Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
Completed · Phase 4
Conditions studied: Heart Failure, Iron Deficiency Anemia
In brief
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.
Key facts
- Study ID
- NCT01925703
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 13
- Starts
- 2011-04-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2015-08-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of North Carolina Hospitals & Clinics — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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