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临床试验/NCT01758627
NCT01758627已完成不适用

The Role of Peritoneal Dialysis in Patients With Refractory Heart Failure and Chronic Kidney Disease

Yonsei University1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
Changes of New York Heart Association (NYHA) functional class

研究概览

简要总结

In patients with advanced heart failure (HF), systemic congestion is the main indication for hospitalization. Recent evidence has highlighted the role of fluid retention in the pathogenesis of renal dysfunction and subsequent diuretic resistance. Previous kidney disease, diuretic resistance, and progression of renal dysfunction often coexist in patients with HF and persistent volume overload. This clinical presentation represents the most extreme feature of the cardio-renal syndrome. However, available therapeutic options for this ominous condition are scarce and limited. Indeed, there are no data from randomized control trials using pharmacological interventions that support the beneficial effect on survival. Interestingly, intermittent ultrafiltration has recently emerged as an alternative therapeutic option for reducing volume overload in patients with refractory HF. Current literature suggests that it has potential advantages over standard medical treatment particularly in acute stages of HF. Among ultrafiltration methods, peritoneal dialysis (PD) has been preferred as an additional resource for the treatment of advanced congestive heart failure (CHF) compared with hemodialysis because it can provide a more physiological and continuous ultrafiltration. In fact, several studies showed that use of PD improved clinical functional class and hemodynamic parameters and reduced hospitalization rates in patients with CHF. Nevertheless, most studies were limited by retrospective analyses of small sample size, prospective observational design with no control group, or inclusion of patients with end-stage renal failure. Therefore, well-designed prospective randomized controlled studies are mandatory to confirm the effects of PD in these patients.

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
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least two non-planned admissions for acute heart failure (AHF), the last episode being in the past 6 months
  • New York Heart Association (NYHA) functional class III/IV and left ventricular ejection fraction (LVEF) less than 40%
  • Persistent congestion despite optimal loop diuretic therapy
  • Presence of renal dysfunction [estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2] documented at least once in the last 6 months

排除标准

  • < 20 years of age
  • Unsuitable for PD (patients with major abdominal wall defects)
  • Allergic to starch or other contraindication to icodextrin (5) End-stage renal disease (eGFR < 10 ml/min/1.73 m2) requring dialysis treatment

研究组 & 干预措施

Conventional treatment group

Experimental

medical treatment such as diuretics

干预措施: Peritoneal dialysis (PD) (Drug)

结局指标

主要结局

Changes of New York Heart Association (NYHA) functional class

时间窗: at 0 (±1 week), 12 (±1 week), and 24 (±1 week) weeks)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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