Iron Sucrose in Patients With Iron Deficiency and POTS

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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 patients with Postural Orthostatic Tachycardia syndrome (POTS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Ferric Oxide, Saccharated

Criteria

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