Status:
WITHDRAWN
Iron Sucrose in Patients With Iron Deficiency and POTS
Lead Sponsor:
Mayo Clinic
Conditions:
Iron-deficiency
Postural Orthostatic Tachycardia Syndrome
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in patie...
Eligibility Criteria
Inclusion
- Patients (age 12 to years and older) with chronic (\>3 months) symptoms of orthostatic intolerance, including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and heart palpitations.
- Symptomatic orthostatic heart rate increment ≥30 bpm if \>19 years old or ≥40 bpm if \<19 years old during a 10 minute 70 degree head up tilt study
- Presence of non-anemic iron deficiency, defined as serum ferritin levels \<20 ug/L with hemoglobin no less than 1 gm/dL below the normal reference range as defined for age and gender
- Consent obtained from responsible guardian AND from subjects, 12-17 years of age
- Consent obtained for subjects 18 years of age and older
Exclusion
- Orthostatic hypotension (decrease of systolic BP\>30 mmHg and/or diastolic BP\>15mmHg within 3 minutes of 70 degree head up tilt study)
- Pregnant or lactating females
- The presence of failure of other organ systems or systemic illness that can affect autonomic function
- Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study
- Laboratory evidence of anemia or iron overload
- Personal history of hematochromatosis or first degree relative with hematochromatosis
- Known sensitivity to Venofer® (iron sucrose injection, USP) or other intravenous iron preparation
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04855266
Start Date
April 1 2021
End Date
May 1 2023
Last Update
June 13 2023
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