Heart FailurePD-HFNCT02708407
PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease
A study testing Peritoneal Dialysis in people with Heart Failure and Chronic Kidney Disease, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Chronic Kidney Disease
- What is being tested?
- Peritoneal Dialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Derby Teaching Hospitals NHS Foundation Trust
Derby, Derbyshire, DE22 3DT
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, Chronic Kidney Disease
- Being tested
- Peritoneal Dialysis
- Medical subject headings
- Heart Failure, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal DialysisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal Dialysis Group | Experimental | These participants will continue to receive standard HF care and Peritoneal Dialysis with a single daily exchange of icodextrin. Receives: Procedure: Peritoneal Dialysis |
| Control Group | No intervention | These participants will continue to receive standard HF care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point is a change of 25 metres walked
6 Minute Walk Test
Measured: Baseline to week 28
Secondary outcomes (7)
Change in KCCQ score
Kansas City Cardiomyopathy Questionnaire
Measured: Baseline to week 28
Change in SF36 score
Short Form 36 questionnaire
Measured: Baseline to week 28
Change in Derby Evaluation of Illness online visual analogue scale
Derby Evaluation of Illness online visual analogue scale
Measured: Baseline to week 28
Heart Failure related hospitalisations
Recording the number of hospitalisations relating to Heart Failure
Measured: Baseline to week 28
All cause hospitalisations
Recording the number of hospitalisations for all causes
Measured: Baseline to week 28
Heart failure related mortality
Recording the number of heart failure deaths
Measured: Baseline to week 28
All cause mortality
Recording the number of all cause deaths
Measured: Baseline to week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: Inability to recruit adequate number of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Maarten Taal, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708407
- Sponsor's protocol ID
- IRAS project ID: 158992
- Other IDs
- ref: PG/13/27/29864
- Acronym
- PD-HF
- Status last verified
- Jan 2020
- First submitted
- 18 Jan 2016
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02708407
- Acronym / sponsor ID
- PD-HF / IRAS project ID: 158992
- Conditions
- Heart Failure, Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit adequate number of participants
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Jan 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peritoneal Dialysis Group | Experimental | Procedure: Peritoneal DialysisThese 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Does not wish to participate
- Mental incapacity to consent
- CKD stage 5
- Normal renal excretory function
- Haemodynamically significant valvular disease amenable to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peritoneal DialysisOne 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. | Procedure or surgery | Peritoneal Dialysis Group |
Primary outcome
The primary end-point is a change of 25 metres walked
Time frame: Baseline to week 28
6 Minute Walk Test
7 secondary outcomes
Change in KCCQ score
Time frame: Baseline to week 28
Change in SF36 score
Time frame: Baseline to week 28
Change in Derby Evaluation of Illness online visual analogue scale
Time frame: Baseline to week 28
Heart Failure related hospitalisations
Time frame: Baseline to week 28
All cause hospitalisations
Time frame: Baseline to week 28
Heart failure related mortality
Time frame: Baseline to week 28
All cause mortality
Time frame: Baseline to week 28
Results and safety
The study was stopped early (reason given: Inability to recruit adequate number of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten Taal principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peritoneal Dialysis in people with Heart Failure and Chronic Kidney Disease, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inability to recruit adequate number of participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end-point is a change of 25 metres walked (time frame: Baseline to week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.