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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL102387 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Patients with POTS may not adequately expand their plasma volume in response to a high-sodium (Na+) diet. Mechanisms involved in the regulation of plasma volume, such as the renin-angiotensin-aldosterone system and renal dopamine, may be impaired in POTS and may respond inappropriately to changes in dietary sodium.The purpose of this study is to determine (1) whether a high dietary sodium level appropriately expands plasma volume in POTS; (2) whether plasma renin activity and aldosterone are modified appropriately by changes in dietary sodium in POTS; and (3) whether patients with POTS have improvements in their orthostatic tachycardia and symptoms as a result of a high dietary sodium level.
Study Day 1
Study Day 2
Study Day 3 - 5
Study Day 6
Study Day 7 (BIG DAY)
All procedures are repeated at least a month later with the 2nd level of dietary salt. (Randomized to high or low salt to the first phase, the second phase is the remaining level)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Sodium Level | 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. |
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| Low Sodium Dietary Level | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Volume | Radiation | we will measure the amount of hemoglobin and myoglobin in the body by a procedure called CO rebreathing. One teaspoon of blood is taken before and after a small amount of CO has been absorbed into the bloodstream. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. Outcome data are the absolute values for PV on Day 7 for each diet. | after 7 days of each dietary sodium level |
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of Suppression of Plasma Renin Activity (From Low Sodium to High Sodium Diets) | Whether upright plasma renin activity was modified appropriately by changes in dietary sodium in POTS & healthy controls. Outcome data are the absolute values for upright plasma renin activity on Day 7 of each diet. | Upright blood samples were collected after up to 30 minutes of standing on the 7th day of each dietary sodium intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of Suppression of Serum Aldosterone (From Low Sodium to High Sodium Diets) | Whether upright serum aldosterone was modified appropriately by changes in dietary sodium in POTS patients & healthy controls. Outcome data are the absolute values for upright serum aldosterone on Day 7 of each diet. | Upright blood samples were collected after up to 30 minutes of standing on the 7th day of each dietary sodium intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfredo J Gamboa, MD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37393658 | Derived | Laurin JKH, Oyewunmi OA, Garland EM, Gamboa A, Nwazue VC, Paranjape SY, Black BK, Okamoto LE, Shibao CA, Biaggioni I, Robertson D, Diedrich A, Dupont WD, Sheldon RS, Raj SR. Adrenal gland response to adrenocorticotropic hormone is intact in patients with postural orthostatic tachycardia syndrome. Auton Neurosci. 2023 Sep;248:103105. doi: 10.1016/j.autneu.2023.103105. Epub 2023 Jun 24. | |
| 33926653 | Derived | Garland EM, Gamboa A, Nwazue VC, Celedonio JE, Paranjape SY, Black BK, Okamoto LE, Shibao CA, Biaggioni I, Robertson D, Diedrich A, Dupont WD, Raj SR. Effect of High Dietary Sodium Intake in Patients With Postural Tachycardia Syndrome. J Am Coll Cardiol. 2021 May 4;77(17):2174-2184. doi: 10.1016/j.jacc.2021.03.005. |
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Healthy Participants: 17 were enrolled and randomized. 1 withdrew due to scheduling. 1 withdrew with migraines in phase 1 (low Na+). 2 withdrew in phase 1 (high Na+): 1 unable to tolerate study diet and another had difficulty cooperating with investigators.
Postural Tachycardia Syndrome (POTS): 21 were enrolled and randomized. 6 withdrew before baseline due to age (1), pregnancy (1), prohibited meds (3), and scheduling (1). A 7th patient withdrew during phase 1 (high Na+) due to family illness.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Participants-Low Na+ Then High Na+ | Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 milliequivalents (mEq) sodium/day, 12 participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels. |
| FG001 | Healthy Participants-High Na+ Then Low Na+ | Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 mEq sodium/day, 5 participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels. |
| FG002 | Patients With POTS-Low Na+ Then High Na+ | Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 mEq sodium/day, 10 participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels. |
| FG003 | Patients With POTS-High Na+ Then Low Na+ | Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 mEq sodium/day, 11 participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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14 patients with Postural Tachycardia Syndrome (POTS) and 13 Controls underwent testing while on a High Sodium Diet and while on a Low Sodium Diet, administered in a randomly assigned order. Baseline data were collected prior to starting the first dietary phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Participants-Low Na+ Then High Na+ | Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. Outcome data are the absolute values for PV on Day 7 for each diet. | No data analysis for 1 healthy control who had poor venous access on Day 7 of the high sodium diet. | Posted | Median | Inter-Quartile Range | mL | after 7 days of each dietary sodium level |
|
Adverse event data were collected through discharge on the last day of phase 2 of the study. This would have been Day 8 if Low Sodium diet or Day 7 if High Sodium diet.
Adverse event information was collected for any untoward or unfavorable medical occurence in a participant including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B | Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Participant notified the PI that a mass had been discovered on her pineal gland during a brain MRI for another research study. We do not believe that the mass is related to any study procedures undertaken as part of this research protocol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alfredo Gamboa, MD | Vanderbilt University Medical Center | 6158751003 | alfredo.gamboa@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2014 | May 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| D054971 | Orthostatic Intolerance |
| ID | Term |
|---|---|
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D001810 | Blood Volume |
| D002248 | Carbon Monoxide |
| D004906 | Erythrocyte Count |
| ID | Term |
|---|---|
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
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Randomization tables will be used to determine whether the 10 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.
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|
| Total Blood Volume | Radiation | Using injection of iodinated I-131 tagged human serum albumin nominally 25 microcuries of radiation, blood samples are drawn before and 30 minutes after injection. |
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| Exercise Capacity Test - Bicycle | Procedure | subjects breath 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. |
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| Posture Study | Procedure | 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. |
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| 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). Orthostatic tachycardia was calculated as the difference between standing and lying heart rates. Data 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. | Supine and upright heart rates were measured on Day 7 of High Sodium and Low Sodium diet. |
| 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 from a minimum of 0 (reflecting an absence of symptoms) to a maximum of 10. The sum of the scores for the 9 symptoms was used to measure orthostatic symptom burden. Higher scores represent worse symptoms. | Upright symptoms were assessed on the 7th day of diet. |
| Withdrawal by Subject |
|
| BG001 | Healthy Participants-High Na+ Then Low Na+ | Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels. |
| BG002 | Patients With POTS-Low Na+ Then High Na+ | Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels. |
| BG003 | Patients With POTS-High Na+ Then Low Na+ | Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B | Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet. |
| OG002 | Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet. | Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet. Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet. |
| OG003 | Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet. | Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet. Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet. |
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| Secondary | Magnitude of Suppression of Plasma Renin Activity (From Low Sodium to High Sodium Diets) | Whether upright plasma renin activity was modified appropriately by changes in dietary sodium in POTS & healthy controls. Outcome data are the absolute values for upright plasma renin activity on Day 7 of each diet. | Healthy Controls on Low Sodium diet - 1 missing blood sample; Healthy Controls on High Sodium diet - 3 missing blood samples, 2 samples with insufficient volume for analysis; POTS patients on Low Sodium diet - 1 missing blood sample; POTS patients on High Sodium diet - 2 missing blood samples | Posted | Median | Inter-Quartile Range | ng/mL/hr | Upright blood samples were collected after up to 30 minutes of standing on the 7th day of each dietary sodium intervention |
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| Other Pre-specified | Magnitude of Suppression of Serum Aldosterone (From Low Sodium to High Sodium Diets) | Whether upright serum aldosterone was modified appropriately by changes in dietary sodium in POTS patients & healthy controls. Outcome data are the absolute values for upright serum aldosterone on Day 7 of each diet. | Samples were analyzed from each participant | Posted | Median | Inter-Quartile Range | ng/dL | Upright blood samples were collected after up to 30 minutes of standing on the 7th day of each dietary sodium intervention |
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| Other Pre-specified | 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). Orthostatic tachycardia was calculated as the difference between standing and lying heart rates. Data 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. | Data is not included for 1 patient with POTS on a Low Sodium diet since that patient was unable to stand for even 1 minute. | Posted | Median | Inter-Quartile Range | beats per minute | Supine and upright heart rates were measured on Day 7 of High Sodium and Low Sodium diet. |
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| Other Pre-specified | 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 from a minimum of 0 (reflecting an absence of symptoms) to a maximum of 10. The sum of the scores for the 9 symptoms was used to measure orthostatic symptom burden. Higher scores represent worse symptoms. | Upright symptom scores were inadvertently not obtained for the following number of participants: Healthy Participants on Low Sodium diet: 3 Healthy Participants on High Sodium diet: 2 Patients with POTS on Low Sodium diet: 5 Patients with POTS on High Sodium diet: 6 | Posted | Median | Inter-Quartile Range | score on a scale | Upright symptoms were assessed on the 7th day of diet. |
|
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|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B | Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. | 0 | 13 | 0 | 13 | 1 | 13 |
| EG002 | Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet. | Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet. | Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D001772 | Blood Cell Count |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |