Postural Orthostatic Tachycardia SyndromeNCT01563107
Dietary Sodium's Effect on Urinary Sodium and Dopamine Excretion in Patients With Postural Tachycardia Syndrome
A study testing Plasma Volume, Exercise Capacity Test - Bicycle and Posture Study in people with Postural Orthostatic Tachycardia Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Patients with Postural Tachycardia Syndrome (POTS) may not adequately expand their plasma volume in response to a high sodium diet. Mechanisms involved in the regulation of plasma volume, such as the renin-angiotensin-aldosterone system and renal dopamine (DA), may be impaired in POTS and may respond inappropriately… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- Plasma Volume, Exercise Capacity Test - Bicycle and Posture Study
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal patients with POTS and healthy volunteers, 18-50 years old, who are non-smokers and free of medications with the potential to influence blood pressure
- Patients diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
- Patients who Increase heart rate ≥30 beats/min with position change from supine to standing (10 minutes)
- For patients, chronic symptoms consistent with POTS that are worse when upright and get better with recumbence
- Only female participants are eligible. Since 80-90% of POTS patients are female, and there can be differences in measures with the menstrual cycle, including a small number of males might introduce a significant amount of noise.
- Able and willing to provide informed consent
Who cannot join
- Smokers
- Overt cause for postural tachycardia, i.e., acute dehydration
- Significant cardiovascular, pulmonary, hepatic, or hematological disease by history or screening results
- Positive pregnancy test or breastfeeding
- Hypertension defined as BP>145/95 off medications when supine or needing antihypertensive medication
- Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Patients with Postural Tachycardia Syndrome (POTS) may not adequately expand their plasma volume in response to a high sodium diet. Mechanisms involved in the regulation of plasma volume, such as the renin-angiotensin-aldosterone system and renal dopamine (DA), may be impaired in POTS and may respond inappropriately to changes in dietary sodium. The investigators propose that the changes in urinary sodium and dopamine excretion caused by consuming low-sodium and high-sodium diets will be different between patients with POTS and healthy volunteers. The purpose of this study is to determine (1) whether changes in dietary sodium level appropriately influence sodium excretion in POTS; (2) whether changes in dietary sodium level appropriately influence DA excretion in POTS; (3) whether a high dietary sodium level appropriately expands plasma volume in POTS; and (4) whether patients with POTS have improvements in their orthostatic tachycardia and symptoms as a result of a high dietary sodium level.
Read the detailed description
Study Day 1
- Start 150 mEq Na+/day diet (POTS patients as inpatients; healthy control subjects with Clinical Research Center(CRC)- provided outpatient diet); consume 1.5-2 liters of water per day
- Start a 24hour (24hr) urine collection (for sodium (Na+), potassium (K+), creatinine (Cr), fractionated catecholamines)
- Blood work
Study Days 2-5
- Continue 24hr urine collection
- Start STUDY DIET (10 mEq Na+/day or 300 mEq Na+/day in a random order) after 3 meals of 150 mEq Na+/day are complete; consume 1.5-2 liters of water per day
- On Day 5, a 24 hr Holter combined ECG monitor and BP monitor will be placed on the subjects.
Study Day 6
- Continue STUDY DIET; consume 1.5-2 liters of water per day
- Remove 24hr Holter combined ECG monitor and BP monitor from subject
- Continue 24hr urine collection (for Na+, K+, Cr, fractionated catecholamines)
- Admit to CRC in afternoon (healthy control subjects only, as POTS patients will have already been admitted). Each subject will spend the night in the CRC and remain supine
- Nothing by mouth (NPO) after midnight for study next day
Study Day 7
- Awaken early (~6am) to void (still collecting 24hr urine)
- Patient returns to bed, IV catheter inserted
- Posture Study (in morning; between 7-8am ideally)
- Blood pressure and heart rate will be measured while supine and then while standing for up to 30 minutes
- We will draw blood in each body position to measure electrolytes and hormones that regulate blood pressure and blood volume
- Subjects will rate symptoms during supine period and at end of stand using Vanderbilt Orthostatic Symptoms Score (VOSS)
- Total Blood Volume (DAXOR)- using injection of iodinated I-131 tagged human serum albumin nominally 25 micro-Ci of radiation blood samples drawn through IV catheter before injection and for ~30 minutes post-injection (total - 25 ml)
- This will be done after supine assessment, but before standing the subject up
- Exercise Capacity Test (in the afternoon) Will estimate maximal oxygen consumption (VO2 max). This test will be conducted on a stationary bicycle. Effort will be gradually increased while expired air is measured during exhaustive physical work.
All procedures are repeated at least a month later with the 2nd level of dietary salt. (Randomized to high or low salt in the first phase, the second phase is the remaining level)
- Being tested
- Plasma Volume, Exercise Capacity Test - Bicycle, Posture Study
- Keywords
- Orthostatic Intolerance, Tachycardia, Orthostatic Hypotension, Sodium
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance, Tachycardia, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma VolumeRadiation
Also called DAXOR
Using injection of iodinated I-131 tagged human serum albumin nominally 25 micro-Ci of radiation, blood samples are drawn before and 30 minutes after injection.
Exercise Capacity Test - BicycleProcedure or surgery
Also called VO2 Max (maximal oxygen consumption)
subjects breathe room air through a mouthpiece and exhale the air into a tube that connects to a machine (metabolic cart) that analyzes carbon dioxide and oxygen content, which allows the investigator to calculate the amount of oxygen they are using under resting and exercise conditions.
Posture StudyProcedure or surgery
Also called Standing Orthostatic Challenge
Blood pressure and heart rate will be measured while supine and then while standing for up to 30 minutes. Blood will be drawn in each position to measure hormones that regulate blood pressure and blood volume.
| Study group | Role | What they receive |
|---|---|---|
| High Salt Diet | Experimental | POTS and healthy controls will be randomly assigned the order of dietary sodium levels. All procedures are performed at both levels. The high sodium diet will provide 300 milliequivalents (mEq) sodium/day. Receives: Radiation: Plasma Volume; Procedure: Exercise Capacity Test - Bicycle; Procedure: Posture Study |
| Low Salt Diet | Experimental | POTS and healthy controls will be randomly assigned the order of dietary sodium levels. All procedures are performed at both levels. The low sodium diet will provide 10 mEq sodium/day. Receives: Radiation: Plasma Volume; Procedure: Exercise Capacity Test - Bicycle; Procedure: Posture Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
24hr Urinary Sodium
Amount of sodium excreted in urine over 24hr ending on Day 7
Measured: Day 6 am - Day 7 am for each dietary sodium level
24hr Urinary Dopamine
Amount of dopamine excreted in urine over 24 hours ending on Day 7
Measured: Between Day 6 am - Day 7 am of each dietary sodium level
Secondary outcomes (13)
Plasma Volume
Plasma volume (PV) was determined by the indicator tracer-dilution technique, using the DAXOR Blood Volume Analyzer (BVA)-100 system (DAXOR Corporation), on Day 7 of the low sodium and high sodium dietary interventions.
Measured: after 7 days of each dietary sodium level
Magnitude of Orthostatic Tachycardia
Whether the magnitude of the heart rate increase that occurs in patients with POTS when moving from a supine to an upright position is attenuated by a High Sodium diet relative to a Low Sodium diet.
Heart rate was assessed after overnight rest and fasting after midnight, following at least 60 minutes of lying quietly. Heart rate was then measured at intervals after subjects had been standing for up to 30 minutes (as tolerated). Differences between supine and standing values are presented for 5 minutes standing (or maximal stand if <5 minutes) since several patients were unable to stand for 10 minutes.
Data in POTS patients were compared to that of Healthy Controls.
Measured: Supine and upright heart rate were measured after 6 days of each dietary sodium level
Upright Symptom Score
Whether upright symptoms were improved in patients with POTS on a High Sodium diet relative to a Low Sodium diet.
Patients were asked to report their standing symptom burden at the end of the Stand portion of the posture study, using the Vanderbilt Orthostatic Symptoms Scale (VOSS). They rated the severity of nine symptoms (palpitations, lightheadedness, mental confusion, blurred vision, shortness of breath, tremulousness, chest discomfort, headache, and nausea) on a scale ranging from a minimum of 0 (reflecting an absence of symptoms) to a maximum score of 10. The sum of the individual symptom scores was used to calculate orthostatic symptom burden for each participant. The lowest possible total score was 0, if a participant scored all 9 questions as 0, and the highest possible score was 90, if a participant scored all 9 questions as 10. Higher scores indicated worse symptoms.
Measured: Upright symptoms were assessed on the 6th day of low or high sodium diet.
Urinary Sodium Following Change in Dietary Sodium Days 1-2
Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
Measured: 24 hour collections ending on Day 2 of each diet phase
Urinary Dopamine Following Change in Dietary Sodium Days1-2
Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
Measured: 24 hour collections ending on Day 2 of each dietary sodium phase
Urinary Sodium Following Change in Dietary Sodium Days 2-3
Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
Measured: 24 hour collections ending on Day 3 of each diet phase
Urinary Sodium Following Change in Dietary Sodium Days 3-4
Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
Measured: 24 hour collections ending on Day 4 of each diet phase
Urinary Sodium Following Change in Dietary Sodium Days 4-5
Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets
Measured: 24 hour collections ending on Day 5 of each diet phase
Urinary Sodium Following Change in Dietary Sodium Days 5-6
Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
Measured: 24 hour collections ending on Day 6 of each diet phase
Urinary Dopamine Following Change in Dietary Sodium Days 2-3
Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
Measured: 24 hour collections ending on Day 3 of each dietary sodium phase
Urinary Dopamine Following Change in Dietary Sodium Days 3-4
Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
Measured: 24 hour collections ending on Day 4 of each dietary sodium phase
Urinary Dopamine Following Change in Dietary Sodium Days 4-5
Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
Measured: 24 hour collections ending on Day 5 of each dietary sodium phase
Urinary Dopamine Following Change in Dietary Sodium Days 5-6
Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
Measured: 24 hour collections ending on Day 6 of each dietary sodium phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postural Orthostatic Tachycardia SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomization tables will be used to determine whether the 10 milliequivalents (mEq) sodium/day or 300 mEq sodium/day diet will be consumed first. Both diets will be completed on each subject (randomized crossover study), so all of the study procedures (after screening) will be repeated.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alfredo Gamboa, Vanderbilt University Medical Center
- Investigators
- Alfredo Gamboa, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563107
- Sponsor's protocol ID
- VUMC 111633
- Other IDs
- R01HL071784
- Status last verified
- Dec 2021
- First submitted
- 22 Mar 2012
- Last updated
- 25 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Sodium's Effect on Urinary Sodium and Dopamine Excretion in Patients With Postural Tachycardia Syndrome
- ClinicalTrials.gov ID
- NCT01563107
- Acronym / sponsor ID
- VUMC 111633
- Keywords
- Orthostatic Intolerance, Tachycardia, Orthostatic Hypotension, Sodium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2012
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Posted 25 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Postural Tachycardia Syndrome (POTS) may not adequately expand their plasma volume in response to a high sodium diet. Mechanisms involved in the regulation of plasma volume, such as the renin-angiotensin-aldosterone system and renal dopamine (DA), may be impaired in POTS and may respond inappropriately to changes in dietary sodium. The investigators propose that the changes in urinary sodium and dopamine excretion caused by consuming low-sodium and high-sodium diets will be different between patients with POTS and healthy volunteers. The purpose of this study is to determine (1) whether changes in dietary sodium level appropriately influence sodium excretion in POTS; (2) whether changes in dietary sodium level appropriately influence DA excretion in POTS; (3) whether a high dietary sodium level appropriately expands plasma volume in POTS; and (4) whether patients with POTS have improvements in their orthostatic tachycardia and symptoms as a result of a high dietary sodium level.
Detailed description
Study Day 1
- Start 150 mEq Na+/day diet (POTS patients as inpatients; healthy control subjects with Clinical Research Center(CRC)- provided outpatient diet); consume 1.5-2 liters of water per day
- Start a 24hour (24hr) urine collection (for sodium (Na+), potassium (K+), creatinine (Cr), fractionated catecholamines)
- Blood work
Study Days 2-5
- Continue 24hr urine collection
- Start STUDY DIET (10 mEq Na+/day or 300 mEq Na+/day in a random order) after 3 meals of 150 mEq Na+/day are complete; consume 1.5-2 liters of water per day
- On Day 5, a 24 hr Holter combined ECG monitor and BP monitor will be placed on the subjects.
Study Day 6
- Continue STUDY DIET; consume 1.5-2 liters of water per day
- Remove 24hr Holter combined ECG monitor and BP monitor from subject
- Continue 24hr urine collection (for Na+, K+, Cr, fractionated catecholamines)
- Admit to CRC in afternoon (healthy control subjects only, as POTS patients will have already been admitted). Each subject will spend the night in the CRC and remain supine
- Nothing by mouth (NPO) after midnight for study next day
Study Day 7
- Awaken early (~6am) to void (still collecting 24hr urine)
- Patient returns to bed, IV catheter inserted
- Posture Study (in morning; between 7-8am ideally)
- Blood pressure and heart rate will be measured while supine and then while standing for up to 30 minutes
- We will draw blood in each body position to measure electrolytes and hormones that regulate blood pressure and blood volume
- Subjects will rate symptoms during supine period and at end of stand using Vanderbilt Orthostatic Symptoms Score (VOSS)
- Total Blood Volume (DAXOR)- using injection of iodinated I-131 tagged human serum albumin nominally 25 micro-Ci of radiation blood samples drawn through IV catheter before injection and for ~30 minutes post-injection (total - 25 ml)
- This will be done after supine assessment, but before standing the subject up
- Exercise Capacity Test (in the afternoon) Will estimate maximal oxygen consumption (VO2 max). This test will be conducted on a stationary bicycle. Effort will be gradually increased while expired air is measured during exhaustive physical work.
All procedures are repeated at least a month later with the 2nd level of dietary salt. (Randomized to high or low salt in the first phase, the second phase is the remaining level)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization tables will be used to determine whether the 10 milliequivalents (mEq) sodium/day or 300 mEq sodium/day diet will be consumed first. Both diets will be completed on each subject (randomized crossover study), so all of the study procedures (after screening) will be repeated.
| Arm | Type | Receives |
|---|---|---|
| High Salt Diet | Experimental | Radiation: Plasma Volume, Procedure: Exercise Capacity Test - Bicycle, Procedure: Posture StudyPOTS and healthy controls will be randomly assigned the order of dietary sodium levels. All procedures are performed at both levels. The high sodium diet will provide 300 milliequivalents (mEq) sodium/day. |
| Low Salt Diet | Experimental | Radiation: Plasma Volume, Procedure: Exercise Capacity Test - Bicycle, Procedure: Posture StudyPOTS and healthy controls will be randomly assigned the order of dietary sodium levels. All procedures are performed at both levels. The low sodium diet will provide 10 mEq sodium/day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Premenopausal patients with POTS and healthy volunteers, 18-50 years old, who are non-smokers and free of medications with the potential to influence blood pressure
- Patients diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
- Patients who Increase heart rate ≥30 beats/min with position change from supine to standing (10 minutes)
- For patients, chronic symptoms consistent with POTS that are worse when upright and get better with recumbence
- Only female participants are eligible. Since 80-90% of POTS patients are female, and there can be differences in measures with the menstrual cycle, including a small number of males might introduce a significant amount of noise.
Key exclusion criteria (7 listed)
- Smokers
- Overt cause for postural tachycardia, i.e., acute dehydration
- Significant cardiovascular, pulmonary, hepatic, or hematological disease by history or screening results
- Positive pregnancy test or breastfeeding
- Hypertension defined as BP>145/95 off medications when supine or needing antihypertensive medication
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 |
|---|---|---|
| Plasma VolumeAlso: DAXORUsing injection of iodinated I-131 tagged human serum albumin nominally 25 micro-Ci of radiation, blood samples are drawn before and 30 minutes after injection. | Radiation | High Salt Diet, Low Salt Diet |
| Exercise Capacity Test - BicycleAlso: VO2 Max (maximal oxygen consumption)subjects breathe room air through a mouthpiece and exhale the air into a tube that connects to a machine (metabolic cart) that analyzes carbon dioxide and oxygen content, which allows the investigator to calculate the amount of oxygen they are using under resting and exercise conditions. | Procedure or surgery | High Salt Diet, Low Salt Diet |
| Posture StudyAlso: Standing Orthostatic ChallengeBlood pressure and heart rate will be measured while supine and then while standing for up to 30 minutes. Blood will be drawn in each position to measure hormones that regulate blood pressure and blood volume. | Procedure or surgery | High Salt Diet, Low Salt Diet |
Primary outcome
24hr Urinary Sodium
Time frame: Day 6 am - Day 7 am for each dietary sodium level
Amount of sodium excreted in urine over 24hr ending on Day 7
24hr Urinary Dopamine
Time frame: Between Day 6 am - Day 7 am of each dietary sodium level
Amount of dopamine excreted in urine over 24 hours ending on Day 7
13 secondary outcomes
Plasma Volume
Time frame: after 7 days of each dietary sodium level
Magnitude of Orthostatic Tachycardia
Time frame: Supine and upright heart rate were measured after 6 days of each dietary sodium level
Upright Symptom Score
Time frame: Upright symptoms were assessed on the 6th day of low or high sodium diet.
Urinary Sodium Following Change in Dietary Sodium Days 1-2
Time frame: 24 hour collections ending on Day 2 of each diet phase
Urinary Dopamine Following Change in Dietary Sodium Days1-2
Time frame: 24 hour collections ending on Day 2 of each dietary sodium phase
Urinary Sodium Following Change in Dietary Sodium Days 2-3
Time frame: 24 hour collections ending on Day 3 of each diet phase
Urinary Sodium Following Change in Dietary Sodium Days 3-4
Time frame: 24 hour collections ending on Day 4 of each diet phase
Urinary Sodium Following Change in Dietary Sodium Days 4-5
Time frame: 24 hour collections ending on Day 5 of each diet phase
Urinary Sodium Following Change in Dietary Sodium Days 5-6
Time frame: 24 hour collections ending on Day 6 of each diet phase
Urinary Dopamine Following Change in Dietary Sodium Days 2-3
Time frame: 24 hour collections ending on Day 3 of each dietary sodium phase
Urinary Dopamine Following Change in Dietary Sodium Days 3-4
Time frame: 24 hour collections ending on Day 4 of each dietary sodium phase
Urinary Dopamine Following Change in Dietary Sodium Days 4-5
Time frame: 24 hour collections ending on Day 5 of each dietary sodium phase
Urinary Dopamine Following Change in Dietary Sodium Days 5-6
Time frame: 24 hour collections ending on Day 6 of each dietary sodium phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alfredo Gamboa, MD 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?
A study testing Plasma Volume, Exercise Capacity Test - Bicycle and Posture Study in people with Postural Orthostatic Tachycardia Syndrome, run by Vanderbilt University Medical Center 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 25 Jan 2022. 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?
Yes. Results are posted in the registry (first posted 25 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
24hr Urinary Sodium (time frame: Day 6 am - Day 7 am for each dietary sodium level). The study lists 2 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 25 Jan 2022.