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
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 StatesSite Not Available

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