Iron Sucrose in Patients With Iron Deficiency and POTS

NCT04855266 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 21-000488
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Iron-deficiency; Postural Orthostatic Tachycardia Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Iron Sucrose Group

EXPERIMENTAL

Subjects will receive intravenous iron sucrose during a tilt table test

Drug: Sucrose; Diagnostic Test: Tilt Table Test

Placebo Group

PLACEBO COMPARATOR

Subjects will receive intravenous placebo during a tilt table test

Drug: Placebo; Diagnostic Test: Tilt Table Test

Interventions

Sucrose DRUG

5 mg/kg of intravenous iron sucrose (maximum dose of 200 mg). Iron sucrose will be diluted

Also known as: Venofer

Iron Sucrose Group

Placebo DRUG

Normal saline (NaCl 0.9%) 5 mL/kg (maximum volume 210 mL)

Placebo Group

Tilt Table Test DIAGNOSTIC_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.

Iron Sucrose Group; Placebo Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Postural Orthostatic Tachycardia Syndrome

Interventions

Sucrose; Ferric Oxide, Saccharated; Tilt-Table Test

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kamal Shouman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: April 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06