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| ID | Type | Description | Link |
|---|---|---|---|
| ref: PG/13/27/29864 | Other Grant/Funding Number | BHF grant |
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Inability to recruit adequate number of participants
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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peritoneal Dialysis Group | Experimental | These participants will continue to receive standard HF care and Peritoneal Dialysis with a single daily exchange of icodextrin. |
|
| Control Group | No Intervention | These participants will continue to receive standard HF care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peritoneal Dialysis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary end-point is a change of 25 metres walked | 6 Minute Walk Test | Baseline to week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in KCCQ score | Kansas City Cardiomyopathy Questionnaire | Baseline to week 28 |
| Change in SF36 score | Short Form 36 questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Episodes of PD associated peritoneal infection | Recording the numbers of PD associated peritoneal infections | Baseline to week 28 |
| Adverse events spontaneously reported during the study | Recording and reporting adverse events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maarten Taal | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Derby Teaching Hospitals NHS Foundation Trust | Derby | Derbyshire | DE22 3DT | United Kingdom |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D010530 | Peritoneal Dialysis |
| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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|
| 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 |
| Baseline to week 28 |
| Is the Derby Evaluation of Illness online visual analogue scale more sensitive than pen and ink questionnaires | Comparison between the scores from pen and ink questionnaires and the online visual analogue scale | Baseline to week 28 |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |