Trial record 18 of 40 for:    Postural Tachycardia Syndrome

Iron Sucrose in Adolescents With Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)

This study is currently recruiting participants.
Verified October 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Amie E. Jones, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01978535
First received: June 7, 2013
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

This study is designed to investigate whether the treatment of non-anemic iron deficiency with intervenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in adolescents (age 12-18) with Postural Orthostatic Tachycardia Syndrome (POTS).


Condition Intervention Phase
Postural Orthostatic Tachycardia Syndrome
Drug: Iron infusion
Drug: Normal saline infusion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double Blinded Clinical Trial of Intravenous Iron Sucrose in Adolescents With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Cardiovascular indices-Intraval change in heart rate during 10-minute head up tilt table test [ Time Frame: 7 (+/- 2) days following intervention ] [ Designated as safety issue: No ]
    This study will assess whether a single infusion of iron sucrose will improve cardiovascular indices, specifically a reduction in the intraval of measured heart rate change, during a ten minute head up tilt, in adolescent subjects with POTS and non-anemic iron deficiency


Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iron infusion
Iron Sucrose (Venofer (R))
Drug: Iron infusion
5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg. Iron sucrose will be diluted to 1 mg of elemental iron in 1 mL of NaCl 0.9% with a maximum volume of 210 mL.
Other Names:
  • Iron sucrose
  • Venofer (TM)
Placebo Comparator: Normal saline infusion
Equal volume to intervention of normal saline
Drug: Normal saline infusion
Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
Other Names:
  • Normal saline
  • NaCl 0.9%

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • aged 12-18 years
  • chronic (>3 months)symptoms of orthostatic intolerance (including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and palpitations)
  • symptomatic orthostatic heart rate increase of greater than or equal to 40 beats per minute during a 10 minute 70 degree head up tilt study
  • presence of non-anemic iron deficiency, defined as serum ferritin level less than or equal to 12 ug/L with normal hemoglobin

Exclusion criteria

  • orthostatic hypotension within 3 minutes of 70 degree head up tilt
  • pregnant or lactating females
  • presence of other organ failure or systemic illness that can affect autonomic function
  • concurrent medication therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists unless medication is held for five half-lives prior to study
  • laboratory evidence of anemia or iron overload
  • personal history of hematochromatosis or first degree relative with hematochromatosis
  • known sensitivity to Venofer (TM) or other intravenous iron preparations
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01978535

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tonette Gehrking    507-284-4462      
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Amie Jones, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Amie E. Jones, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01978535     History of Changes
Other Study ID Numbers: 12-009963
Study First Received: June 7, 2013
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
POTS

Additional relevant MeSH terms:
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Anemia, Iron-Deficiency
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Ferric oxide, saccharated
Ferric Compounds
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014