Iron Sucrose in Patients With Iron Deficiency and POTS

Mayo Clinic

Status and phase: Withdrawn; Phase 2

Conditions: Iron-deficiency; Postural Orthostatic Tachycardia Syndrome

Treatments: Drug: Sucrose; Diagnostic Test: Tilt Table Test; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04855266

21-000488

Details and patient eligibility

About

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).

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Iron Sucrose Group

Experimental group

Description:

Subjects will receive intravenous iron sucrose during a tilt table test

Treatment:

Diagnostic Test: Tilt Table Test

Drug: Sucrose

Placebo Group

Placebo Comparator group

Description:

Subjects will receive intravenous placebo during a tilt table test

Treatment:

Diagnostic Test: Tilt Table Test

Drug: Placebo