Restore iron levels in POTS

Restoring Iron Deficiency to Expand Blood Volume and Improve POTS

This trial will give intravenous iron to adults with POTS who have low ferritin to see if it raises red blood cell volume and eases symptoms.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Vanderbilt University Medical Center (other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT07197905 on ClinicalTrials.gov

What this trial studies

Adults with confirmed POTS and low ferritin will have a baseline visit with medical history, physical exam, questionnaires, bloodwork, blood volume measurements, autonomic tests, and an activity monitor. Participants will receive an intravenous iron infusion and return about two months later for repeat bloodwork, blood volume measurement, autonomic testing, and symptom questionnaires. The study focuses on whether correcting iron deficiency increases red blood cell volume and improves orthostatic symptoms. It is a phase 2 pilot conducted at a single center.

Who should consider this trial

Good fit: Adults 18–45 with a confirmed POTS diagnosis, serum ferritin under 50 ng/mL, no other medical explanation for orthostatic tachycardia, and who can attend Vanderbilt visits are ideal candidates.

Not a fit: People without low ferritin, with other causes of their tachycardia, who are pregnant, bed- or chair-bound, or who have recent IV iron hypersensitivity are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, correcting iron deficiency could increase red blood cell volume and reduce POTS symptoms like rapid heart rate and fatigue.

How similar studies have performed: Some small studies in iron-deficient patients show improvements in fatigue and hematologic measures after iron repletion, but using IV iron specifically to treat POTS symptoms is relatively novel and under-studied.

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.

Where this trial is running

Nashville, Tennessee

• Autonomic Dysfunction Center/ Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)

Study contacts

• Principal investigator: Italo Biaggioni, MD — Vanderbilt University Medical Center
• Study coordinator: Megan Orillion, BSN, RN

Conditions: POTS - Postural Orthostatic Tachycardia Syndrome, Postural Tachycardia Syndrome, Iron Deficiency