Postural Tachycardia SyndromeNCT01000350
Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)
A study testing Saline in people with Postural Tachycardia Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postural Tachycardia Syndrome
- What is being tested?
- Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet diagnostic criteria of Postural Tachycardia Syndrome (POTS) 28
- Age between 18-65 years
- Male and female are eligible (although the majority of POTS patients are female).
- Able and willing to provide informed consent
Who cannot join
- Presence of medical conditions that can explain postural tachycardia (e.g., acute dehydration, medications)
- Pregnancy
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
- Patients who are bedridden or chair-ridden
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University
Nashville, Tennessee, 37232-2195
About this study
Official title: Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance
The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).
- Conditions
- Postural Tachycardia Syndrome
- Being tested
- Saline, Placebo
- Keywords
- orthostatic intolerance, exercise capacity, tachycardia, POTS
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Also called Normal Saline, 0.9% saline
IV Normal Saline infused over 30-60 minutes given 3-6 hours PRIOR to exercise study
PlaceboOther
Placebo x1 lactose tablet
| Study group | Role | What they receive |
|---|---|---|
| Exercise Post Saline | Experimental | Saline infusion 1L hours before exercise test Receives: Drug: Saline |
| Placebo | Placebo comparator | Placebo given prior to exercise test Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in VO2max between saline day and placebo day
VO2max will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.
Measured: Within 2 week
Secondary outcomes (2)
Exercise capacity/Maximal Load (Watts) during peak VO2
Maximal exercise load will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.
Measured: Less than 2 weeks
Cardiac output between exercise tests (inert gas rebreathing technique)
Measured: 2-10 Days between exercise tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postural 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satish R. Raj, Vanderbilt University Medical Center
- Investigators
- Satish R Raj, MD MSCI, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000350
- Sponsor's protocol ID
- 090942
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2009
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Raj SR, Biaggioni I, Yamhure PC, Black BK, Paranjape SY, Byrne DW, Robertson D. Renin-aldosterone paradox and perturbed blood volume regulation underlying postural tachycardia syndrome. Circulation. 2005 Apr 5;111(13):1574-82. doi: 10.1161/01.CIR.0000160356.97313.5D. Epub 2005 Mar 21.
PubMed 15781744
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance
- ClinicalTrials.gov ID
- NCT01000350
- Acronym / sponsor ID
- 090942
- Conditions
- Postural Tachycardia Syndrome
- Keywords
- orthostatic intolerance, exercise capacity, tachycardia, POTS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
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 whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Post Saline | Experimental | Drug: SalineSaline infusion 1L hours before exercise test |
| Placebo | Placebo comparator | Other: PlaceboPlacebo given prior to exercise test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet diagnostic criteria of Postural Tachycardia Syndrome (POTS) 28
- Age between 18-65 years
- Male and female are eligible (although the majority of POTS patients are female).
- Able and willing to provide informed consent
Key exclusion criteria (4 listed)
- Presence of medical conditions that can explain postural tachycardia (e.g., acute dehydration, medications)
- Pregnancy
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
- Patients who are bedridden or chair-ridden
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 |
|---|---|---|
| SalineAlso: Normal Saline, 0.9% salineIV Normal Saline infused over 30-60 minutes given 3-6 hours PRIOR to exercise study | Drug | Exercise Post Saline |
| PlaceboPlacebo x1 lactose tablet | Other | Placebo |
Primary outcome
Difference in VO2max between saline day and placebo day
Time frame: Within 2 week
VO2max will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.
2 secondary outcomes
Exercise capacity/Maximal Load (Watts) during peak VO2
Time frame: Less than 2 weeks
Cardiac output between exercise tests (inert gas rebreathing technique)
Time frame: 2-10 Days between exercise tests
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 15781744Raj SR, Biaggioni I, Yamhure PC, Black BK, Paranjape SY, Byrne DW, Robertson D. Renin-aldosterone paradox and perturbed blood volume regulation underlying postural tachycardia syndrome. Circulation. 2005 Apr 5;111(13):1574-82. doi: 10.1161/01.CIR.0000160356.97313.5D. Epub 2005 Mar 21.
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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.
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 Saline in people with Postural 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 4 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Difference in VO2max between saline day and placebo day (time frame: Within 2 week). 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 NCT01000350, which also lists 1 linked publication.
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 16 Oct 2026.