Status:
RECRUITING
Restoring Iron Deficiency in POTS
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Dysautonomia International
Conditions:
POTS - Postural Orthostatic Tachycardia Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
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 stu...
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 tre...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07197905
Start Date
November 24 2025
End Date
December 1 2026
Last Update
December 11 2025
Active Locations (1)
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1
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232