A Randomized Clinical Trial of Intravenous Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,500
- 主要终点
- Number of patients with heart failure hospital admission or cardiovascular death
研究概览
简要总结
The INERTIA trial is a multicenter double-blinded randomized trial of intravenous iron supplementation in patients with severe aortic stenosis and iron deficiency undergoing TAVI or SAVR. The primary endpoint is the time to HF hospital admission or cardiovascular death. Secondary endpoints will assess quality of life indicators and functional capacity at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aortic stenosis
- •Enrolled for TAVI or SAVR procedures
- •Documented iron deficiency with either: Ferritin <100ug/L or Ferritin between 100-299ug/L and Transferrin Saturation < 20%.
排除标准
- •Use of packed red blood cells or whole blood in the past 3 months;
- •Use of erythropoietin-stimulating agent or IV iron in the past 3 months;
- •Use of oral or IV iron (>100mg/day) in the past 3 months;
- •Haemoglobin (Hb) levels > 15g/dL or < 8g/dL;
- •Active cancer;
- •Infection requiring antibiotic treatment at the time of first scheduled dose;
- •Any known contraindication to study intervention
研究组 & 干预措施
Iron supplementation
Intravenous ferric carboxymaltose will be administered according to weight and hemoglobin values at randomization as follows:
2-4 weeks before valve intervention On the day of admission to valve intervention (if determined by dose calculation, otherwise placebo) 12 weeks after valve intervention (if iron deficiency persists, otherwise placebo)
干预措施: Ferric carboxymaltose (Drug)
Placebo
Intravenous 0.9% NaCl (placebo) will be administered as follows:
2-4 weeks before valve intervention On the day of admission to valve intervention 12 weeks after valve intervention
干预措施: Ferric carboxymaltose (Drug)
结局指标
主要结局
Number of patients with heart failure hospital admission or cardiovascular death
时间窗: up to 52 weeks
Analyzed as time-to-event
次要结局
- Patient Global Assessment(6 months post-TAVI or SAVR)
- EQ-5D-5L(6 months post-TAVI or SAVR)
- Total number of allogeneic RBC units received(30 days post-TAVI or SAVR)
- Kansas City Cardiomyopathy Questionnaire(6 months post-TAVI or SAVR)
- Walking distance(6 months post-TAVI or SAVR)
研究者
Afonso Félix de Oliveira
Principal Investigator
Hospital de Santa Cruz, Portugal