Iron Sucrose in Patients With Iron Deficiency and POTS

Phase 2

Withdrawn

• Conditions: Postural Orthostatic Tachycardia Syndrome; Iron-deficiency
• Interventions: Drug: Placebo; Drug: Sucrose; Diagnostic Test: Tilt Table Test

• Registration Number: NCT04855266
• Lead Sponsor: Mayo Clinic

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 patients with Postural Orthostatic Tachycardia syndrome (POTS).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-22
• Primary Completion: 2023-05
• Study Completion: 2023-05
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Subjects will receive intravenous placebo during a tilt table test
Iron Sucrose Group	Tilt Table Test	Subjects will receive intravenous iron sucrose during a tilt table test
Placebo Group	Tilt Table Test	Subjects will receive intravenous placebo during a tilt table test
Iron Sucrose Group	Sucrose	Subjects will receive intravenous iron sucrose during a tilt table test

Primary Outcome Measures

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