Iron Sucrose in Patients With Iron Deficiency and POTS

• ClinicalTrials.gov Identifier: NCT04855266
• Recruitment Status: Recruiting
• First Posted: April 22, 2021
• Last Update Posted: July 7, 2021
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Kamal Shouman, Mayo Clinic

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Iron-deficiency; Postural Orthostatic Tachycardia Syndrome	Drug: Sucrose; Drug: Placebo; Diagnostic Test: Tilt Table Test	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: June 1, 2021
• Estimated Primary Completion Date: May 2023
• Estimated Study Completion Date: May 2023

Arms and Interventions

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 Name: 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	Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in autonomic dysfunction symptoms [ Time Frame: 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
2. Change in postural heart rate increase [ Time Frame: Baseline, 7 days ]
   Heart rate change during tilt table test measured in beats per minute

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Tonette Gehrking 507-284-0336 adc.research@mayo.edu

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Kamal Shouman, MD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Kamal Shouman, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04855266
• Other Study ID Numbers: 21-000488
• First Posted: April 22, 2021
• Last Update Posted: July 7, 2021
• Last Verified: July 2021

• 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

Additional relevant MeSH terms:

Postural Orthostatic Tachycardia Syndrome; Tachycardia; Anemia, Iron-Deficiency; Syndrome; Disease; Pathologic Processes; Anemia, Hypochromic; Anemia; Hematologic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Ferric Oxide, Saccharated; Hematinics