Iron Sucrose in Patients With Iron Deficiency and POTS

Last updated: June 12, 2023
Sponsor: Mayo Clinic
Overall Status: Trial Not Available

Phase

2

Condition

Fast Heart Rate (Tachycardia)

Dysrhythmia

Heart Defect

Treatment

Sucrose

Tilt Table Test

Placebo

Clinical Study ID

NCT04855266
21-000488
  • Ages > 12
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients (age 12 to years and older) with chronic (>3 months) symptoms of orthostaticintolerance, 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 withhemoglobin no less than 1 gm/dL below the normal reference range as defined for ageand 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

Exclusion Criteria:

  • Orthostatic hypotension (decrease of systolic BP>30 mmHg and/or diastolic BP>15mmHgwithin 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 affectautonomic function
  • Concomitant therapy with anticholinergic, alpha-adrenergic antagonists,beta-adrenergic antagonists or other medications which could interfere with autonomictesting. Patients may participate if the potentially interfering medication is heldfor 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 ironpreparation

Study Design

Treatment Group(s): 3
Primary Treatment: Sucrose
Phase: 2
Study Start date:
April 01, 2021
Estimated Completion Date:
May 31, 2023

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.