Iron Sucrose in Patients With Iron Deficiency and POTS

Study Overview
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Brief Summary
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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 patients with Postural Orthostatic Tachycardia syndrome (POTS).

Official Title
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A Randomized, Controlled, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Intravenous Iron Sucrose in Patients With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)

Conditions
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Iron-deficiency, Postural Orthostatic Tachycardia Syndrome

Intervention / Treatment
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* Drug: Sucrose
* Drug: Placebo
* Diagnostic Test: Tilt Table Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron Sucrose Group<br>Subjects will receive intravenous iron sucrose during a tilt table test | Drug: Sucrose<br>* 5 mg/kg of intravenous iron sucrose (maximum dose of 200 mg). Iron sucrose will be diluted<br>* Other names: Venofer;Diagnostic Test: Tilt Table Test<br>* A table that adjusts the body position from horizontal to vertical to simulate standing up. Heart rate and blood pressure are monitored throughout the test.<br>|
| Placebo Comparator: Placebo Group<br>Subjects will receive intravenous placebo during a tilt table test | Drug: Placebo<br>* Normal saline (NaCl 0.9%) 5 mL/kg (maximum volume 210 mL)<br>Diagnostic Test: Tilt Table Test<br>* A table that adjusts the body position from horizontal to vertical to simulate standing up. Heart rate and blood pressure are monitored throughout the test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in autonomic dysfunction symptoms | Measured using the self-reported Composite Autonomic Symptom Score (COMPASS) questionnaire that asks 31 questions regarding symptoms of autonomic dysfunction | Baseline, 7 days, 6 months | 
| Change in postural heart rate increase | Heart rate change during tilt table test measured in beats per minute | Baseline, 7 days |