Back to resultsShort-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
Primary Purpose
Heart Failure, Iron Deficiency Anemia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sodium ferric gluconate
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- University of North Carolina Hospitals & Clinics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sodium ferric gluconate
Arm Description
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.
Outcomes
Primary Outcome Measures
Serum Hemoglobin Concentration
Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion
Secondary Outcome Measures
Transferrin Saturation
Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion
Serum Ferritin Level
Change in serum ferritin level compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion
Full Information
NCT ID
NCT01925703
First Posted
May 30, 2013
Last Updated
August 12, 2015
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT01925703
Brief Title
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
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Iron Deficiency Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium ferric gluconate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium ferric gluconate
Other Intervention Name(s)
Ferrlecit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum Hemoglobin Concentration
Description
Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion
Time Frame
Baseline and at follow-up within 1-4 weeks
Secondary Outcome Measure Information:
Title
Transferrin Saturation
Description
Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion
Time Frame
Baseline and at follow-up within 1-4 weeks
Title
Serum Ferritin Level
Description
Change in serum ferritin level compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion
Time Frame
Baseline and at follow-up within 1-4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Ellen Rodgers, PharmD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina Hospitals & Clinics
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
We'll reach out to this number within 24 hrs