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RecruitingNCT05923840Updated Jun 28, 2023

Chemoreflex and Baroreflex Alterations Causing Postural Tachycardia Syndrome With Orthostatic Hyperpnea and Hypocapnia

An interventional study of Chemoreflex Testing and Baroreflex testing in Postural Orthostatic Tachycardia Syndrome, Hypocapnia and Hyperventilation, sponsored by New York Medical College. Recruiting at 1 site in United States. Open to female participants aged 15 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-28.

Sponsored by New York Medical College · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
15 Years to 39 Years
Sex
Female
01

Study 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 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:

  1. 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.
  2. 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.
02

Conditions studied

  • Postural Orthostatic Tachycardia Syndrome
  • Hypocapnia
  • Hyperventilation

Keywords

  • Postural Tachycardia Syndrome (POTS)
  • Young Females
  • Tilt Table Testing
  • Initial Orthostatic Intolerance
03

Who can participate

Ages eligible
15 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Any subjects with systemic disease or who cannot stop taking prescribed medications for at least 2 weeks prior to study.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Female Postural Tachycardia Syndrome (POTS) patients without orthostatic hyperpneic hypocapnia

    Female POTS patients without orthostatic hyperpneic hypocapnia identified by tilt table testing and respiratory monitoring.

    Diagnostic Test: Chemoreflex Testing · Diagnostic Test: Baroreflex testing · Diagnostic Test: Orthostatic stress testing

  • Active comparator
    Female POTS patients with orthostatic hyperpneic hypocapnia

    Female POTS patients without orthostatic hyperpneic hypocapnia identified by tilt table testing and respiratory monitoring.

    Diagnostic Test: Chemoreflex Testing · Diagnostic Test: Baroreflex testing · Diagnostic Test: Orthostatic stress testing

  • Active comparator
    Healthy Female vounteers

    Healthy Female vounteers

    Diagnostic Test: Chemoreflex Testing · Diagnostic Test: Baroreflex testing · Diagnostic Test: Orthostatic stress testing

Interventions

  • Diagnostic testChemoreflex Testing

    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.

  • Diagnostic testBaroreflex testing

    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.

  • Diagnostic testOrthostatic stress testing

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline in all subjects

  2. 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.

    Time frame: Baseline in all subjects

  3. 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.

    Time frame: Baseline in all subjects

  4. 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.

    Time frame: Baseline in all subjects

  5. 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.

    Time frame: Baseline in all subjects

  6. 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.

    Time frame: Baseline in all subjects

  7. 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.

    Time frame: Baseline in all subjects

  8. 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.

    Time frame: Baseline in all subjects

  9. 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.

    Time frame: Baseline in all subjects

  10. 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.

    Time frame: Baseline in all subjects

Secondary outcomes

  1. 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.

    Time frame: Baseline in all subjects

  2. 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.

    Time frame: Baseline in all subjects

06

Study locations

1 of 1 sites recruiting
  • NewYork Medical College
    Hawthorne, New York 10532, United States
    • Marvin S Medow, Ph.D. · Contact · marvin_medow@nymc.edu · 914-594-2848
    • Julian M Stewart, M.D.,Ph.D. · Contact · julian_stweart@nymc.edu · 914-594=2849
    • Marvin S. Medow, Ph.D. · Principal investigator
    • Julian M. Stewart, M.D., Ph.D. · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT05923840
Lead sponsor
New York Medical College
Responsible party
Marvin Medow (Professor of Pediatrics, New York Medical College) — Principal investigator
First posted
Jun 28, 2023
Start date
Sep 23, 2022
Primary completion
Aug 31, 2023 (estimated)
Completion
Aug 31, 2024 (estimated)
Last update
Jun 28, 2023

Study contacts

Marvin S Medow, Ph.D.
Contact
marvin_medow@nymc.edu
914-594-2848
Julian M Stewart, M.D., Ph.D.
Contact
julian_stewart@nymc.edu
914-594-2849
Marvin S Medow, Ph.D.
principal investigator · New York Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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