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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium ferric gluconate | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium ferric gluconate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Serum Ferritin Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jo Ellen Rodgers, PharmD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Hospitals & Clinics | Chapel Hill | North Carolina | 27514 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All patients who achieved complete iron repletion for whom follow up data were available. | Posted | Mean | 95% Confidence Interval | grams per deciliter | Baseline and at follow-up within 1-4 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinical Deterioration | General disorders | Non-systematic Assessment | Patient was withdrawn from study after two of the four study drug doses were administered at the discretion of the treating physician. Reason for withdrawal was clinical deterioration secondary to hypovolemia and aggressive vasodilator titration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brent N. Reed | University of Maryland School of Pharmacy, Department of Pharmacy Practice and Science | breed@rx.umaryland.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
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| ID | Term |
|---|---|
| C035552 | ferric gluconate |
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|
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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Body Mass Index | Mean | Standard Deviation | kilograms per meter squared |
|
| NYHA Heart Failure Class | Number | participants |
|
| Ejection Fraction | Mean | Standard Deviation | percent |
|
| Hemoglobin Concentration | Mean | Standard Deviation | grams per deciliter |
|
| Ferritin Concentration | Mean | Standard Deviation | nanograms per milliliter |
|
| Transferrin Saturation | Mean | Standard Deviation | percentage of transferrin saturation |
|
| Serum Creatinine Concentration | Mean | Standard Deviation | milligrams per deciliter |
|
| Participants |
|
|
| Secondary | Transferrin Saturation | Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion | All patients who achieved complete iron repletion for whom follow-up data were available. | Posted | Mean | 95% Confidence Interval | Percentage of transferrin saturation | Baseline and at follow-up within 1-4 weeks |
|
|
|
| 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 | All participants who achieved complete iron repletion for whom follow up data were available. | Posted | Mean | 95% Confidence Interval | nanograms per milliliter | Baseline and at follow-up within 1-4 weeks |
|
|
|
| 1 |
| 13 |
| 11 |
| 13 |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| injection site itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| injection site discomfort | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| thrombophlebitis | Vascular disorders | Non-systematic Assessment |
|
| cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| leg cramps | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bladder discomfort | Renal and urinary disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| chills | General disorders | Non-systematic Assessment |
|
| melena | Gastrointestinal disorders | Non-systematic Assessment |
|
| hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |