Intravenous Iron for POTS

Overseen By Luis E Okamoto, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Vanderbilt University Medical Center

Must not be taking: IV iron

Disqualifiers: Pregnancy, Bed-ridden, Active bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 2 months

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether intravenous iron can alleviate symptoms in people with POTS by increasing red blood cell levels. POTS, or postural orthostatic tachycardia syndrome, causes the heart rate to rise upon standing, leading to dizziness and fatigue. The trial targets individuals with low iron storage, which may contribute to these symptoms. Those experiencing POTS symptoms for at least three months and with low ferritin levels (a marker of iron storage) may find this trial suitable. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, potentially improving symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be able to hold POTS medications during study procedures. If you are on fludrocortisone, you can continue taking it as long as the dose remains the same.

Is there any evidence suggesting that intravenous iron is likely to be safe for humans?

Studies have shown that intravenous iron treatments are generally well-tolerated. Research on similar treatments for iron deficiency indicates that most people do not experience serious side effects. Common, mild side effects include headaches, nausea, or changes in taste, which usually resolve on their own.

In the past, individuals who received intravenous iron for conditions like iron deficiency reported improved symptoms and only mild, temporary discomfort. Although this treatment remains experimental for POTS, its use in other conditions suggests it is generally safe. This trial is in an early phase, focusing on testing safety and effectiveness in people with POTS. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for POTS?

Intravenous iron is unique because it offers a new approach to treating Postural Orthostatic Tachycardia Syndrome (POTS), a condition often managed with lifestyle changes, increased salt intake, and medications like beta-blockers or fludrocortisone. Unlike these standard treatments, intravenous iron directly addresses potential iron deficiency, which may be a contributing factor in some POTS cases. This method of delivering iron directly into the bloodstream ensures quicker absorption and potentially faster symptom relief. Researchers are excited about its potential to offer a more targeted and efficient treatment option for those struggling with this challenging condition.

What evidence suggests that intravenous iron might be an effective treatment for POTS?

Research has shown that intravenous iron can help people with POTS who have low iron levels. In one study, 67% of patients reported fewer POTS symptoms after receiving intravenous iron. This trial will provide intravenous iron infusions to participants, aiming to increase red blood cell volume, which may improve blood flow and reduce dizziness or a fast heartbeat when standing. Although more research is needed, these findings offer hope for better managing POTS symptoms with iron treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

Italo Biaggioni, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with Postural Orthostatic Tachycardia Syndrome (POTS) who also have low levels of ferritin, indicating iron deficiency. The study aims to include those who may benefit from increased red blood cell volume and symptom improvement.

Inclusion Criteria

Serum ferritin <50 ng/ml

I am between 18 and 45 years old.

I have been diagnosed with POTS and experience a significant heart rate increase upon standing.

Exclusion Criteria

History of hypersensitivity to any iron preparation or recent (within 6 months) treatment with any IV iron preparation

Pregnancy

I am unable to get out of bed or a chair by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous iron infusion to improve POTS symptoms

2 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intravenous Iron

Trial Overview

The intervention being tested is intravenous iron supplementation. The goal is to determine if this treatment can boost red blood cell volume and alleviate symptoms in POTS patients with low ferritin levels.

How Is the Trial Designed?

Group I: Intravenous Iron Infusion Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Dysautonomia International

Collaborator

Trials

6

Recruited

420+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07197905

NCT07197905 | Restoring Iron Deficiency in POTS

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

2.

mayo.edu

mayo.edu/research/clinical-trials/cls-20513940

A Study to Evaluate the Effectiveness of Intravenous Iron ...

This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11472415/

Management of Postural Orthostatic Tachycardia Syndrome in ...

The follow-up time ranged from 3 to 12 months. Of the patients included in the study, 67% of patients demonstrated a reduction in POTS symptoms.

4.

mayo.edu

mayo.edu/research/clinical-trials/diseases-conditions/postural-orthostatic-tachycardia-syndrome

Postural Orthostatic Tachycardia Syndrome Clinical Trials

The researchers expect pyridostigmine to improve tachycardia and stabilize blood pressure. A Study to Evaluate the Effectiveness of Intravenous Iron Sucrose ...

5.

cdek.pharmacy.purdue.edu

cdek.pharmacy.purdue.edu/trial/NCT04855266/

Trial | NCT04855266

This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8009458/

Postural orthostatic tachycardia syndrome (POTS) and ...

In this case series, we report the clinical features, diagnostic findings, treatment, and outcomes of 20 patients with new-onset autonomic ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04855266

Iron Sucrose in Patients With Iron Deficiency and POTS

This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting and ...

8.

ahajournals.org

ahajournals.org/doi/10.1161/circulationaha.112.144501

Postural Tachycardia Syndrome (POTS) | Circulation

Jacob et al16 have documented that midodrine reduces orthostatic tachycardia, but this effect is more modest than that of intravenous saline.