Postural Tachycardia Syndrome (POTS)NCT01550315
Effect of Dietary Sodium Intake on Vascular Endothelium
A study testing Pulsitile Arterial Tonometry (PAT) Protocol, Calf Blood Flow in Reactive Hyperemia (CBF-RH) and Evaluation of Forearm-Mediated Dilation in people with Postural Tachycardia Syndrome (POTS), run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The investigators will test the hypothesis that markers of vascular endothelial dysfunction will be exaggerated acutely with an extreme high sodium diet compared to an extreme low-sodium diet. The investigators will compare patients with postural orthostatic tachycardia (POTS) to healthy control subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Tachycardia Syndrome (POTS)
- What is being tested?
- Pulsitile Arterial Tonometry (PAT) Protocol, Calf Blood Flow in Reactive Hyperemia (CBF-RH) and Evaluation of Forearm-Mediated Dilation
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Sep 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be enrolled in the parent study "Dietary Salt in Postural Tachcyardia Syndrome" funded by R01 HL102387 Postural Tachycardia Syndrome
- Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
- Subjects will be enrolled in the parent study "Dietary Salt in Postural Tachcyardia Syndrome" funded by R01 HL102387
- Postural Tachycardia Syndrome
- Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
- Increase in heart rate ≥30 beats/min with position change from supine to standing (10 minutes)
Show all 13Show fewer
- Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence Control Subjects
- Healthy, non-obese, non-smokers without orthostatic tachycardia
- Selected to match profiles of POTS patients (gender, age)
- Not using vasoactive medication
- Age between 18-60 years
- Male and female subjects are eligible.
- Able and willing to provide informed consent
Who cannot join
- Overt cause for postural tachycardia (such as acute dehydration)
- Inability to give, or withdrawal of, informed consent
- Pregnant
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: A Pilot Study of the Effect of Dietary Sodium Intake on Assessments of Vascular Endothelium
The investigators will test the hypothesis that markers of vascular endothelial dysfunction will be exaggerated acutely with an extreme high sodium diet compared to an extreme low-sodium diet. The investigators will compare patients with postural orthostatic tachycardia (POTS) to healthy control subjects.
Read the detailed description
The study will involve a crossover design in which each subject will be assessed (as below) while on a very low-sodium (10 mEq/day) diet compared with a very high-sodium diet. These acute dietary interventions will be part of the parent study ("Dietary Salt in Postural Tachcyardia Syndrome" funded by R01 HL102387) for 4-5 days at the time of the study. Dietary success will be assessed using a 24h urine for sodium and creatinine as a part of the parent study.
Blood will be drawn and collected in a fasting state for future assay and analysis of the following tests:
- Glucose, Insulin (glucose impairment, insulin resistance)
- Fasting lipid profile
- C-Reactive Protein (hsCRP) (inflammatory state)
- Inflammatory cytokines (inflammatory state)
- aliquots (future analysis)
Pulsitile Arterial Tonometry (PAT) Protocol Calf Blood Flow in Reactive Hyperemia (CBF-RH) - venous occlusion plethysmography Evaluation of Forearm-Mediated Dilation
- Conditions
- Postural Tachycardia Syndrome (POTS)
- Being tested
- Pulsitile Arterial Tonometry (PAT) Protocol, Calf Blood Flow in Reactive Hyperemia (CBF-RH), Evaluation of Forearm-Mediated Dilation
- Keywords
- POTS, endothelial function, high salt vs low salt diet, PAT protocol, Calf blood flow, forearm mediated dilation
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsitile Arterial Tonometry (PAT) ProtocolProcedure or surgery
Also called EndoPat
- A blood pressure cuff will be placed on one upper arm (study arm; non-dominant), while the contralateral arm will serve as a control (control arm).
- RH-PAT probes will be placed on one finger (finger II, III, or IV) of each hand (same finger on both hands). The fingers on either side of the one with the probe will be separated using soft sponge rings.
- Continuous recording of pulsatile blood volume responses from both hands will be initiated.
- After a 10-min equilibration period, the blood pressure cuff on the study arm will be inflated to 60 mm Hg above systolic pressure for 5 min. The cuff will then be deflated to induce reactive hyperemia, PAT recording will be stopped.
Calf Blood Flow in Reactive Hyperemia (CBF-RH)Device
Also called Hokansan strain guage venous plethysmography
Calf blood flow (CBF) will be determined using venous occlusion plethysmography and calibrated mercury strain-gauges during reactive hyperemia after a 5 min of ischemia of the distal limb. Strain-gauges will be applied to the widest part of the non-dominant calf (~10 cm below patella). Participants will remain quietly supine for 10 min with legs elevated on foam pads above the right atrium to achieve stable baseline measurements of CBF. The venous occlusion cuff is inflated for 4 seconds at 8 seconds intervals, while monitoring the change in resistance in the system, pressure inside the measuring cuff, and 5-10 determinations are performed
Evaluation of Forearm-Mediated DilationDevice
Also called Ultrasound
The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities.
| Study group | Role | What they receive |
|---|---|---|
| High Sodium - POTS & Controls | Active comparator | Subjects will receive a high sodium diet for 4-5 days prior to study day. Procedures include: blood work, urine collection, Pulsitile Arterial Tonometry (PAT), PAT analysis, Calf Blood Flow in Reactive Hyperemia (CBF-RH), \& evaluation of forearm-mediated dilation. Receives: Procedure: Pulsitile Arterial Tonometry (PAT) Protocol; Device: Calf Blood Flow in Reactive Hyperemia (CBF-RH); Device: Evaluation of Forearm-Mediated Dilation |
| Low Sodium Diet (POTS & Controls) | Other | Participants will consume a very low sodium diet (10 mEq/day) for 4-5 days prior to study day.
Procedures include: blood work, urine collection, Pulsitile Arterial Tonometry (PAT), PAT analysis, Calf Blood Flow in Reactive Hyperemia (CBF-RH), \& evaluation of forearm-mediated dilation. Receives: Procedure: Pulsitile Arterial Tonometry (PAT) Protocol; Device: Calf Blood Flow in Reactive Hyperemia (CBF-RH); Device: Evaluation of Forearm-Mediated Dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMD (% Change)
The primary analysis will involve a non-parametric, paired, Signed Rank test of flow mediated dilation (FMD) between all subjects (POTS \& control subjects) on the high sodium diet vs low sodium diet
Measured: FMD was assessed on the morning of day 7, after 6 days of being on either a high salt diet or a low salt diet.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2020
- Study completionSep 2021
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.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Postural Tachycardia Syndrome (POTS)Studies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alfredo Gamboa, Vanderbilt University Medical Center
- Investigators
- Satish R Raj, MD MSCI, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550315
- Sponsor's protocol ID
- 111577
- Other IDs
- R01HL102387
- Status last verified
- Dec 2021
- First submitted
- 2 Mar 2012
- Last updated
- 5 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Clarkson P, Celermajer DS, Powe AJ, Donald AE, Henry RM, Deanfield JE. Endothelium-dependent dilatation is impaired in young healthy subjects with a family history of premature coronary disease. Circulation. 1997 Nov 18;96(10):3378-83. doi: 10.1161/01.cir.96.10.3378.
PubMed 9396430Al Suwaidi J, Higano ST, Holmes DR Jr, Lennon R, Lerman A. Obesity is independently associated with coronary endothelial dysfunction in patients with normal or mildly diseased coronary arteries. J Am Coll Cardiol. 2001 May;37(6):1523-8. doi: 10.1016/s0735-1097(01)01212-8.
PubMed 11345360Boger RH, Bode-Boger SM, Szuba A, Tsao PS, Chan JR, Tangphao O, Blaschke TF, Cooke JP. Asymmetric dimethylarginine (ADMA): a novel risk factor for endothelial dysfunction: its role in hypercholesterolemia. Circulation. 1998 Nov 3;98(18):1842-7. doi: 10.1161/01.cir.98.18.1842.
PubMed 9799202Mangin EL Jr, Kugiyama K, Nguy JH, Kerns SA, Henry PD. Effects of lysolipids and oxidatively modified low density lipoprotein on endothelium-dependent relaxation of rabbit aorta. Circ Res. 1993 Jan;72(1):161-6. doi: 10.1161/01.res.72.1.161.
PubMed 8417838Vergnani L, Hatrik S, Ricci F, Passaro A, Manzoli N, Zuliani G, Brovkovych V, Fellin R, Malinski T. Effect of native and oxidized low-density lipoprotein on endothelial nitric oxide and superoxide production : key role of L-arginine availability. Circulation. 2000 Mar 21;101(11):1261-6. doi: 10.1161/01.cir.101.11.1261.
PubMed 10725285Landmesser U, Merten R, Spiekermann S, Buttner K, Drexler H, Hornig B. Vascular extracellular superoxide dismutase activity in patients with coronary artery disease: relation to endothelium-dependent vasodilation. Circulation. 2000 May 16;101(19):2264-70. doi: 10.1161/01.cir.101.19.2264.
PubMed 10811593Quyyumi AA, Dakak N, Andrews NP, Husain S, Arora S, Gilligan DM, Panza JA, Cannon RO 3rd. Nitric oxide activity in the human coronary circulation. Impact of risk factors for coronary atherosclerosis. J Clin Invest. 1995 Apr;95(4):1747-55. doi: 10.1172/JCI117852.
PubMed 7706483Appel LJ, Frohlich ED, Hall JE, Pearson TA, Sacco RL, Seals DR, Sacks FM, Smith SC Jr, Vafiadis DK, Van Horn LV. The importance of population-wide sodium reduction as a means to prevent cardiovascular disease and stroke: a call to action from the American Heart Association. Circulation. 2011 Mar 15;123(10):1138-43. doi: 10.1161/CIR.0b013e31820d0793. Epub 2011 Jan 13. No abstract available.
PubMed 21233236Meneton P, Jeunemaitre X, de Wardener HE, MacGregor GA. Links between dietary salt intake, renal salt handling, blood pressure, and cardiovascular diseases. Physiol Rev. 2005 Apr;85(2):679-715. doi: 10.1152/physrev.00056.2003.
PubMed 15788708MENEELY GR, BALL CO. Experimental epidemiology of chronic sodium chloride toxicity and the protective effect of potassium chloride. Am J Med. 1958 Nov;25(5):713-25. doi: 10.1016/0002-9343(58)90009-3. No abstract available.
PubMed 13582981Strazzullo P, D'Elia L, Kandala NB, Cappuccio FP. Salt intake, stroke, and cardiovascular disease: meta-analysis of prospective studies. BMJ. 2009 Nov 24;339:b4567. doi: 10.1136/bmj.b4567.
PubMed 19934192Dishy V, Sofowora GG, Imamura H, Nishimi Y, Xie HG, Wood AJ, Stein CM. Nitric oxide production decreases after salt loading but is not related to blood pressure changes or nitric oxide-mediated vascular responses. J Hypertens. 2003 Jan;21(1):153-7. doi: 10.1097/00004872-200301000-00025.
PubMed 12544447Fujiwara N, Osanai T, Kamada T, Katoh T, Takahashi K, Okumura K. Study on the relationship between plasma nitrite and nitrate level and salt sensitivity in human hypertension : modulation of nitric oxide synthesis by salt intake. Circulation. 2000 Feb 29;101(8):856-61. doi: 10.1161/01.cir.101.8.856.
PubMed 10694524Kuvin JT, Patel AR, Sliney KA, Pandian NG, Sheffy J, Schnall RP, Karas RH, Udelson JE. Assessment of peripheral vascular endothelial function with finger arterial pulse wave amplitude. Am Heart J. 2003 Jul;146(1):168-74. doi: 10.1016/S0002-8703(03)00094-2.
PubMed 12851627Rozanski A, Qureshi E, Bauman M, Reed G, Pillar G, Diamond GA. Peripheral arterial responses to treadmill exercise among healthy subjects and atherosclerotic patients. Circulation. 2001 Apr 24;103(16):2084-9. doi: 10.1161/01.cir.103.16.2084.
PubMed 11319199
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Dietary Sodium Intake on Assessments of Vascular Endothelium
- ClinicalTrials.gov ID
- NCT01550315
- Acronym / sponsor ID
- 111577
- Conditions
- Postural Tachycardia Syndrome (POTS)
- Keywords
- POTS, endothelial function, high salt vs low salt diet, PAT protocol, Calf blood flow, forearm mediated dilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2012
- Primary completion
- Dec 2020 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Posted 5 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will test the hypothesis that markers of vascular endothelial dysfunction will be exaggerated acutely with an extreme high sodium diet compared to an extreme low-sodium diet. The investigators will compare patients with postural orthostatic tachycardia (POTS) to healthy control subjects.
Detailed description
The study will involve a crossover design in which each subject will be assessed (as below) while on a very low-sodium (10 mEq/day) diet compared with a very high-sodium diet. These acute dietary interventions will be part of the parent study ("Dietary Salt in Postural Tachcyardia Syndrome" funded by R01 HL102387) for 4-5 days at the time of the study. Dietary success will be assessed using a 24h urine for sodium and creatinine as a part of the parent study.
Blood will be drawn and collected in a fasting state for future assay and analysis of the following tests:
- Glucose, Insulin (glucose impairment, insulin resistance)
- Fasting lipid profile
- C-Reactive Protein (hsCRP) (inflammatory state)
- Inflammatory cytokines (inflammatory state)
- aliquots (future analysis)
Pulsitile Arterial Tonometry (PAT) Protocol Calf Blood Flow in Reactive Hyperemia (CBF-RH) - venous occlusion plethysmography Evaluation of Forearm-Mediated Dilation
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Sodium - POTS & Controls | Active comparator | Procedure: Pulsitile Arterial Tonometry (PAT) Protocol, Device: Calf Blood Flow in Reactive Hyperemia (CBF-RH), Device: Evaluation of Forearm-Mediated DilationSubjects will receive a high sodium diet for 4-5 days prior to study day. Procedures include: blood work, urine collection, Pulsitile Arterial Tonometry (PAT), PAT analysis, Calf Blood Flow in Reactive Hyperemia (CBF-RH), \& evaluation of forearm-mediated dilation. |
| Low Sodium Diet (POTS & Controls) | Other | Procedure: Pulsitile Arterial Tonometry (PAT) Protocol, Device: Calf Blood Flow in Reactive Hyperemia (CBF-RH), Device: Evaluation of Forearm-Mediated DilationParticipants will consume a very low sodium diet (10 mEq/day) for 4-5 days prior to study day. Procedures include: blood work, urine collection, Pulsitile Arterial Tonometry (PAT), PAT analysis, Calf Blood Flow in Reactive Hyperemia (CBF-RH), \& evaluation of forearm-mediated dilation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects will be enrolled in the parent study "Dietary Salt in Postural Tachcyardia Syndrome" funded by R01 HL102387 Postural Tachycardia Syndrome
- Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
- Subjects will be enrolled in the parent study "Dietary Salt in Postural Tachcyardia Syndrome" funded by R01 HL102387
- Postural Tachycardia Syndrome
- Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
Key exclusion criteria (4 listed)
- Overt cause for postural tachycardia (such as acute dehydration)
- Inability to give, or withdrawal of, informed consent
- Pregnant
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
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 |
|---|---|---|
| Pulsitile Arterial Tonometry (PAT) ProtocolAlso: EndoPat* A blood pressure cuff will be placed on one upper arm (study arm; non-dominant), while the contralateral arm will serve as a control (control arm). * RH-PAT probes will be placed on one finger (finger II, III, or IV) of each hand (same finger on both hands). The fingers on either side of the one with the probe will be separated using soft sponge rings. * Continuous recording of pulsatile blood volume responses from both hands will be initiated. * After a 10-min equilibration period, the blood pressure cuff on the study arm will be inflated to 60 mm Hg above systolic pressure for 5 min. The cuff will then be deflated to induce reactive hyperemia, PAT recording will be stopped. | Procedure or surgery | High Sodium - POTS & Controls, Low Sodium Diet (POTS & Controls) |
| Calf Blood Flow in Reactive Hyperemia (CBF-RH)Also: Hokansan strain guage venous plethysmographyCalf blood flow (CBF) will be determined using venous occlusion plethysmography and calibrated mercury strain-gauges during reactive hyperemia after a 5 min of ischemia of the distal limb. Strain-gauges will be applied to the widest part of the non-dominant calf (~10 cm below patella). Participants will remain quietly supine for 10 min with legs elevated on foam pads above the right atrium to achieve stable baseline measurements of CBF. The venous occlusion cuff is inflated for 4 seconds at 8 seconds intervals, while monitoring the change in resistance in the system, pressure inside the measuring cuff, and 5-10 determinations are performed | Device | High Sodium - POTS & Controls, Low Sodium Diet (POTS & Controls) |
| Evaluation of Forearm-Mediated DilationAlso: UltrasoundThe arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities. | Device | High Sodium - POTS & Controls, Low Sodium Diet (POTS & Controls) |
Primary outcome
FMD (% Change)
Time frame: FMD was assessed on the morning of day 7, after 6 days of being on either a high salt diet or a low salt diet.
The primary analysis will involve a non-parametric, paired, Signed Rank test of flow mediated dilation (FMD) between all subjects (POTS \& control subjects) on the high sodium diet vs low sodium diet
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9396430Clarkson P, Celermajer DS, Powe AJ, Donald AE, Henry RM, Deanfield JE. Endothelium-dependent dilatation is impaired in young healthy subjects with a family history of premature coronary disease. Circulation. 1997 Nov 18;96(10):3378-83. doi: 10.1161/01.cir.96.10.3378.
- Background: PubMed 11345360Al Suwaidi J, Higano ST, Holmes DR Jr, Lennon R, Lerman A. Obesity is independently associated with coronary endothelial dysfunction in patients with normal or mildly diseased coronary arteries. J Am Coll Cardiol. 2001 May;37(6):1523-8. doi: 10.1016/s0735-1097(01)01212-8.
- Background: PubMed 9799202Boger RH, Bode-Boger SM, Szuba A, Tsao PS, Chan JR, Tangphao O, Blaschke TF, Cooke JP. Asymmetric dimethylarginine (ADMA): a novel risk factor for endothelial dysfunction: its role in hypercholesterolemia. Circulation. 1998 Nov 3;98(18):1842-7. doi: 10.1161/01.cir.98.18.1842.
- Background: PubMed 8417838Mangin EL Jr, Kugiyama K, Nguy JH, Kerns SA, Henry PD. Effects of lysolipids and oxidatively modified low density lipoprotein on endothelium-dependent relaxation of rabbit aorta. Circ Res. 1993 Jan;72(1):161-6. doi: 10.1161/01.res.72.1.161.
- Background: PubMed 10725285Vergnani L, Hatrik S, Ricci F, Passaro A, Manzoli N, Zuliani G, Brovkovych V, Fellin R, Malinski T. Effect of native and oxidized low-density lipoprotein on endothelial nitric oxide and superoxide production : key role of L-arginine availability. Circulation. 2000 Mar 21;101(11):1261-6. doi: 10.1161/01.cir.101.11.1261.
- Background: PubMed 10811593Landmesser U, Merten R, Spiekermann S, Buttner K, Drexler H, Hornig B. Vascular extracellular superoxide dismutase activity in patients with coronary artery disease: relation to endothelium-dependent vasodilation. Circulation. 2000 May 16;101(19):2264-70. doi: 10.1161/01.cir.101.19.2264.
- Background: PubMed 7706483Quyyumi AA, Dakak N, Andrews NP, Husain S, Arora S, Gilligan DM, Panza JA, Cannon RO 3rd. Nitric oxide activity in the human coronary circulation. Impact of risk factors for coronary atherosclerosis. J Clin Invest. 1995 Apr;95(4):1747-55. doi: 10.1172/JCI117852.
- Background: PubMed 21233236Appel LJ, Frohlich ED, Hall JE, Pearson TA, Sacco RL, Seals DR, Sacks FM, Smith SC Jr, Vafiadis DK, Van Horn LV. The importance of population-wide sodium reduction as a means to prevent cardiovascular disease and stroke: a call to action from the American Heart Association. Circulation. 2011 Mar 15;123(10):1138-43. doi: 10.1161/CIR.0b013e31820d0793. Epub 2011 Jan 13. No abstract available.
- Background: PubMed 15788708Meneton P, Jeunemaitre X, de Wardener HE, MacGregor GA. Links between dietary salt intake, renal salt handling, blood pressure, and cardiovascular diseases. Physiol Rev. 2005 Apr;85(2):679-715. doi: 10.1152/physrev.00056.2003.
- Background: PubMed 13582981MENEELY GR, BALL CO. Experimental epidemiology of chronic sodium chloride toxicity and the protective effect of potassium chloride. Am J Med. 1958 Nov;25(5):713-25. doi: 10.1016/0002-9343(58)90009-3. No abstract available.
- Background: PubMed 19934192Strazzullo P, D'Elia L, Kandala NB, Cappuccio FP. Salt intake, stroke, and cardiovascular disease: meta-analysis of prospective studies. BMJ. 2009 Nov 24;339:b4567. doi: 10.1136/bmj.b4567.
- Background: PubMed 12544447Dishy V, Sofowora GG, Imamura H, Nishimi Y, Xie HG, Wood AJ, Stein CM. Nitric oxide production decreases after salt loading but is not related to blood pressure changes or nitric oxide-mediated vascular responses. J Hypertens. 2003 Jan;21(1):153-7. doi: 10.1097/00004872-200301000-00025.
Related trials for Postural Tachycardia Syndrome (POTS)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Enrolling by invitationObservational study
Presentation of Young Adults With and Without Joint Hypermobility
Hypermobile Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome (POTS)
Active, not recruitingObservational study
POTS NET mRNA Functional Correlation With NET Activity
Postural Tachycardia Syndrome
Active, not recruitingObservational study
Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)
Postural Tachycardia Syndrome, Orthostatic Intolerance
Active, not recruiting
Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)
Postural Tachycardia Syndrome
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.
Satish R Raj, MD MSCI principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsitile Arterial Tonometry (PAT) Protocol, Calf Blood Flow in Reactive Hyperemia (CBF-RH) and Evaluation of Forearm-Mediated Dilation in people with Postural Tachycardia Syndrome (POTS), 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 13 inclusion and 4 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 5 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 5 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?
FMD (% Change) (time frame: FMD was assessed on the morning of day 7, after 6 days of being on either a high salt diet or a low salt diet.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01550315, which also lists 26 linked publications.
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 5 Jan 2022.