Symptomatic Improvement by Peritoneal Dialysis in Patients With End Stage Congestive Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of patients in NYHA class I, II, III, or IV as measure of quality of life
研究概览
简要总结
Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this condition and to find an optimal scheme.
Objective: To improve symptomatology in severe chronic failure patients. Study design: Open, parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin (Extraneal®) with standard medical therapy..
Study population: Patients with chronic refractory left ventricular congestive heart failure (LVEF < 30%, older than 18 years).
Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with icodextrin (Extraneal®).
Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive Heart Failure at 8 months after start of PD therapy. Burden of congestive heart failure: measured by reduction in unfavorable days (noted by patients in diaries and including days of hospitalization for CHF-deterioration and death).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Refractory Left Ventricular Congestive Heart Failure: LVEF < 30%
- •Diminished renal function: eGFR < 60 ml/min
- •Clinically volume overloaded (Dyspnoea (NYHA III-IV), edema, and/or ascites)
- •Hospitalization for CHF during the last 6 months
- •Patient is on optimal cardiologic medical therapy, which has been stable for more than 4 weeks
- •Suitable for PD
排除标准
- •Hypotension (SBP < 100 mmHg / MAP < 70) mmHg
- •Instable AP or recent (< 6 months) myocardial infarction.
- •Contraindications for PD (e.g. visual handicap, social)
- •Liver failure
- •COPD Gold class IV
- •Malignancy with life expectancy < 2 years
- •Non compliance
- •No informed consent
- •Poor mental health
研究组 & 干预措施
Standard Care
干预措施: icodextrin (Drug)
2 Icodextrin PD changes / day
干预措施: icodextrin (Drug)
1 Icodextrin PD change/day
干预措施: icodextrin (Drug)
结局指标
主要结局
Number of patients in NYHA class I, II, III, or IV as measure of quality of life
时间窗: 8 months
次要结局
- Quality of life measures(8 months)
研究者
Wilbert Martien Theodoor Janssen
MD PhD
Martini Hospital Groningen