Iron Sucrose in Patients With Iron Deficiency and POTS

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)

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).

Study Overview

• Status: Withdrawn
• Conditions: Iron-deficiency; Postural Orthostatic Tachycardia Syndrome
• Intervention / Treatment: Drug: Sucrose; Diagnostic test: Tilt Table Test; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iron Sucrose Group; Subjects will receive intravenous iron sucrose during a tilt table test	Drug: Sucrose; 5 mg/kg of intravenous iron sucrose (maximum dose of 200 mg). Iron sucrose will be diluted; Other Names: Venofer; Diagnostic test: Tilt Table Test; 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.
Placebo Comparator: Placebo Group; Subjects will receive intravenous placebo during a tilt table test	Diagnostic test: Tilt Table Test; 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.; Drug: Placebo; Normal saline (NaCl 0.9%) 5 mL/kg (maximum volume 210 mL)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kamal Shouman, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2021
• Primary Completion (Estimated): May 1, 2023
• Study Completion (Estimated): May 1, 2023

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Nervous System Diseases; Disease; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Syndrome; Anemia, Iron-Deficiency; Tachycardia; Postural Orthostatic Tachycardia Syndrome; Iron Deficiencies; Hematinics; Ferric Oxide, Saccharated
• Other Study ID Numbers: 21-000488

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No