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Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure

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ClinicalTrials.gov Identifier: NCT01925703
Recruitment Status : Completed
First Posted : August 20, 2013
Results First Posted : August 10, 2015
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
Intravenous iron replacement has been shown to benefit patients with heart failure and iron deficiency, but the weekly outpatient regimens studied to date are impractical for many patients. Our purpose is to evaluate the short-term effects and safety of an accelerated intravenous iron regimen in hospitalized patients with these two conditions.

Condition or disease Intervention/treatment Phase
Heart Failure Iron Deficiency Anemia Drug: Sodium ferric gluconate Phase 4

Detailed Description:
The purpose of this pilot investigation is to evaluate the short-term hematologic effects and safety of an accelerated intravenous iron regimen in patients with heart failure and iron deficiency. Recent investigations have demonstrated improved clinical outcomes with the use of intravenous iron therapy in this patient population, but a weekly regimen administered to ambulatory patients may be inconvenient, impractical, and associated with less than optimal adherence rates for many patients, especially those with reduced functional capacity. The heart failure population is characterized by frequent hospitalizations, which would make an accelerated inpatient regimen a convenient and attractive option for improving heart failure symptoms, exercise tolerance, and quality of life. Accelerated regimens have been demonstrated as being both safe and effective in other patient populations, but no studies to date have evaluated this strategy in hospitalized patients with heart failure.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
Study Start Date : April 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013


Arm Intervention/treatment
Experimental: Sodium ferric gluconate
Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
Drug: Sodium ferric gluconate
Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
Other Name: Ferrlecit




Primary Outcome Measures :
  1. Serum Hemoglobin Concentration [ Time Frame: Baseline and at follow-up within 1-4 weeks ]
    Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion


Secondary Outcome Measures :
  1. Transferrin Saturation [ Time Frame: Baseline and at follow-up within 1-4 weeks ]
    Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion

  2. Serum Ferritin Level [ Time Frame: Baseline and at follow-up within 1-4 weeks ]
    Change in serum ferritin level compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Admission to the general cardiology or heart failure services and under the care of a cardiologist at the study institution
  • New York Heart Association Class II-IV heart failure
  • Ejection fraction < 40%
  • Serum hemoglobin < 12.0 g/dL
  • Ferritin < 100 ng/mL or 100-300 ng/mL with transferrin saturation (TSAT) < 20%
  • Patients deemed by an attending physician to require intravenous iron therapy based on previous attempts to correct iron deficiency or other patient-specific circumstances

Exclusion Criteria:

  • Anemia of other known etiology (e.g., malignancy, malabsorption syndromes)
  • Use of iron or erythropoietin-stimulating agents within previous 12 weeks
  • Blood transfusion within previous 12 weeks; additionally, if patients receive blood transfusions during the study period, they will remain in the safety analysis but will be excluded from efficacy analysis
  • Active bleeding
  • Known infection at admission
  • Immunosuppressant therapy
  • Renal replacement therapy
  • Known pregnancy
  • Any other criteria deemed by the attending physician to warrant exclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925703


Locations
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United States, North Carolina
University of North Carolina Hospitals & Clinics
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Jo Ellen Rodgers, PharmD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01925703     History of Changes
Other Study ID Numbers: 11-0551
First Posted: August 20, 2013    Key Record Dates
Results First Posted: August 10, 2015
Last Update Posted: August 25, 2015
Last Verified: May 2014
Additional relevant MeSH terms:
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Ferric gluconate
Ferric Compounds
Heart Failure
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Hematinics