthy matched controls; POTS (Postural Orthostatic Tachycardia Syndrome)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

POTS patients and Normal Control

You may qualify if:

• POTS Patients
• Age ≥ 14 years, able to provide informed consent (assent with parental consent for age \< 18) and comply with procedures
• Meets consensus criteria for POTS: (1) sustained increase in heart rate ≥ 30 bpm above supine baseline within 10 min of quiet standing or upright tilt (≥ 40 bpm in individuals 12 to 19 years of age) OR sustained upright HR (heart rate) \>120 bpm, (2) absence of orthostatic hypotension, (3) symptoms with standing that improve with sitting or lying down, (4) resting supine heart rate \< 100 bpm, (5) orthostatic symptoms present for at least 6 months
• Stable oral medication regimen for at least 14 days
• Non-POTS Control Patients
• Healthy women, age 18 - 30 years, able to provide informed consent and comply with study procedures
• Does NOT meet consensus criteria for postural tachycardia syndrome
• No symptoms of orthostatic intolerance or dysautonomia. No history of other major medical disorder
• Resting supine heart rate \< 100 bpm

You may not qualify if:

• Use of amphetamine-type stimulants, diuretics, selective norepinephrine reuptake inhibitor, anticholinergic medications (including tricyclic antidepressant medications), fludrocortisone, desmopressin in past 14 days
• Use of other autonomic drugs (adrenergic agents, pyridostigmine, droxidopa, triptans, ivabradine) in past 48 hours
• Currently receiving IVIG (Intravenous immunoglobulin), subcutaneous IgG (Immunoglobulin G), or any investigational medication (in past year)
• Infusion of iv fluids in past 7 days
• History or evidence of another condition explaining symptoms or orthostatic tachycardia (e.g. structural heart disease, CSF (Cerebrospinal fluid) hypovolemia, or severe traumatic brain injury)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75208, United States

RECRUITING

Related Publications (2)

• Raj SR, Bourne KM, Stiles LE, Miglis MG, Cortez MM, Miller AJ, Freeman R, Biaggioni I, Rowe PC, Sheldon RS, Shibao CA, Diedrich A, Systrom DM, Cook GA, Doherty TA, Abdallah HI, Grubb BP, Fedorowski A, Stewart JM, Arnold AC, Pace LA, Axelsson J, Boris JR, Moak JP, Goodman BP, Chemali KR, Chung TH, Goldstein DS, Darbari A, Vernino S. Postural orthostatic tachycardia syndrome (POTS): Priorities for POTS care and research from a 2019 National Institutes of Health Expert Consensus Meeting - Part 2. Auton Neurosci. 2021 Nov;235:102836. doi: 10.1016/j.autneu.2021.102836. Epub 2021 Jun 30.

  PMID: 34246578 BACKGROUND

• Bryarly M, Phillips LT, Fu Q, Vernino S, Levine BD. Postural Orthostatic Tachycardia Syndrome: JACC Focus Seminar. J Am Coll Cardiol. 2019 Mar 19;73(10):1207-1228. doi: 10.1016/j.jacc.2018.11.059.

  PMID: 30871704 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma and samples with DNA

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• Steven Vernino, MD PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steve Hopkins

CONTACT

214-648-9275; steve.hopkins@utsouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 4, 2024
• Study Start: March 5, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

US (1)