Clinical trial NCT01925703: Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
Official title: Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Iron Deficiency Anemia
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Serum Hemoglobin Concentration
timeFrame: Baseline and at follow-up within 1-4 weeks
Secondary outcomes:
measure: Transferrin Saturation
timeFrame: Baseline and at follow-up within 1-4 weeks
measure: Serum Ferritin Level
timeFrame: Baseline and at follow-up within 1-4 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals & Clinics
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jo Ellen Rodgers, PharmD
role: PRINCIPAL_INVESTIGATOR
References: