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Restoring Iron Deficiency in POTS

This study is looking into whether giving intravenous iron (iron given directly into a vein) can help people with Postural Orthostatic Tachycardia Syndrome (POTS) who also have low ferritin levels. Ferritin is a protein that stores iron in your body. The study aims to see if intravenous iron can increase red blood cell volume and improve POTS symptoms. To join, you must be a woman between 18 and 45 years old with a POTS diagnosis. The main goal is to see if the iron treatment reduces orthostatic tachycardia (a fast heart rate when standing up) after two months. The study is currently unclear on its recruitment status and plans to enroll 12 participants.

Study design
This is an interventional pilot study planning to enroll 12 women. It is not specified if it is randomized or blinded.
What's involved
You would have a physical exam, medical history, questionnaires, bloodwork, blood volume measurements, autonomic function tests, and wear an activity monitor before and 2 months after receiving intravenous iron.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed two months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07197905

Restoring Iron Deficiency in POTS

Recruiting
PHASE2Ages 18–45InterventionalTreatment
Vanderbilt University Medical Center
~12 participants
Updated 2025-12-11 on ClinicalTrials.gov
What's tested:Intravenous iron

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Orthostatic tachycardia
Measured over Orthostatic tachycardia will be assessed before iron infusion (Visit 1) and after 2 months of treatment (Visit 2)

Conditions

POTS - Postural Orthostatic Tachycardia Syndrome

Explore related trials

Iron DeficiencyPostural Orthostatic Tachycardia SyndromeFerritin

NCT07197905

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Autonomic Dysfunction Center/ Vanderbilt University Medical Center

    Nashville, Tennesseeno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Italo Biaggioni, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Megan Orillion, BSN, RN
[email protected]
615-875-9405
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Orthostatic tachycardiaOrthostatic 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.