POTS - Postural Orthostatic Tachycardia Syndrome
Conditions
Keywords
Postural Tachycardia Syndrome, Iron Deficiency
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.
Detailed 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.
Interventions
DRUGIntravenous iron
The Intravenous iron infusion will be administered according to standard clinical care. The provider will choose the dosage and formulation of IV iron.
Sponsors
Dysautonomia International
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Orthostatic tachycardia | Orthostatic tachycardia will be assessed before iron infusion (Visit 1) and after 2 months of treatment (Visit 2) | Orthostatic tachycardia, defined as the difference between upright and supine heart rates, will be assessed during a 10-minute head-up tilt test. |
Countries
United States
Contacts
Primary ContactMegan Orillion, BSN, RN
Backup ContactLuis E Okamoto, MD
Outcome results
None listed