Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Serum Hemoglobin Concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sodium ferric gluconate (Drug)
结局指标
主要结局
Serum Hemoglobin Concentration
时间窗: 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
次要结局
- Serum Ferritin Level(Baseline and at follow-up within 1-4 weeks)
- Transferrin Saturation(Baseline and at follow-up within 1-4 weeks)