POTS - Postural Orthostatic Tachycardia SyndromePhase 2NCT07197905
Restoring Iron Deficiency in POTS
A Phase 2 study testing Intravenous iron in people with POTS - Postural Orthostatic Tachycardia Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
People with postural orthostatic tachycardia syndrome (POTS) often have low red blood cell volumes and low ferritin in their blood (a marker of iron storage in the body). The purpose of this pilot study is to investigate whether giving iron to people with POTS who have low ferritin levels will increase the red blood… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- POTS - Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- Intravenous iron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2025to Dec 2026
- Phase
- Phase 2
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years old.
- Diagnosis of POTS, defined by a sustained heart rate increase of at least 30 bpm within 10 min of standing or head-up tilt (or absolute upright heart rate >120 bpm), in the absence of orthostatic hypotension, and with at least 3 months of symptoms of orthostatic intolerance.
- Absence of other diseases or medications that can explain orthostatic tachycardia or symptoms.
- Serum ferritin <50 ng/ml.
- Patients on fludrocortisone will be allowed to participate as long as they have been on the same dose for at least one month before enrollment and continue on the same dose throughout the study.
Who cannot join
- Unable or unwilling to provide consent.
- Pregnancy.
- Being chair- or bed-ridden.
- Unable to hold POTS medications during study procedures (i.e., autonomic testing).
- History of active bleeding (other than menstruation).
- History of hypersensitivity to any iron preparation of recent (within 6 months) treatment with any IV iron preparation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Restoring Iron Deficiency to Expand Blood Volume and Improve POTS
People with postural orthostatic tachycardia syndrome (POTS) often have low red blood cell volumes and low ferritin in their blood (a marker of iron storage in the body). The purpose of this pilot study is to investigate whether giving iron to people with POTS who have low ferritin levels will increase the red blood cell volume and improve POTS symptoms.
Read the detailed description
This pilot study involves undergoing a physical exam and medical history, answering some questionnaires, and visiting the Vanderbilt Autonomic Dysfunction Center before and 2 months after the iron treatment for bloodwork, blood volume measurements, autonomic function tests, and wearing an activity monitor.
- Being tested
- Intravenous iron
- Keywords
- Postural Tachycardia Syndrome, Iron Deficiency
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ironDrug
The Intravenous iron infusion will be administered according to standard clinical care. The provider will choose the dosage and formulation of IV iron.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Iron Infusion | Experimental | The Intravenous iron infusion will be administered according to standard clinical care. Receives: Drug: Intravenous iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthostatic tachycardia
Orthostatic tachycardia, defined as the difference between upright and supine heart rates, will be assessed during a 10-minute head-up tilt test.
Measured: Orthostatic tachycardia will be assessed before iron infusion (Visit 1) and after 2 months of treatment (Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start24 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POTS - Postural Orthostatic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dysautonomia International
- Responsible party
- Principal investigator, Italo Biaggioni, Vanderbilt University Medical Center
- Investigators
- Italo Biaggioni, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197905
- Sponsor's protocol ID
- 250671
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Iron Deficiency to Expand Blood Volume and Improve POTS
- ClinicalTrials.gov ID
- NCT07197905
- Acronym / sponsor ID
- 250671
- Keywords
- Postural Tachycardia Syndrome, Iron Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Dysautonomia International
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- 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.
People with postural orthostatic tachycardia syndrome (POTS) often have low red blood cell volumes and low ferritin in their blood (a marker of iron storage in the body). The purpose of this pilot study is to investigate whether giving iron to people with POTS who have low ferritin levels will increase the red blood cell volume and improve POTS symptoms.
Detailed description
This pilot study involves undergoing a physical exam and medical history, answering some questionnaires, and visiting the Vanderbilt Autonomic Dysfunction Center before and 2 months after the iron treatment for bloodwork, blood volume measurements, autonomic function tests, and wearing an activity monitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous Iron Infusion | Experimental | Drug: Intravenous ironThe Intravenous iron infusion will be administered according to standard clinical care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-45 years old.
- Diagnosis of POTS, defined by a sustained heart rate increase of at least 30 bpm within 10 min of standing or head-up tilt (or absolute upright heart rate >120 bpm), in the absence of orthostatic hypotension, and with at least 3 months of symptoms of orthostatic intolerance.
- Absence of other diseases or medications that can explain orthostatic tachycardia or symptoms.
- Serum ferritin <50 ng/ml.
- Patients on fludrocortisone will be allowed to participate as long as they have been on the same dose for at least one month before enrollment and continue on the same dose throughout the study.
Key exclusion criteria (6 listed)
- Unable or unwilling to provide consent.
- Pregnancy.
- Being chair- or bed-ridden.
- Unable to hold POTS medications during study procedures (i.e., autonomic testing).
- History of active bleeding (other than menstruation).
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 |
|---|---|---|
| Intravenous ironThe Intravenous iron infusion will be administered according to standard clinical care. The provider will choose the dosage and formulation of IV iron. | Drug | Intravenous Iron Infusion |
Primary outcome
Orthostatic tachycardia
Time frame: Orthostatic tachycardia will be assessed before iron infusion (Visit 1) and after 2 months of treatment (Visit 2)
Orthostatic tachycardia, defined as the difference between upright and supine heart rates, will be assessed during a 10-minute head-up tilt test.
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Italo Biaggioni, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous iron in people with POTS - Postural Orthostatic 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 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: under way, not looking for participants, as of the sponsor's last update on 13 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Orthostatic tachycardia (time frame: Orthostatic tachycardia will be assessed before iron infusion (Visit 1) and after 2 months of treatment (Visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.