Deep phenotyping of Postural Orthostatic Tachycardia Syndrome

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

This study is trying to better understand Postural Orthostatic Tachycardia Syndrome (POTS) by looking at different tests and samples from patients to improve diagnosis and treatment options.

Quick facts

• Study type: Observational
• Enrollment: 350 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (Academic / other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT06292104 on ClinicalTrials.gov

What this trial studies

This observational study aims to deeply phenotype Postural Orthostatic Tachycardia Syndrome (POTS) using various diagnostic modalities. The approach includes defining clinical classifications, assessing exercise tolerance through metabolomic evaluations, and identifying relevant biomarkers and clinical outcome measures. By utilizing blood work, autonomic function testing, skin biopsies, and patient surveys, the study seeks to enhance diagnostic accuracy and inform future treatment strategies for POTS patients. Additionally, a repository of blood biosamples will be established for future research.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 14 years and older who meet the consensus criteria for POTS.

Not a fit: Patients who do not have POTS or exhibit symptoms of orthostatic intolerance will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and targeted therapies for patients with POTS.

How similar studies have performed: While the approach of deep phenotyping is innovative, similar studies have shown promise in enhancing understanding and treatment of complex syndromes.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

None of the following exclusion criteria:

* 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)

Where this trial is running

Dallas, Texas

• UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Steven Vernino, MD PhD — University of Texas Southwestern Medical Center
• Study coordinator: Steve Hopkins

Conditions Postural Orthostatic Tachycardia Syndrome