PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Peritoneal Dialysis Group These participants will continue to receive standard HF care and Peritoneal Dialysis with a single daily exchange of icodextrin. |
Procedure: Peritoneal 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.
|
| No Intervention: Control Group These participants will continue to receive standard HF care. |
Outcome Measures
Primary Outcome Measures
- The primary end-point is a change of 25 metres walked [Baseline to week 28]
6 Minute Walk Test
Secondary Outcome Measures
- Change in KCCQ score [Baseline to week 28]
Kansas City Cardiomyopathy Questionnaire
- Change in SF36 score [Baseline to week 28]
Short Form 36 questionnaire
- Change in Derby Evaluation of Illness online visual analogue scale [Baseline to week 28]
Derby Evaluation of Illness online visual analogue scale
- Heart Failure related hospitalisations [Baseline to week 28]
Recording the number of hospitalisations relating to Heart Failure
- 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
Other Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Severe heart failure (NYHA grade III or IV)
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Chronic kidney disease stage 3-4
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Fluid overload resistant to diuretics OR hospital admission for HF in last 6 months
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Left ventricular ejection fraction ≤40% in last 2 years (moderate/severe)
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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
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Appropriately screened for revascularization and/or cardiac resynchronization therapy if clinically indicated.
Exclusion Criteria:
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Does not wish to participate
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Mental incapacity to consent
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CKD stage 5
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Normal renal excretory function
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Haemodynamically significant valvular disease amenable to surgery
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Cardiac or renal transplantation
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Considered by the investigator to unsuitable for PD due to previous abdominal surgeries, peritonitis, social circumstances or other reason
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Derby Teaching Hospitals NHS Foundation Trust | Derby | Derbyshire | United Kingdom | DE22 3DT |
Sponsors and Collaborators
- University of Nottingham
- British Heart Foundation
Investigators
- Principal Investigator: Maarten Taal, University of Nottingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRAS project ID: 158992
- ref: PG/13/27/29864