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New treatment option for POTS - Postural Orthostatic Tachycardia Syndrome
Official title Restoring Iron Deficiency in POTS
ClinicalTrials.gov ID: NCT07197905
What this study is testing
What is Intravenous iron?
Intravenous iron is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pots - postural orthostatic tachycardia syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join 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...
- 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...
You likely can't join 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.