Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
NCT Number: NCT01547117
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.
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37232, United States
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)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: carbon monoxide (CO)-red blood cell (RBC) Blood Volume
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.
Other names: DAXOR
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.
Other names: VO2 Max (maximal oxygen consumption)
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.
Other names: Standing Orthostatic Challenge
Time frame: after 7 days of each dietary sodium level
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.
Time frame: Upright blood samples were collected after up to 30 minutes of standing on the 7th day of each dietary sodium intervention
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.
Time frame: Upright blood samples were collected after up to 30 minutes of standing on the 7th day of each dietary sodium intervention
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.
Time frame: Supine and upright heart rates were measured on Day 7 of High Sodium and Low Sodium diet.
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.
Time frame: Upright symptoms were assessed on the 7th day of diet.
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.
Vanderbilt University
Other
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