Overview

This trial is active, not recruiting.

Condition postural orthostatic tachycardia syndrome
Treatments history, physical, blood draw, questionnaires
Sponsor Vanderbilt University
Start date July 2014
End date July 2018
Trial size 212 participants
Trial identifier NCT02196376, 140671

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
participants with postural orthostatic tachycardia syndrome
history
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
physical
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
blood draw
blood will be drawn for: antibodies regulating cardiovascular function inflammatory markers no more than 15 ml (1 TBSP) will be drawn.
questionnaires
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
participants not diagnosed with postural orthostatic tachycardia syndrome
history
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
physical
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
blood draw
blood will be drawn for: antibodies regulating cardiovascular function inflammatory markers no more than 15 ml (1 TBSP) will be drawn.
questionnaires
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

Primary Outcomes

Measure
Ab titer in POTS patients compared to control subjects
time frame: One time only, at first visit

Secondary Outcomes

Measure
comparison of the number of POTS patients with viral based Ab versus non-viral based Ab
time frame: One time only - at first study visit
comparison of the number of POTS patients with and without Ehlers Danlos syndrome III
time frame: 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
time frame: 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.
time frame: One time only - at first study visit
comparison of pain in POTS patients versus non-POTS patients
time frame: One time only - at first study visit

Eligibility Criteria

Male or female participants from 13 years up to 80 years old.

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.

Additional Information

Official title Assessment of Antibodies and Inflammatory Markers in Postural Tachycardia Syndrome
Principal investigator Satish Raj, MD, MSCI
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.