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Trial record 3 of 64 for:    Postural Tachycardia Syndrome

Assessment of Antibodies and Inflammatory Markers in Postural Tachycardia Syndrome

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ClinicalTrials.gov Identifier: NCT02196376
Recruitment Status : Active, not recruiting
First Posted : July 22, 2014
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University

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.

Condition or disease Intervention/treatment
Postural Orthostatic Tachycardia Syndrome Other: History Other: Physical Other: blood draw Behavioral: Questionnaires

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 212 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Antibodies and Inflammatory Markers in Postural Tachycardia Syndrome
Study Start Date : July 2014
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
orthostatic tachycardia syndrome
participants with postural orthostatic tachycardia syndrome
Other: 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

Other: 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


Other: blood draw

blood will be drawn for: antibodies regulating cardiovascular function inflammatory markers

no more than 15 ml (1 TBSP) will be drawn.


Behavioral: 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


control subjects
participants not diagnosed with postural orthostatic tachycardia syndrome
Other: 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

Other: 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


Other: blood draw

blood will be drawn for: antibodies regulating cardiovascular function inflammatory markers

no more than 15 ml (1 TBSP) will be drawn.


Behavioral: 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 Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
    Blood samples will be collected at study visit.

  2. comparison of the number of POTS patients with and without Ehlers Danlos syndrome III [ Time Frame: One time only - at first study visit ]
    Ehlers Danlos Syndrome will be assessed during the physical exam. The hypermobility assessment (Beighton Score) will be used.

  3. 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 ]
    History of auto-immune disorders will be collected during the history and physical performed by the physician.

  4. 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 ]
    Fatigue will be assessed using the RAND-36 Health Thermometer Chalder Scale of Fatigue, and Daily Diary of Fatigue.

  5. comparison of pain in POTS patients versus non-POTS patients [ Time Frame: One time only - at first study visit ]
    Pain will be assessed using Fibromyalgia Pain Detect Questionnaire, Orthostatic Grading Scale and COMPASS-31.


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



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Ages Eligible for Study:   13 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196376


Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Satish Raj, MD, MSCI Vanderbilt University

Responsible Party: Satish R. Raj, Adjunct Associate Professor of Medicine and Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02196376     History of Changes
Other Study ID Numbers: 140671
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

Keywords provided by Satish R. Raj, Vanderbilt University:
Postural orthostatic syndrome
orthostatic intolerance
autonomic dysfunction

Additional relevant MeSH terms:
Syndrome
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs