PD-HF: A Multi-centre Randomised Controlled Trial of Intermittent Peritoneal Dialysis With Icodextrin-based Solutions on Patients With Severe Heart Failure and Stage 3-4 Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- The primary end-point is a change of 25 metres walked
研究概览
简要总结
This trial is to establish whether ultrafiltration by peritoneal dialysis is a clinically effective treatment for patients with severe heart failure and moderate chronic kidney disease, thus improving quality of life and symptoms.
详细描述
The trial is a multi-centre, prospective, randomised, unblended, controlled trial of intermittent PD with a single daily exchange of icodextrin plus best standard care versus best standard care for the treatment of severe HF and moderate CKD. A second exchange with glucose based solution may be given, should it be required in the investigator's/clinician's opinion. Investigators will randomise 130 participants for 32 weeks with randomisation stratified by participating centre. Participants will be recruited from specialist-led outpatient HF services in 6 NHS trusts and be managed by both cardiologists and nephrologists.
PD catheter insertion will occur according to the participating centre's institutional protocol. Treatment begins 1 week after catheter insertion and consists of a single nightly exchange.
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
- •Severe heart failure (NYHA grade III or IV)
- •Chronic kidney disease stage 3-4
- •Fluid overload resistant to diuretics OR hospital admission for HF in last 6 months
- •Left ventricular ejection fraction ≤40% in last 2 years (moderate/severe)
- •Using optimal HF medication for ≥ 4 weeks including ACE-inhibitor (angiotensin-converting-enzyme inhibitor) OR angiotensin receptor blocker AND aldosterone antagonist AND beta-blocker unless intolerant and without dose change for ≥ 4 weeks
- •Appropriately screened for revascularization and/or cardiac resynchronization therapy if clinically indicated.
排除标准
- •Does not wish to participate
- •Mental incapacity to consent
- •CKD stage 5
- •Normal renal excretory function
- •Haemodynamically significant valvular disease amenable to surgery
- •Cardiac or renal transplantation
- •Considered by the investigator to unsuitable for PD due to previous abdominal surgeries, peritonitis, social circumstances or other reason
结局指标
主要结局
The primary end-point is a change of 25 metres walked
时间窗: Baseline to week 28
6 Minute Walk Test
次要结局
- Change in Derby Evaluation of Illness online visual analogue scale(Baseline to week 28)
- All cause hospitalisations(Baseline to week 28)
- All cause mortality(Baseline to week 28)
- Heart Failure related hospitalisations(Baseline to week 28)
- Change in KCCQ score(Baseline to week 28)
- Change in SF36 score(Baseline to week 28)
- Heart failure related mortality(Baseline to week 28)