Iron Sucrose in Patients With Iron Deficiency and POTS

Iron-deficiency Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04855266
• Other study ID #: 21-000488
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2021
• Est. completion date: May 2023

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency
• Postural Orthostatic Tachycardia Syndrome
• Syndrome
• Tachycardia

Intervention

Drug:
• Sucrose
5 mg/kg of intravenous iron sucrose (maximum dose of 200 mg). Iron sucrose will be diluted
• Placebo
Normal saline (NaCl 0.9%) 5 mL/kg (maximum volume 210 mL)

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in postural heart rate increase	Heart rate change during tilt table test measured in beats per minute	Baseline, 7 days

External Links

•   Mayo Clinic Clinical Trials