To evaluate the impact of intravenous iron therapy in chronic kidney disease patients with heart failure A randomised controlled study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- 2)New York Heart Association (NYHA) functional class
研究概览
简要总结
This thesis explores the multifaceted role of iron in the complex interplay between chronic kidney disease (CKD) and chronic heart failure (CHF) through a randomized controlled trial (RCT). The study examines the consequences of iron deficiency in these conditions and investigates the potential of iron correction as a therapeutic strategy.
Specifically, it compares the effectiveness of intravenous (IV) iron isomaltoside 1 gm in one arm versus oral iron in the other arm.
By highlighting the critical role of iron in managing iron deficiency in patients with CKD and CHF, this research aims to enhance our understanding of the Cardio Renal Iron Deficiency (CRID) syndrome and pave the way for improved treatment modalities in this challenging clinical scenario.
It also compares exercise capacity and eGFR, EF post 3 months of drug administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 18 years left ventricular ejection fraction less than 50% NYHA class 2-4 CKD with estimated glomerular filtration rate less than 60 ml/min/1.73m2 Iron deficiency serum iron less than 800ug/ml and transferrin saturation less than 30% No previous exposure to intravenous iron therapy within last 3 months.
排除标准
- •Haematological criteria serum ferritin more than 800ug/ml Transferrin saturation more than 30 % CKD patients on maintenance hemodialysis Already received IV iron contraindications to iron therapy.
结局指标
主要结局
2)New York Heart Association (NYHA) functional class
时间窗: 12 weeks
1)Exercise capacity measured by the six-minute walk test (6MWT)
时间窗: 12 weeks
3)eGFR
时间窗: 12 weeks
4)MACE
时间窗: 12 weeks
次要结局
- •Hemoglobin concentration in CKD patients with anemia.(•Improvement in iron indices (e.g., serum ferritin, transferrin saturation))
研究者
Shrinath Mashale
Post graduate institute of medical education and research