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

NCT02708407 | Terminated DMC

• 2 other identifiers: IRAS project ID: 158992ref: PG/13/27/29864
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• The primary end-point is a change of 25 metres walked

  6 Minute Walk Test

  Baseline to week 28

Secondary Outcomes (7)

• Change in KCCQ score

  Baseline to week 28

• Change in SF36 score

  Baseline to week 28

• Change in Derby Evaluation of Illness online visual analogue scale

  Baseline to week 28

• Heart Failure related hospitalisations

  Baseline to week 28

• All cause hospitalisations

  Baseline to week 28

Other Outcomes (3)

• Episodes of PD associated peritoneal infection

  Baseline to week 28

• Adverse events spontaneously reported during the study

  Baseline to week 28

• Is the Derby Evaluation of Illness online visual analogue scale more sensitive than pen and ink questionnaires

  Baseline to week 28

Study Arms (2)

Peritoneal Dialysis Group

EXPERIMENTAL

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

Procedure: Peritoneal Dialysis

Control Group

NO INTERVENTION

These participants will continue to receive standard HF care.

Interventions

Peritoneal Dialysis 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.

Peritoneal Dialysis Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• British Heart Foundation: collaborator

Study Sites (1)

Derby Teaching Hospitals NHS Foundation Trust

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency, Chronic

Interventions

Peritoneal Dialysis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Dialysis; Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Maarten Taal

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: March 15, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

GB (1)