Postural Orthostatic Tachycardia SyndromeNCT02196376
Assessment of Antibodies and Inflammatory Markers in Postural Tachycardia Syndrome
An observational study of Postural Orthostatic Tachycardia Syndrome, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- History, Physical and blood draw
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Inability to give, or withdrawal of, informed consent
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the 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
- 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.
- Being tested
- History, Physical, blood draw, Questionnaires
- Keywords
- Postural orthostatic syndrome, orthostatic intolerance, autonomic dysfunction
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistoryOther
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
PhysicalOther
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 drawOther
blood will be drawn for: antibodies regulating cardiovascular function inflammatory markers
no more than 15 ml (1 TBSP) will be drawn.
QuestionnairesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| orthostatic tachycardia syndrome | participants with postural orthostatic tachycardia syndrome Receives: Other: History; Other: Physical; Other: blood draw; Behavioral: Questionnaires | |
| control subjects | participants not diagnosed with postural orthostatic tachycardia syndrome Receives: Other: History; Other: Physical; Other: blood draw; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Blood samples will be collected at study visit.
Measured: One time only - at first study visit
comparison of the number of POTS patients with and without Ehlers Danlos syndrome III
Ehlers Danlos Syndrome will be assessed during the physical exam. The hypermobility assessment (Beighton Score) will be used.
Measured: 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
History of auto-immune disorders will be collected during the history and physical performed by the physician.
Measured: 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.
Fatigue will be assessed using the RAND-36 Health Thermometer Chalder Scale of Fatigue, and Daily Diary of Fatigue.
Measured: One time only - at first study visit
comparison of pain in POTS patients versus non-POTS patients
Pain will be assessed using Fibromyalgia Pain Detect Questionnaire, Orthostatic Grading Scale and COMPASS-31.
Measured: One time only - at first study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Orthostatic Tachycardia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satish R. Raj, Vanderbilt University
- Investigators
- Satish Raj, MD, MSCI, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196376
- Sponsor's protocol ID
- 140671
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2014
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Antibodies and Inflammatory Markers in Postural Tachycardia Syndrome
- ClinicalTrials.gov ID
- NCT02196376
- Acronym / sponsor ID
- 140671
- Keywords
- Postural orthostatic syndrome, orthostatic intolerance, autonomic dysfunction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| orthostatic tachycardia syndrome | – | Other: History, Other: Physical, Other: blood draw, Behavioral: Questionnairesparticipants with postural orthostatic tachycardia syndrome |
| control subjects | – | Other: History, Other: Physical, Other: blood draw, Behavioral: Questionnairesparticipants not diagnosed with postural orthostatic tachycardia syndrome |
Who may qualify
- Ages
- 13 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Postural Tachycardia Syndrome
- Previously diagnosed with POTS
- Control Subjects
- Not diagnosed with POTS
- Age between 13-80 years
Key exclusion criteria (2 listed)
- Inability to give, or withdrawal of, informed consent
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Historythe 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 | control subjects, orthostatic tachycardia syndrome |
| Physicalthe 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 | control subjects, orthostatic tachycardia syndrome |
| blood drawblood will be drawn for: antibodies regulating cardiovascular function inflammatory markers no more than 15 ml (1 TBSP) will be drawn. | Other | control subjects, orthostatic tachycardia syndrome |
| QuestionnairesThe 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 | Behavioural | control subjects, orthostatic tachycardia syndrome |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satish Raj, MD, MSCI principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postural Orthostatic Tachycardia Syndrome, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ab titer in POTS patients compared to control subjects (time frame: One time only, at first visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.