PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02708407
• Other study ID #: IRAS project ID: 158992
• Secondary ID: ref: PG/13/27/29
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: January 2020
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Heart Failure
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Procedure:
• Peritoneal Dialysis
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.

Locations

Country	Name	City	State
United Kingdom	Derby Teaching Hospitals NHS Foundation Trust	Derby	Derbyshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Episodes of PD associated peritoneal infection	Recording the numbers of PD associated peritoneal infections	Baseline to week 28
Other	Adverse events spontaneously reported during the study	Recording and reporting adverse events	Baseline to week 28
Other	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
Primary	The primary end-point is a change of 25 metres walked	6 Minute Walk Test	Baseline to week 28
Secondary	Change in KCCQ score	Kansas City Cardiomyopathy Questionnaire	Baseline to week 28
Secondary	Change in SF36 score	Short Form 36 questionnaire	Baseline to week 28
Secondary	Change in Derby Evaluation of Illness online visual analogue scale	Derby Evaluation of Illness online visual analogue scale	Baseline to week 28
Secondary	Heart Failure related hospitalisations	Recording the number of hospitalisations relating to Heart Failure	Baseline to week 28
Secondary	All cause hospitalisations	Recording the number of hospitalisations for all causes	Baseline to week 28
Secondary	Heart failure related mortality	Recording the number of heart failure deaths	Baseline to week 28
Secondary	All cause mortality	Recording the number of all cause deaths	Baseline to week 28