PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease (PD-HF)
2020年1月20日 更新者：University of Nottingham
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
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
11
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Derbyshire
-
Derby、Derbyshire、英国、DE22 3DT
- Derby Teaching Hospitals NHS Foundation Trust
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Peritoneal Dialysis Group
These participants will continue to receive standard HF care and Peritoneal Dialysis with a single daily exchange of icodextrin.
|
One week after insertion of a PD catheter the intervention group will received a single nightly exchange, using dialysis fluid containing icodextrin; a variable proportion of participants may require a second exchange as directed by the consultant nephrologist as part of routine care.
The second exchange would use dialysis fluid containing glucose, not icodextrin.
Support and training will be given to each participant by the PD specialist team.
|
|
无干预：Control Group
These participants will continue to receive standard HF care.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The primary end-point is a change of 25 metres walked
大体时间：Baseline to week 28
|
6 Minute Walk Test
|
Baseline to week 28
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in KCCQ score
大体时间：Baseline to week 28
|
Kansas City Cardiomyopathy Questionnaire
|
Baseline to week 28
|
|
Change in SF36 score
大体时间：Baseline to week 28
|
Short Form 36 questionnaire
|
Baseline to week 28
|
|
Change in Derby Evaluation of Illness online visual analogue scale
大体时间：Baseline to week 28
|
Derby Evaluation of Illness online visual analogue scale
|
Baseline to week 28
|
|
Heart Failure related hospitalisations
大体时间：Baseline to week 28
|
Recording the number of hospitalisations relating to Heart Failure
|
Baseline to week 28
|
|
All cause hospitalisations
大体时间：Baseline to week 28
|
Recording the number of hospitalisations for all causes
|
Baseline to week 28
|
|
Heart failure related mortality
大体时间：Baseline to week 28
|
Recording the number of heart failure deaths
|
Baseline to week 28
|
|
All cause mortality
大体时间：Baseline to week 28
|
Recording the number of all cause deaths
|
Baseline to week 28
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Episodes of PD associated peritoneal infection
大体时间：Baseline to week 28
|
Recording the numbers of PD associated peritoneal infections
|
Baseline to week 28
|
|
Adverse events spontaneously reported during the study
大体时间：Baseline to week 28
|
Recording and reporting adverse events
|
Baseline to week 28
|
|
Is the Derby Evaluation of Illness online visual analogue scale more sensitive than pen and ink questionnaires
大体时间：Baseline to week 28
|
Comparison between the scores from pen and ink questionnaires and the online visual analogue scale
|
Baseline to week 28
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Maarten Taal、University of Nottingham
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年1月1日
初级完成 (实际的)
2017年6月1日
研究完成 (实际的)
2017年6月1日
研究注册日期
首次提交
2016年1月18日
首先提交符合 QC 标准的
2016年3月9日
首次发布 (估计)
2016年3月15日
研究记录更新
最后更新发布 (实际的)
2020年1月23日
上次提交的符合 QC 标准的更新
2020年1月20日
最后验证
2020年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.