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

NCT ID: NCT02708407

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-06-30

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.

Conditions

Heart Failure; Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peritoneal Dialysis Group

These participants will continue to receive standard HF care and Peritoneal Dialysis with a single daily exchange of icodextrin.

Group Type: EXPERIMENTAL

Peritoneal Dialysis

Intervention Type: PROCEDURE

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.

Control Group

These participants will continue to receive standard HF care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British Heart Foundation

OTHER

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maarten Taal

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

Derby Teaching Hospitals NHS Foundation Trust

Derby, Derbyshire, United Kingdom

Countries

United Kingdom

Other Identifiers

ref: PG/13/27/29864

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRAS project ID: 158992

Identifier Type: -

Identifier Source: org_study_id