PD-HF
Research type
Research Study
Full title
PD-HF: A multi-centre randomised controlled trial of peritoneal dialysis using icodextrin-based solutions for patients with advanced heart failure and stage 3-4 chronic kidney disease.
IRAS ID
158992
Contact name
Maarten Taal
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
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.
Once patients with severe heart failure (HF) are taking the maximum tolerated dose of heart failure medication there are no other treatments available for those who still have symptoms of shortness of breath, limited mobility and poor quality of life. In studies many patients say that they would prefer treatments that improve quality of life even at the expense of reduced length.
The purpose of this study is to find out if peritoneal dialysis can be an effective treatment for patients with heart failure causing severe symptoms and reduced kidney function.
We aim to recruit 130 participants from 6 NHS sites over an 18 month recruitment period. Participants will be randomised into receiving best standard heart failure care (control group) or best standard heart failure care with peritoneal dialysis (intervention group). Potential participants will have severe HF, taking an optimal dose of HF medication, and chronic kidney disease (CKD) and be considered suitable for peritoneal dialysis (PD).
Once randomised to either the control group or the intervention group, participants will have 5 study visits over a 32 week period. Week 4 – 28 is the active treatment period and at the end of week 28 we hope to show a change of 25 metres in walking distance, a change in quality of life and symptom scores and reduced hospitalisation for HF. Depending on the visit, participants will have a range of quality of life and symptom questionnaires, a 6 minute walk distance test, blood test, 24 hour urine test, estimation of body composition and weight measurement as well as questions about medical history and drug dosage.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
14/EM/1174
Date of REC Opinion
19 Nov 2014
REC opinion
Further Information Favourable Opinion