Phase 4
Completed N=13
Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
Source: ClinicalTrials.gov NCT01925703 ↗Enrolled (actual)
13
Serious AEs
7.7%
Results posted
Aug 2015
Primary outcomePrimary: Serum Hemoglobin Concentration — 1.2 grams per deciliter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Hemoglobin Concentration |
1.2 | — |
| SECONDARY Transferrin Saturation |
10.5 | — |
| SECONDARY Serum Ferritin Level |
364.2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01925703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.