Assessment of Antibodies and Inflammatory Markers in Postural Tachycardia Syndrome

NCT02196376 | Active Not Recruiting

• 1 other identifier: 140671
• Study Type: observational
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

In this pilot study, the investigators will test the hypothesis that patients with postural tachycardia syndrome will have an elevated percentage of functional antibodies to adrenergic receptors compared with control subjects without POTS. The investigators further hypothesize that the percentage of POTS patients with antibodies will be higher in those patients with a viral infection at the onset of their illness than in those patients with other or undefined illness onsets.

Conditions

Postural Orthostatic Tachycardia Syndrome

Keywords

Postural orthostatic syndrome; orthostatic intolerance; autonomic dysfunction

Outcome Measures

Primary Outcomes (1)

• Ab titer in POTS patients compared to control subjects

  The primary outcome measure will be the proportion of subjects with alpha-1 Ab titer. The primary comparison will be the proportion of Ab titers between POTS patients compared to control subjects.

  One time only, at first visit

Secondary Outcomes (5)

• comparison of the number of POTS patients with viral based Ab versus non-viral based Ab

  One time only - at first study visit

• comparison of the number of POTS patients with and without Ehlers Danlos syndrome III

  One time only - at first study visit

• comparison of the number of POTS patients with a history of autoimmune disorders versus no history of auto-immune disorders

  One time only - at first study visit

• comparison of the number of POTS patients with fatigue versus no history of fatigue based on severity of impact on normal daily activities.

  One time only - at first study visit

• comparison of pain in POTS patients versus non-POTS patients

  One time only - at first study visit

Study Arms (2)

orthostatic tachycardia syndrome

participants with postural orthostatic tachycardia syndrome

Other: History; Other: Physical; Other: blood draw; Behavioral: Questionnaires

control subjects

participants not diagnosed with postural orthostatic tachycardia syndrome

Other: History; Other: Physical; Other: blood draw; Behavioral: Questionnaires

Interventions

History OTHER

the physician / PI will conduct a history that may include: demographics Framingham risk factors metabolic diseases inflammatory diseases autoimmune disorders review of medications date of last menstrual period (females) family history of autonomic disorders Onset of postural orthostatic tachycardia syndrome

control subjects; orthostatic tachycardia syndrome

Physical OTHER

the physical exam will include: height weight orthostatic vitals (heart rate and blood pressure), supine and standing for up to 10 minutes. Beighton Criteria for Join Hypermobility Syndrome Dependent acrocyanosis

control subjects; orthostatic tachycardia syndrome

blood draw OTHER

blood will be drawn for: antibodies regulating cardiovascular function inflammatory markers no more than 15 ml (1 TBSP) will be drawn.

control subjects; orthostatic tachycardia syndrome

Questionnaires BEHAVIORAL

The questionnaires will be completed directly online (web-based interface) using a personalized link that will be provided to the subjects after they give their informed consent. These will be created in a REDCap-Survey environment, with the data collected and stored on a password-protected, HIPAA-compliant, secure computer server. The following questionnaires will be conducted: RAND-36 Health Thermometer Chalder Fatigue Scale Daily diary of Fatigue Symptoms - Fibromyalgia Pain Detect Questionnaire Orthostatic Grading Scale COMPASS-31

control subjects; orthostatic tachycardia syndrome

Eligibility Criteria

• Age: 13 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic orthostatic intolerance, sometimes known as the postural tachycardia syndrome (POTS), is the most common disorder among patients seen at several centers specializing in diseases of the autonomic nervous system. excessive increase in heart rate \[\>30 min-1\] on standing associated with orthostatic symptoms \[including palpitation, chest pain syndrome, dyspnea on standing, mental clouding and difficulties with concentration\], in the absence of orthostatic hypotension. Orthostatic tachycardia can produce substantial disability among otherwise healthy people. Patients typically feel tired and run down. Many also report a myriad of symptoms that are hard to categorize, often involving fatigue. We and others have reported that patients had a diminished quality of life.

You may qualify if:

• Postural Tachycardia Syndrome
• Previously diagnosed with POTS
• Control Subjects
• Not diagnosed with POTS
• Age between 13-80 years
• Male and female subjects are eligible.
• Able and willing to provide informed consent

You may not qualify if:

• Inability to give, or withdrawal of, informed consent
• Other factors which in the investigator's opinion would prevent the subject from completing the protocol.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be drawn for future assay and analysis of the following tests: Antibodies regulating cardiovascular function The clinical significance of these antibodies is unknown. We will share the results of the antibody panel with the subject, but with the caveat that no clinical interpretation or comment on significance can be made. Inflammatory markers

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance; Primary Dysautonomias

Interventions

Health Records, Personal; Restraint, Physical; Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Behavior Control; Therapeutics; Immobilization; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Satish Raj, MD, MSCI

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor of Medicine and Pharmacology

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2014
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

US (1)