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

Not Applicable

Terminated

• Conditions: Heart Failure; Chronic Kidney Disease
• Interventions: Procedure: Peritoneal Dialysis

• Registration Number: NCT02708407
• Lead Sponsor: University of Nottingham

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-20
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peritoneal Dialysis Group	Peritoneal Dialysis	These participants will continue to receive standard HF care and Peritoneal Dialysis with a single daily exchange of icodextrin.

Primary Outcome Measures

Name	Time	Method
The primary end-point is a change of 25 metres walked	Baseline to week 28	6 Minute Walk Test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Derby Teaching Hospitals NHS Foundation Trust; 🇬🇧 Derby, Derbyshire, United Kingdom