Back to resultsPD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease (PD-HF)
Primary Purpose
Heart Failure, Chronic Kidney Disease
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Peritoneal Dialysis
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- Derby Teaching Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Peritoneal Dialysis Group
Control Group
Arm Description
These participants will continue to receive standard HF care and Peritoneal Dialysis with a single daily exchange of icodextrin.
These participants will continue to receive standard HF care.
Outcomes
Primary Outcome Measures
The primary end-point is a change of 25 metres walked
6 Minute Walk Test
Secondary Outcome Measures
Change in KCCQ score
Kansas City Cardiomyopathy Questionnaire
Change in SF36 score
Short Form 36 questionnaire
Change in Derby Evaluation of Illness online visual analogue scale
Derby Evaluation of Illness online visual analogue scale
Heart Failure related hospitalisations
Recording the number of hospitalisations relating to Heart Failure
All cause hospitalisations
Recording the number of hospitalisations for all causes
Heart failure related mortality
Recording the number of heart failure deaths
All cause mortality
Recording the number of all cause deaths
Full Information
NCT ID
NCT02708407
First Posted
January 18, 2016
Last Updated
January 20, 2020
Sponsor
University of Nottingham
Collaborators
British Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02708407
Brief Title
PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease
Acronym
PD-HF
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit adequate number of participants
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
British Heart Foundation
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peritoneal Dialysis Group
Arm Type
Experimental
Arm Description
These participants will continue to receive standard HF care and Peritoneal Dialysis with a single daily exchange of icodextrin.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
These participants will continue to receive standard HF care.
Intervention Type
Procedure
Intervention Name(s)
Peritoneal Dialysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary end-point is a change of 25 metres walked
Description
6 Minute Walk Test
Time Frame
Baseline to week 28
Secondary Outcome Measure Information:
Title
Change in KCCQ score
Description
Kansas City Cardiomyopathy Questionnaire
Time Frame
Baseline to week 28
Title
Change in SF36 score
Description
Short Form 36 questionnaire
Time Frame
Baseline to week 28
Title
Change in Derby Evaluation of Illness online visual analogue scale
Description
Derby Evaluation of Illness online visual analogue scale
Time Frame
Baseline to week 28
Title
Heart Failure related hospitalisations
Description
Recording the number of hospitalisations relating to Heart Failure
Time Frame
Baseline to week 28
Title
All cause hospitalisations
Description
Recording the number of hospitalisations for all causes
Time Frame
Baseline to week 28
Title
Heart failure related mortality
Description
Recording the number of heart failure deaths
Time Frame
Baseline to week 28
Title
All cause mortality
Description
Recording the number of all cause deaths
Time Frame
Baseline to week 28
Other Pre-specified Outcome Measures:
Title
Episodes of PD associated peritoneal infection
Description
Recording the numbers of PD associated peritoneal infections
Time Frame
Baseline to week 28
Title
Adverse events spontaneously reported during the study
Description
Recording and reporting adverse events
Time Frame
Baseline to week 28
Title
Is the Derby Evaluation of Illness online visual analogue scale more sensitive than pen and ink questionnaires
Description
Comparison between the scores from pen and ink questionnaires and the online visual analogue scale
Time Frame
Baseline to week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarten Taal
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Derby Teaching Hospitals NHS Foundation Trust
City
Derby
State/Province
Derbyshire
ZIP/Postal Code
DE22 3DT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease
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