Chronic Kidney Disease, Heart Failure
Conditions
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.
Interventions
PROCEDUREPeritoneal Dialysis
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.
Sponsors
British Heart Foundation
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary end-point is a change of 25 metres walked | Baseline to week 28 | 6 Minute Walk Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Heart failure related mortality | Baseline to week 28 | Recording the number of heart failure deaths |
| All cause mortality | Baseline to week 28 | Recording the number of all cause deaths |
| 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 hospitalisations | Baseline to week 28 | Recording the number of hospitalisations relating to Heart Failure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Is the Derby Evaluation of Illness online visual analogue scale more sensitive than pen and ink questionnaires | Baseline to week 28 | Comparison between the scores from pen and ink questionnaires and the online visual analogue scale |
| Episodes of PD associated peritoneal infection | Baseline to week 28 | Recording the numbers of PD associated peritoneal infections |
| Adverse events spontaneously reported during the study | Baseline to week 28 | Recording and reporting adverse events |
Countries
United Kingdom
Outcome results
None listed