NCT07197905 Restoring Iron Deficiency in POTS
| NCT ID | NCT07197905 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | POTS - Postural Orthostatic Tachycardia Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-11-24 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 12 participants in total. It began in 2025-11-24 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 cell volume and improve POTS symptoms.
Eligibility Criteria
Inclusion Criteria * 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. Exclusion Criteria * 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.
Contact & Investigator
Italo Biaggioni, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT07197905 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying POTS - Postural Orthostatic Tachycardia Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07197905 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07197905 currently recruiting?
Yes, NCT07197905 is actively recruiting participants. Contact the research team at autonomics@vumc.org for enrollment information.
Where is the NCT07197905 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT07197905 clinical trial?
NCT07197905 is sponsored by Vanderbilt University Medical Center. The principal investigator is Italo Biaggioni, MD at Vanderbilt University Medical Center. The trial plans to enroll 12 participants.