Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT01925703
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01925703
Study Brief:
Protocol Section:
NCT01925703