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

University of Nottingham

Status

Terminated

Conditions

Chronic Kidney Disease

Heart Failure

Treatments

Procedure: Peritoneal Dialysis

Study type

Interventional

Funder types

Other

Identifiers

NCT02708407

ref: PG/13/27/29864 (Other Grant/Funding Number)

IRAS project ID: 158992

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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