Postural Orthostatic Tachycardia SyndromeNCT05923840
Chemoreflex and Baroreflex Alterations Causing Postural Tachycardia Syndrome With Orthostatic Hyperpnea and Hypocapnia
A study testing Chemoreflex Testing, Baroreflex testing and Orthostatic stress testing in people with Postural Orthostatic Tachycardia Syndrome and Hypocapnia, run by New York Medical College at 1 site in United States.
Trial summary
Postural tachycardia syndrome (POTS) is the most common chronic cause of postural lightheadedness, and upright confusion afflicting many Americans, mostly young women. Many POTS patients hyperventilate by increasing their depth of breathing that produces tachycardia, alters blood flow and blood pooling in the body and… Read more about this study
- Who is it for?
- Ages 15 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome, Hypocapnia, Hyperventilation
- What is being tested?
- Chemoreflex Testing, Baroreflex testing and Orthostatic stress testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 39 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The investigators will recruit female POTS cases (N=80) and healthy female control subjects (N=40) aged 15-39 years, matched for BMI. POTS is a disease in which 80-90% are females. Therefore, the investigators will only recruit female POTS patients and controls.
Who cannot join
- Any subjects with systemic disease or who cannot stop taking prescribed medications for at least 2 weeks prior to study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NewYork Medical College
Hawthorne, New York, 10532
Marvin S Medow, Ph.D., 914-594-2848, marvin_medow@nymc.edu
Julian M Stewart, M.D.,Ph.D., 914-594=2849, julian_stweart@nymc.edu
About this study
Official title: Mechanism of Chemoreflex and Baroreflex Alterations Causing Postural Tachycardia Syndrome in POTS Patients With Orthostatic Hyperpnea and Hypocapnia
Postural tachycardia syndrome (POTS) is the most common chronic cause of postural lightheadedness, and upright confusion afflicting many Americans, mostly young women. Many POTS patients hyperventilate by increasing their depth of breathing that produces tachycardia, alters blood flow and blood pooling in the body and importantly reduces brain blood flow causing "brain fog". In this proposal the investigators will demonstrate in young women that abnormal repeated brief impairment of blood pressure and brain flow just after standing sensitizes the body's oxygen sensor in POTS to respond as if it were in a low oxygen environment causing hyperventilation and its consequences. In this project the investigators will use various drugs that will help to understand the mechanisms that cause POTS in this unique subset of POTS patients who hyperventilate.
Read the detailed description
The Investigators will compare results from female POTS patients, free of known pulmonary or sleep disorders aged 15 to 39 years with, and without orthostatic hyperpneic hypocapnia, to healthy female volunteers with the following two (2) specific aims:
- To test poikilocapnic (allowing carbon dioxide (CO2) to vary) orthostatic cardiorespiratory responses to determine whether prolonged initial orthostatic hypotension (IOH) precedes upright hypocapnia in hyperpneic POTS but not in controls or non-hyperpneic POTS. Subjects are instrumented for cerebral blood flow, respiratory and hemodynamic measurements, investigating splanchnic blood flow by indocyanine green infusion, and measuring changes of CBV, regional blood volumes, and cardiac output (CO) by impedance plethysmography during a 10 min stand to quantify IOH, and a 10 min tilt test to 70⁰ to quantitate cardiorespiratory changes. These changes during tilt stratify hyperpneic and non-hyperpneic POTS.
- To test if chemoreflex sensitization of ventilation and sympathetic activity (by microneurography) are abnormal when supine and tilted upright at 45o and how that interacts with Oxford measured cardiovagal and sympathetic baroreflexes under controlled gas conditions which are: isocapnic hypoxia and isocapnic hyperoxia to measure carotid body reflex; hyperoxic isocapnia and hyperoxic hypercapnia to measure central chemoreflexes. Hyperoxia silences peripheral chemoreceptors and will normalize baroreflex and tilt responses.
- Being tested
- Chemoreflex Testing, Baroreflex testing, Orthostatic stress testing
- Keywords
- Postural Tachycardia Syndrome (POTS), Young Females, Tilt Table Testing, Initial Orthostatic Intolerance
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Hypocapnia, Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemoreflex TestingDiagnostic test
The carotid body chemoreflex can be tested by holding carbon dioxide (CO2) constant (isocapnic) and applying hypoxia and hyperoxia. Measurements are then made of expiratory minute volume and of sympathetic activity. The central chemoreflex measures isocapnic and hypercapnic responses in the presence of hyperoxia to suppress the carotid body chemoreflex.
Baroreflex testingDiagnostic test
Baroreceptors are measured by the change of heart rate (HR) and sympathetic activity with changing blood pressure using the modified Oxford technique. Blood pressure is lowered an amount by a bolus of sodium nitroprusside and then raised by a bolus of phenylephrine. When standing baroreflexes are activated and the investigators will measure chemoreflex activity upright to see how baroreflex effects the chemoreflexes. Similarly chemoreflexes affect the baroreflexes best observed when the patients are supine.
Orthostatic stress testingDiagnostic test
Orthostatic Stress tests are administered in two forms: a standing test to evoke the initial orthostatic hypotensive response that sensitizes and triggers the carotid body chemoreflex by intermittent stagnant ischemia. And the 70 degree upright tilt test that best identifies causal changes in regional blood volumes and flows and in respiratory patterns of hyperpneic hypocapnia.
| Study group | Role | What they receive |
|---|---|---|
| Female Postural Tachycardia Syndrome (POTS) patients without orthostatic hyperpneic hypocapnia | Active comparator | Female POTS patients without orthostatic hyperpneic hypocapnia identified by tilt table testing and respiratory monitoring. Receives: Diagnostic Test: Chemoreflex Testing; Diagnostic Test: Baroreflex testing; Diagnostic Test: Orthostatic stress testing |
| Female POTS patients with orthostatic hyperpneic hypocapnia | Active comparator | Female POTS patients without orthostatic hyperpneic hypocapnia identified by tilt table testing and respiratory monitoring. Receives: Diagnostic Test: Chemoreflex Testing; Diagnostic Test: Baroreflex testing; Diagnostic Test: Orthostatic stress testing |
| Healthy Female vounteers | Active comparator | Healthy Female vounteers Receives: Diagnostic Test: Chemoreflex Testing; Diagnostic Test: Baroreflex testing; Diagnostic Test: Orthostatic stress testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthostatic tachycardia
Heart rate (beats per minute) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.
Measured: Baseline in all subjects
Orthostatic Blood Pressure Changes
Blood pressure (mmHg) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.
Measured: Baseline in all subjects
Orthostatic Changes in Systemic Vascular Resistance
Systemic vascular resistance (mmHg⋅min⋅mL-1) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.
Measured: Baseline in all subjects
Orthostatic Blood Volume Changes
Central Blood Volume in liters (L) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.
Measured: Baseline in all subjects
Orthostatic Changes in Segmental Blood Flow
Segmental Blood Flows (ml•min-1•100 ml tissue-1) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.
Measured: Baseline in all subjects
Orthostatic Changes in Cerebral Blood Flow
Cerebral Blood Flow (cm/s) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.
Measured: Baseline in all subjects
Orthostasis Induced Rate of Breathing
Changes in the rate of breathing (breaths per minute) will be determined in all subjects before and after being tilted upright on a tilt table.
Measured: Baseline in all subjects
Orthostasis Induced Depth of Breathing
Changes in the depth of breathing (L of inhaled air per minute) will be determined in all subjects before and after being tilted upright on a tilt table.
Measured: Baseline in all subjects
Measurement of chemoreflex sensitivity carotid body chemoreflex and central chemoreflex
Paired hypoxia and isocapnic hyperoxia determine the carotid body chemoreflex sensitivity; measurements of ventilation and sympathetic activation using Muscle Sympathetic Nerve Activity (MSNA - mean burst frequency and normalized mean burst area and expressed as arbitrary units (AU) per minute) define the responses. Similarly, measurement of during isocapnic hyperoxia and hypercapnic hyperoxia determine central chemoreflex stressors - measure sympathetic activity as responses.
Measured: Baseline in all subjects
Effects of chemoreflex activation on baroreflexfunction and the effects of baroreflex on chemoreflex sensitivity
Supine chemoreflex activation using controlled gas conditions which are: isocapnic hypoxia and isocapnic hyperoxia to measure carotid body reflex; hyperoxic isocapnia and hyperoxic hypercapnia to measure central chemoreflexes. Hyperoxia silences peripheral chemoreceptors and will normalize baroreflex and tilt responses) should alter baroreflex function measured as the change in RR Interval (reciprocal of heart rate) in milliseconds per millimeter of mercury change in systolic blood pressure). This will be performed both supine and during 45 degree tilting which will activate the baroreflexes and reduce chemoreflex responses.
Measured: Baseline in all subjects
Secondary outcomes (2)
Systemic changes in leg blood volumes during orthostatic testing.
The investigators will measure changes in leg blood volume using impedance plethysmography methods which measures changes in electrical resistance (in Ohms) of the legs before and after tilt table testing which is expressed as ml•min-1•100 ml tissue-1.
Measured: Baseline in all subjects
Systemic changes in abdominal blood volumes during orthostatic testing.
The investigators will measure changes in abdominal blood volume using impedance plethysmography methods which measures changes in electrical resistance (in Ohms) of the abdomin before and after tilt table testing which is expressed as ml•min-1•100 ml tissue-1.
Measured: Baseline in all subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start23 Sep 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2024 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will compare results from female POTS patients, free of known pulmonary or sleep disorders aged 15 to 39 years with, and without orthostatic hyperpneic hypocapnia, to healthy female volunteers.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marvin Medow, New York Medical College
- Investigators
- Marvin S Medow, Ph.D., Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923840
- Sponsor's protocol ID
- R56HL162752
- Status last verified
- Jun 2023
- First submitted
- 31 May 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Chemoreflex and Baroreflex Alterations Causing Postural Tachycardia Syndrome in POTS Patients With Orthostatic Hyperpnea and Hypocapnia
- ClinicalTrials.gov ID
- NCT05923840
- Acronym / sponsor ID
- R56HL162752
- Keywords
- Postural Tachycardia Syndrome (POTS), Young Females, Tilt Table Testing, Initial Orthostatic Intolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 28 Jun 2023 (actual)
- 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.
Postural tachycardia syndrome (POTS) is the most common chronic cause of postural lightheadedness, and upright confusion afflicting many Americans, mostly young women. Many POTS patients hyperventilate by increasing their depth of breathing that produces tachycardia, alters blood flow and blood pooling in the body and importantly reduces brain blood flow causing "brain fog". In this proposal the investigators will demonstrate in young women that abnormal repeated brief impairment of blood pressure and brain flow just after standing sensitizes the body's oxygen sensor in POTS to respond as if it were in a low oxygen environment causing hyperventilation and its consequences. In this project the investigators will use various drugs that will help to understand the mechanisms that cause POTS in this unique subset of POTS patients who hyperventilate.
Detailed description
The Investigators will compare results from female POTS patients, free of known pulmonary or sleep disorders aged 15 to 39 years with, and without orthostatic hyperpneic hypocapnia, to healthy female volunteers with the following two (2) specific aims:
- To test poikilocapnic (allowing carbon dioxide (CO2) to vary) orthostatic cardiorespiratory responses to determine whether prolonged initial orthostatic hypotension (IOH) precedes upright hypocapnia in hyperpneic POTS but not in controls or non-hyperpneic POTS. Subjects are instrumented for cerebral blood flow, respiratory and hemodynamic measurements, investigating splanchnic blood flow by indocyanine green infusion, and measuring changes of CBV, regional blood volumes, and cardiac output (CO) by impedance plethysmography during a 10 min stand to quantify IOH, and a 10 min tilt test to 70⁰ to quantitate cardiorespiratory changes. These changes during tilt stratify hyperpneic and non-hyperpneic POTS.
- To test if chemoreflex sensitization of ventilation and sympathetic activity (by microneurography) are abnormal when supine and tilted upright at 45o and how that interacts with Oxford measured cardiovagal and sympathetic baroreflexes under controlled gas conditions which are: isocapnic hypoxia and isocapnic hyperoxia to measure carotid body reflex; hyperoxic isocapnia and hyperoxic hypercapnia to measure central chemoreflexes. Hyperoxia silences peripheral chemoreceptors and will normalize baroreflex and tilt responses.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The investigators will compare results from female POTS patients, free of known pulmonary or sleep disorders aged 15 to 39 years with, and without orthostatic hyperpneic hypocapnia, to healthy female volunteers.
| Arm | Type | Receives |
|---|---|---|
| Female Postural Tachycardia Syndrome (POTS) patients without orthostatic hyperpneic hypocapnia | Active comparator | Diagnostic Test: Chemoreflex Testing, Diagnostic Test: Baroreflex testing, Diagnostic Test: Orthostatic stress testingFemale POTS patients without orthostatic hyperpneic hypocapnia identified by tilt table testing and respiratory monitoring. |
| Female POTS patients with orthostatic hyperpneic hypocapnia | Active comparator | Diagnostic Test: Chemoreflex Testing, Diagnostic Test: Baroreflex testing, Diagnostic Test: Orthostatic stress testingFemale POTS patients without orthostatic hyperpneic hypocapnia identified by tilt table testing and respiratory monitoring. |
| Healthy Female vounteers | Active comparator | Diagnostic Test: Chemoreflex Testing, Diagnostic Test: Baroreflex testing, Diagnostic Test: Orthostatic stress testingHealthy Female vounteers |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The investigators will recruit female POTS cases (N=80) and healthy female control subjects (N=40) aged 15-39 years, matched for BMI. POTS is a disease in which 80-90% are females. Therefore, the investigators will only recruit female POTS patients and controls.
Key exclusion criteria (1 listed)
- Any subjects with systemic disease or who cannot stop taking prescribed medications for at least 2 weeks prior to study.
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 |
|---|---|---|
| Chemoreflex TestingThe carotid body chemoreflex can be tested by holding carbon dioxide (CO2) constant (isocapnic) and applying hypoxia and hyperoxia. Measurements are then made of expiratory minute volume and of sympathetic activity. The central chemoreflex measures isocapnic and hypercapnic responses in the presence of hyperoxia to suppress the carotid body chemoreflex. | Diagnostic test | Female POTS patients with orthostatic hyperpneic hypocapnia, Female Postural Tachycardia Syndrome (POTS) patients without orthostatic hyperpneic hypocapnia, Healthy Female vounteers |
| Baroreflex testingBaroreceptors are measured by the change of heart rate (HR) and sympathetic activity with changing blood pressure using the modified Oxford technique. Blood pressure is lowered an amount by a bolus of sodium nitroprusside and then raised by a bolus of phenylephrine. When standing baroreflexes are activated and the investigators will measure chemoreflex activity upright to see how baroreflex effects the chemoreflexes. Similarly chemoreflexes affect the baroreflexes best observed when the patients are supine. | Diagnostic test | Female POTS patients with orthostatic hyperpneic hypocapnia, Female Postural Tachycardia Syndrome (POTS) patients without orthostatic hyperpneic hypocapnia, Healthy Female vounteers |
| Orthostatic stress testingOrthostatic Stress tests are administered in two forms: a standing test to evoke the initial orthostatic hypotensive response that sensitizes and triggers the carotid body chemoreflex by intermittent stagnant ischemia. And the 70 degree upright tilt test that best identifies causal changes in regional blood volumes and flows and in respiratory patterns of hyperpneic hypocapnia. | Diagnostic test | Female POTS patients with orthostatic hyperpneic hypocapnia, Female Postural Tachycardia Syndrome (POTS) patients without orthostatic hyperpneic hypocapnia, Healthy Female vounteers |
Primary outcome
Orthostatic tachycardia
Time frame: Baseline in all subjects
Heart rate (beats per minute) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.
Orthostatic Blood Pressure Changes
Time frame: Baseline in all subjects
Blood pressure (mmHg) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.
Orthostatic Changes in Systemic Vascular Resistance
Time frame: Baseline in all subjects
Systemic vascular resistance (mmHg⋅min⋅mL-1) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.
Orthostatic Blood Volume Changes
Time frame: Baseline in all subjects
Central Blood Volume in liters (L) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.
Orthostatic Changes in Segmental Blood Flow
Time frame: Baseline in all subjects
Segmental Blood Flows (ml•min-1•100 ml tissue-1) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.
Orthostatic Changes in Cerebral Blood Flow
Time frame: Baseline in all subjects
Cerebral Blood Flow (cm/s) delimit the orthostatic response. Two separate orthostatic tests are used: a standing test and a 70 degree upright tilt test. The standing test will delineate the carotid blood flow signal that sensitizes the carotid body chemoreflex. The tilt test will delineate the effects of sustained tachyardia (and hyperpnea) on systemic hemodynamics and breathing.
Orthostasis Induced Rate of Breathing
Time frame: Baseline in all subjects
Changes in the rate of breathing (breaths per minute) will be determined in all subjects before and after being tilted upright on a tilt table.
Orthostasis Induced Depth of Breathing
Time frame: Baseline in all subjects
Changes in the depth of breathing (L of inhaled air per minute) will be determined in all subjects before and after being tilted upright on a tilt table.
Measurement of chemoreflex sensitivity carotid body chemoreflex and central chemoreflex
Time frame: Baseline in all subjects
Paired hypoxia and isocapnic hyperoxia determine the carotid body chemoreflex sensitivity; measurements of ventilation and sympathetic activation using Muscle Sympathetic Nerve Activity (MSNA - mean burst frequency and normalized mean burst area and expressed as arbitrary units (AU) per minute) define the responses. Similarly, measurement of during isocapnic hyperoxia and hypercapnic hyperoxia determine central chemoreflex stressors - measure sympathetic activity as responses.
Effects of chemoreflex activation on baroreflexfunction and the effects of baroreflex on chemoreflex sensitivity
Time frame: Baseline in all subjects
Supine chemoreflex activation using controlled gas conditions which are: isocapnic hypoxia and isocapnic hyperoxia to measure carotid body reflex; hyperoxic isocapnia and hyperoxic hypercapnia to measure central chemoreflexes. Hyperoxia silences peripheral chemoreceptors and will normalize baroreflex and tilt responses) should alter baroreflex function measured as the change in RR Interval (reciprocal of heart rate) in milliseconds per millimeter of mercury change in systolic blood pressure). This will be performed both supine and during 45 degree tilting which will activate the baroreflexes and reduce chemoreflex responses.
2 secondary outcomes
Systemic changes in leg blood volumes during orthostatic testing.
Time frame: Baseline in all subjects
Systemic changes in abdominal blood volumes during orthostatic testing.
Time frame: Baseline in all subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
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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.
Marvin S Medow, Ph.D. principal investigator
New York Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemoreflex Testing, Baroreflex testing and Orthostatic stress testing in people with Postural Orthostatic Tachycardia Syndrome and Hypocapnia, run by New York Medical College 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marvin S Medow, Ph.D. (914-594-2848, marvin_medow@nymc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthostatic tachycardia (time frame: Baseline in all subjects). The study lists 10 primary outcomes in all. 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 28 Jun 2023.