Postural Orthostatic Tachycardia Syndrome (POTS)Phase 1NCT00962949
The Renin-Aldosterone Axis in Postural Tachycardia Syndrome
A Phase 1 study testing Angiotensin II in people with Postural Orthostatic Tachycardia Syndrome (POTS), run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in the pathophysiology of postural tachycardia syndrome, and to provide an insight about the disease process in this disorder. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome (POTS)
- What is being tested?
- Angiotensin II
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2012
- Phase
- Phase 1
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center criteria
- Age between 18-64 years
- Male or females are eligible
- Able and willing to provide informed consent
- Healthy control subjects with no major medical problem (including postural tachycardia syndrome), free of medications during the study
Who cannot join
- Overt cause of postural tachycardia e.g., dehydration
- Inability to give or withdraw informed consent
- Pregnancy
- Hypertension (BP > 140/90)
- Significant co-morbid condition
- 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.
About this study
The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in the pathophysiology of postural tachycardia syndrome, and to provide an insight about the disease process in this disorder.
- Being tested
- Angiotensin II
- Keywords
- POTS, Orthostatic intolerance
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin IIDrug
Angiotensin II infusion for 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Healthy controls Receives: Drug: Angiotensin II |
| Postural Tachycardia Syndrome | Experimental | Patients with Postural Tachycardia Syndrome Receives: Drug: Angiotensin II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Blood Pressure Change
Change in MAP from baseline to after 1h of infusion.
Measured: 1 hour
Secondary outcomes (3)
Plasma Renin Activity
Change in plasma renin activity from baseline to after 1h of infusion.
Measured: 1 hour
Aldosterone Level
Change in aldosterone blood level from baseline to after 1h of infusion.
Measured: 1 hour
Cortisol Level
Change in cortisol blood level from baseline to after 1h of infusion.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2012
- Study completionDec 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for Postural Orthostatic 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962949
- Sponsor's protocol ID
- 081398
- Other IDs
- PF334
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2009
- Last updated
- 16 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mustafa HI, Raj SR, Diedrich A, Black BK, Paranjape SY, Dupont WD, Williams GH, Biaggioni I, Robertson D. Altered systemic hemodynamic and baroreflex response to angiotensin II in postural tachycardia syndrome. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):173-80. doi: 10.1161/CIRCEP.111.965343. Epub 2012 Jan 13.
PubMed 22247480
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Renin-Aldosterone Axis in Postural Tachycardia Syndrome
- ClinicalTrials.gov ID
- NCT00962949
- Acronym / sponsor ID
- 081398
- Keywords
- POTS, Orthostatic intolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Aug 2009 (estimated)
- Results
- Posted 17 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in the pathophysiology of postural tachycardia syndrome, and to provide an insight about the disease process in this disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Drug: Angiotensin IIHealthy controls |
| Postural Tachycardia Syndrome | Experimental | Drug: Angiotensin IIPatients with Postural Tachycardia Syndrome |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center criteria
- Age between 18-64 years
- Male or females are eligible
- Able and willing to provide informed consent
- Healthy control subjects with no major medical problem (including postural tachycardia syndrome), free of medications during the study
Key exclusion criteria (6 listed)
- Overt cause of postural tachycardia e.g., dehydration
- Inability to give or withdraw informed consent
- Pregnancy
- Hypertension (BP > 140/90)
- Significant co-morbid condition
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 |
|---|---|---|
| Angiotensin IIAngiotensin II infusion for 1 hour | Drug | Control, Postural Tachycardia Syndrome |
Primary outcome
Mean Arterial Blood Pressure Change
Time frame: 1 hour
Change in MAP from baseline to after 1h of infusion.
3 secondary outcomes
Plasma Renin Activity
Time frame: 1 hour
Aldosterone Level
Time frame: 1 hour
Cortisol Level
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22247480Mustafa HI, Raj SR, Diedrich A, Black BK, Paranjape SY, Dupont WD, Williams GH, Biaggioni I, Robertson D. Altered systemic hemodynamic and baroreflex response to angiotensin II in postural tachycardia syndrome. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):173-80. doi: 10.1161/CIRCEP.111.965343. Epub 2012 Jan 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Angiotensin II in people with Postural Orthostatic 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 5 inclusion and 6 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 16 Sep 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2018). 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?
Mean Arterial Blood Pressure Change (time frame: 1 hour). 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 NCT00962949, 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 Sep 2025.