Intravenous Iron for POTS
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.12345Why 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.13678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous iron infusion to improve POTS symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intravenous Iron
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Dysautonomia International
Collaborator