PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Heart Failure, Chronic Kidney Disease

Intervention / Treatment
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* Procedure: Peritoneal Dialysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peritoneal Dialysis Group<br>These participants will continue to receive standard HF care and Peritoneal Dialysis with a single daily exchange of icodextrin. | Procedure: Peritoneal Dialysis<br>* 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.<br>|
| No Intervention: Control Group<br>These participants will continue to receive standard HF care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end-point is a change of 25 metres walked | 6 Minute Walk Test | Baseline to week 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in KCCQ score | Kansas City Cardiomyopathy Questionnaire | Baseline to week 28 | 
| Change in SF36 score | Short Form 36 questionnaire | Baseline to week 28 | 
| Change in Derby Evaluation of Illness online visual analogue scale | Derby Evaluation of Illness online visual analogue scale | Baseline to week 28 | 
| Heart Failure related hospitalisations | Recording the number of hospitalisations relating to Heart Failure | Baseline to week 28 | 
| All cause hospitalisations | Recording the number of hospitalisations for all causes | Baseline to week 28 | 
| Heart failure related mortality | Recording the number of heart failure deaths | Baseline to week 28 | 
| All cause mortality | Recording the number of all cause deaths | Baseline to week 28 |