Plain English Summary
Background and study aims
Heart failure is a condition caused by the heart failing to pump enough blood around the body at the right pressure. Once patients with severe heart failure 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 their quality of life even at the expense of reduced length. Peritoneal dialysis involves pumping dialysis fluid into the space inside the abdomen (tummy) to draw out waste products from the blood. The aim 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.
Who can participate?
Patients with severe heart failure and chronic kidney disease, who are taking an optimal dose of heart failure medication and considered suitable for peritoneal dialysis
What does the study involve?
Participants are randomly allocated to receive either best standard heart failure care (control group) or best standard heart failure care with peritoneal dialysis (intervention group). Participants have five study visits over a 32-week period. Depending on the visit, participants complete 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.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Royal Derby Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2015 to September 2016
Who is funding the study?
British Heart Foundation (UK)
Who is the main contact?
Fiona Robertson
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14080
Study information
Scientific title
PD-HF: a multicentre randomised controlled trial of Peritoneal Dialysis using icodextrin-based solutions for patients with advanced Heart Failure and stage 3-4 chronic kidney disease
Acronym
PD-HF
Study hypothesis
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.
Ethics approval
14/EM/1174
Study design
Randomised; Interventional
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Intervention
Participants will be randomised into receiving best standard heart failure care (control group) or best standard heart failure care with peritoneal dialysis (intervention group).
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Assess the efficacy of ultrafiltration by PD
2. To assess the efficacy of ultrafiltration by PD in patients with severe HF and moderate CKD on symptoms of HF
Secondary outcome measures
N/A
Overall trial start date
30/03/2015
Overall trial end date
30/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged>18, no upper age limit
2. Severe HF (New York Heart Association grade III or IV)
3. Chronic Kidney Disease stage 34, (MDRD estimated GFR of 1660ml/min on 2 occasions >3 months apart)
4. Fluid overload resistant to diuretics* OR hospital admission for heart failure in last 6 months
5. Left ventricular ejection fraction = 40% in the last 2 years
6. Using optimal HF medication for = 8 weeks including ACE-inhibitor
OR angiotensin receptor blocker AND aldosterone antagonist AND beta-blocker unless intolerant and without dose change for = 4 Weeks.
7. Appropriately screened for revascularization and/or cardiac resynchronization therapy if clinically indicated.
*Diuretic resistance is defined as clinical signs of fluid overload despite >120mg of furosemide/3mg bumetanide/day.
‘Fluid overload’ is clinically defined as at least 2 of the following:
1. Peripheral or sacral oedema
2. Jugular venous distension = 7cm
3. Radiographic pulmonary oedema or pleural effusion
4. Enlarged liver or ascites
5. Pulmonary rales, paroxysmal nocturnal dyspnoea, or orthopnoea
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 130; UK Sample Size: 130
Participant exclusion criteria
1. Does not wish to participate
2. Mental incapacity to consent
3. CKD stage 5 (estimated GFR of < 15ml/min)
4. Normal renal excretory function (estimated GFR of >60ml.min)
5. Haemodynamically significant valvular disease amenable to surgery
6. Cardiac or renal transplantation
7. Considered by the investigator to be unsuitable for PD due to previous abdominal surgeries, peritonitis, social circumstances or other reason
Recruitment start date
30/03/2015
Recruitment end date
30/09/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Funders
Funder type
Charity
Funder name
British Heart Foundation
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list