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Recruiting NCT07197905

Restoring Iron Deficiency in POTS

Phase II Interventional POTS - Postural Orthostatic Tachycardia Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravenous iron.
Who it may be relevant to
Registry conditions: POTS - Postural Orthostatic Tachycardia Syndrome. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Restoring Iron Deficiency to Expand Blood Volume and Improve POTS

Overview

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.

Interventions

  • Drug Intravenous iron
    The Intravenous iron infusion will be administered according to standard clinical care. The provider will choose the dosage and formulation of IV iron.

Primary outcome measures

  • Orthostatic tachycardia [Time frame: Orthostatic tachycardia will be assessed before iron infusion (Visit 1) and after 2 months of treatment (Visit 2)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Autonomic Dysfunction Center/ Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT07197905 · 250671

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗