A Study to Evaluate the Effectiveness of Intravenous Iron Sucrose in Patients with Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kamal Shouman, M.D.

Open for enrollment

Contact information:

Tonette Gehrking CAP

(507) 284-0336

adc.research@mayo.edu

More information

Publications

Publications are currently not available
.

Mayo Clinic Footer