Heart Failure, Iron Deficiency Anemia
Conditions
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.
Interventions
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.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Hemoglobin Concentration | Baseline and at follow-up within 1-4 weeks | Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transferrin Saturation | Baseline and at follow-up within 1-4 weeks | Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion |
| Serum Ferritin Level | Baseline and at follow-up within 1-4 weeks | Change in serum ferritin level compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discharge prior to full iron repletion | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Sodium Ferric Gluconate |
|---|---|
| Age, Continuous | 58.9 years STANDARD_DEVIATION 12.8 |
| Body Mass Index | 33.9 kilograms per meter squared STANDARD_DEVIATION 9.5 |
| Ejection Fraction | 20.2 percent STANDARD_DEVIATION 8.4 |
| Ferritin Concentration | 86.4 nanograms per milliliter STANDARD_DEVIATION 61.4 |
| Hemoglobin Concentration | 10.6 grams per deciliter STANDARD_DEVIATION 1.4 |
| NYHA Heart Failure Class Class I | 0 participants |
| NYHA Heart Failure Class Class II | 0 participants |
| NYHA Heart Failure Class Class III | 7 participants |
| NYHA Heart Failure Class Class IV | 6 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 13 participants |
| Serum Creatinine Concentration | 1.2 milligrams per deciliter STANDARD_DEVIATION 0.4 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
| Transferrin Saturation | 11.7 percentage of transferrin saturation STANDARD_DEVIATION 4.6 |
| Weight | 94.9 kilograms STANDARD_DEVIATION 25 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 13 |
| serious Total, serious adverse events | 1 / 13 |
Outcome results
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
Time frame: Baseline and at follow-up within 1-4 weeks
Population: All patients who achieved complete iron repletion for whom follow up data were available.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sodium Ferric Gluconate | Serum Hemoglobin Concentration | 1.2 grams per deciliter |
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
Time frame: Baseline and at follow-up within 1-4 weeks
Population: All participants who achieved complete iron repletion for whom follow up data were available.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sodium Ferric Gluconate | Serum Ferritin Level | 364.2 nanograms per milliliter |
Secondary
Transferrin Saturation
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
Population: All patients who achieved complete iron repletion for whom follow-up data were available.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sodium Ferric Gluconate | Transferrin Saturation | 10.5 Percentage of transferrin saturation |