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Clinical Trials/NCT02196376
NCT02196376
Active, not recruiting
Not Applicable

Assessment of Antibodies and Inflammatory Markers in Postural Tachycardia Syndrome

Vanderbilt University1 site in 1 country212 target enrollmentJuly 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postural Orthostatic Tachycardia Syndrome
Sponsor
Vanderbilt University
Enrollment
212
Locations
1
Primary Endpoint
Ab titer in POTS patients compared to control subjects
Status
Active, not recruiting
Last Updated
6 months ago

Overview

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.

Detailed Description

Postural orthostatic tachycardia syndrome is poorly understood. Many of these patients have elevated levels of plasma norepinephrine, particularly when upright One subgroup of patients has a primary hyperadrenergic state. The majority of patients have a marked deficit in plasma blood volume compared to healthy control subjects. The investigators have previously reported that some patients suffer paradoxically from a partial dysautonomia affecting the lower limbs. Most patients seem to suffer from either a primary or secondary increase in central sympathetic nervous system drive. Recent data have shown that patients with postural orthostatic tachycardia syndrome have a lower cardiac stroke volume than their healthy counterparts and this low stroke volume may drive their orthostatic tachycardia. The investigators plan to do the following: The physical examination will include (at minimum): * Height * Weight * Orthostatic vital signs (heart rate and blood pressure) Supine and Standing for up to 10 minutes * Beighton Criteria for Joint Hypermobility Syndrome (Ehlers-Danlos III) * Dependent acrocyanosis (during stand test) Continuous Heart Rate and Blood Pressure Recording A subset of subjects will be given the opportunity to also have continuous recordings of heart rate and blood pressure for 5-10 minutes while lying down quietly. They will be instrumented with EKG patches on their body and a finger blood pressure cuff, and these data will be digitally sampled and acquired on a dedicated laptop computer for later offline analysis. There will be an optional rider on the consent form to allow the patient to consent to this portion of the study. Blood work Blood will be drawn for future assay and analysis of the following tests: * Antibodies regulating cardiovascular function o The clinical significance of these antibodies is unknown. The investigators 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 The total amount of blood drawn for this project will be less than 15 ml. Questionnaires * RAND-36 * Health Thermometer * Chandler Fatigue Scale * Daily diary of Fatigue Symptoms - Fibromyalgia * Pain Detect Questionnaire * Orthostatic Grading Scale * COMPASS-31 * Structured History (including some of the elements from section 6.1) These 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.

Registry
clinicaltrials.gov
Start Date
July 1, 2014
End Date
July 1, 2029
Last Updated
6 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Satish R. Raj

Adjunct Associate Professor of Medicine and Pharmacology

Vanderbilt University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Ab titer in POTS patients compared to control subjects

Time Frame: One time only, at first visit

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.

Secondary Outcomes

  • 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 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 pain in POTS patients versus non-POTS patients(One time only - at first study visit)
  • comparison of the number of POTS patients with viral based Ab versus non-viral based Ab(One time only - at first study visit)

Study Sites (1)

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