Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
| Status: | Completed |
|---|---|
| Conditions: | Iron Deficiency Anemia, Cardiology, Anemia, Anemia |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2011 |
| End Date: | December 2013 |
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.
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.
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.
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.
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
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