Restoring Iron Deficiency in POTS

NCT07197905 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 250671
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

POTS - Postural Orthostatic Tachycardia Syndrome

Keywords

Postural Tachycardia Syndrome; Iron Deficiency

Outcome Measures

Primary Outcomes (1)

• Orthostatic tachycardia

  Orthostatic tachycardia, defined as the difference between upright and supine heart rates, will be assessed during a 10-minute head-up tilt test.

  Orthostatic tachycardia will be assessed before iron infusion (Visit 1) and after 2 months of treatment (Visit 2)

Study Arms (1)

Intravenous Iron Infusion

EXPERIMENTAL

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

Drug: Intravenous iron

Interventions

Intravenous iron DRUG

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

Intravenous Iron Infusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Dysautonomia International: collaborator

Study Sites (1)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Iron Deficiencies

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Italo Biaggioni, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Orillion, BSN, RN

CONTACT

615-875-9405; autonomics@vumc.org

Luis E Okamoto, MD

CONTACT

615-936-6119; autonomics@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pharmacology

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: September 30, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)