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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Iron Deficiency Anemia
• Intervention / Treatment: Drug: Sodium ferric gluconate

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina Hospitals & Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Ferrlecit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Hemoglobin Concentration	Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion	Baseline and at follow-up within 1-4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transferrin Saturation	Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion	Baseline and at follow-up within 1-4 weeks
Serum Ferritin Level	Change in serum ferritin level compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion	Baseline and at follow-up within 1-4 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Jo Ellen Rodgers, PharmD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 30, 2013
• First Submitted That Met QC Criteria: August 16, 2013
• First Posted (Estimate): August 20, 2013

Study Record Updates

• Last Update Posted (Estimate): August 25, 2015
• Last Update Submitted That Met QC Criteria: August 12, 2015
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Heart Failure; Anemia, Iron-Deficiency; Hematinics; Ferric gluconate
• Other Study ID Numbers: 11-0551