Clinical trial NCT02708407: PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Chronic Kidney Disease
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2016-03-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary end-point is a change of 25 metres walked
timeFrame: Baseline to week 28
Secondary outcomes:
measure: Change in KCCQ score
timeFrame: Baseline to week 28
measure: Change in SF36 score
timeFrame: Baseline to week 28
measure: Change in Derby Evaluation of Illness online visual analogue scale
timeFrame: Baseline to week 28
measure: Heart Failure related hospitalisations
timeFrame: Baseline to week 28
measure: All cause hospitalisations
timeFrame: Baseline to week 28
measure: Heart failure related mortality
timeFrame: Baseline to week 28
measure: All cause mortality
timeFrame: Baseline to week 28
Other outcomes:
measure: Episodes of PD associated peritoneal infection
timeFrame: Baseline to week 28
measure: Adverse events spontaneously reported during the study
timeFrame: Baseline to week 28
measure: Is the Derby Evaluation of Illness online visual analogue scale more sensitive than pen and ink questionnaires
timeFrame: Baseline to week 28
Locations:
city: Derby
country: United Kingdom
facility: Derby Teaching Hospitals NHS Foundation Trust
state: Derbyshire
Study officials:
affiliation: University of Nottingham
name: Maarten Taal
role: PRINCIPAL_INVESTIGATOR
References: