Oral Iron for the Management of Iron Deficiency Anemia in SGLT2i-Treated Heart Failure Patients: A Prospective Analysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin Levels
研究概览
简要总结
People with heart failure often have anemia caused by low iron levels. Ongoing inflammation in heart failure can impair iron absorption, making oral iron therapy less effective.
Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are medications used to treat heart failure. In addition to their cardiovascular benefits, these drugs may improve iron metabolism and support red blood cell production.
This study evaluates whether patients with heart failure and iron deficiency anemia who are receiving SGLT2i therapy respond to treatment with oral iron. Participants receive oral iron for three to four months, followed by a short period without treatment. Blood tests are used to assess changes in hemoglobin levels.
The objective of this study is to determine whether treatment with SGLT2i enhances the response to oral iron in patients with heart failure and iron deficiency anemia.
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
- •1) Previous diagnosis of heart failure, irrespective of ejection fraction;
- •2) Iron deficiency anemia defined as hemoglobin <13 g/dL in men or <12 g/dL in women, with transferrin saturation (TSAT) <20%;
- •3) Ongoing treatment with an SGLT2 inhibitor (SGLT2i) for more than 3 months at the time of enrollment.
排除标准
- •1) Concomitant use of intravenous iron, erythropoiesis-stimulating agents (ESAs), red blood cell transfusions, or other blood products within 3 months before enrollment;
- •2) Severe anemia, defined as hemoglobin <7 g/dL or clinical indication for transfusion;
- •3) Relevant intercurrent illnesses associated with inflammatory response (e.g., infection, acute kidney injury, or acute decompensated heart failure) within 3 months before enrollment;
- •4) Confirmed or suspected active bleeding;
- •5) End-stage renal disease or receiving renal replacement therapy;
- •6) History of any type of active cancer;
- •7) History of solid or non-solid organ transplantation.
结局指标
主要结局
Change in Hemoglobin Levels
时间窗: Baseline, 3-4 months, and 5-6 months
Change from baseline in hemoglobin levels measured by laboratory blood tests
次要结局
- Change in Hematocrit(Baseline, 3-4 months, and 5-6 months)
- Change in Transferrin Saturation(Baseline, 3-4 months, and 5-6 months)
- Change in Serum Iron(Baseline, 3-4 months, and 5-6 months)
- Change in Ferritin(Baseline, 3-4 months, and 5-6 months)
- Change in Total Iron-Binding Capacity (TIBC)(Baseline, 3-4 months, and 5-6 months)