Restoring Iron Deficiency in POTS

Vanderbilt University Medical Center

Status and phase: Enrolling; Phase 2

Conditions: POTS - Postural Orthostatic Tachycardia Syndrome

Treatments: Drug: Intravenous iron

Study type: Interventional

Funder types: Other

Identifiers

NCT07197905

250671

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Intravenous Iron Infusion

Experimental group

Description:

The Intravenous iron infusion will be administered according to standard clinical care.

Treatment:

Drug: Intravenous iron