Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925703
• Other study ID #: 11-0551
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2013
• Last updated: August 12, 2015
• Start date: April 2011
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Heart Failure
• Iron Deficiency Anemia

Intervention

Drug:
• Sodium ferric gluconate
Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.

Locations

Country	Name	City	State
United States	University of North Carolina Hospitals & Clinics	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Hemoglobin Concentration	Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion	Baseline and at follow-up within 1-4 weeks	No
Secondary	Transferrin Saturation	Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion	Baseline and at follow-up within 1-4 weeks	No
Secondary	Serum Ferritin Level	Change in serum ferritin level compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion	Baseline and at follow-up within 1-4 weeks	No