Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)

ConditionPostural Orthostatic Tachycardia Syndrome

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age14+

SponsorUniversity of Texas Southwestern Medical Center

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Healthy women, age 18 - 30 years, able to provide informed consent and comply with study procedures

Disqualifiers

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

Trial population

POTS patients and Normal Control

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

multimodal diagnostic testing
Diagnostic test
Serological testing, cardiac MRI, skin biopsy, cardiovascular testing, blood volume measurements

Treatment groups

350 Participants

are divided into 2 treatment groups

Group A: POTS (Postural Orthostatic Tachycardia Syndrome)1 intervention

Group B: Healthy matched controls1 intervention

Trial outcomes

Primary outcomes

Phenotyping POTS

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

Time frame

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

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

Apply now