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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Heart Failure, Iron Deficiency Anemia

Intervention / Treatment
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* Drug: Sodium ferric gluconate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium ferric gluconate<br>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<br>* 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.<br>* Other names: Ferrlecit;|

What is the study measuring?
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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 |