Condition category
Circulatory System
Date applied
08/01/2015
Date assigned
09/01/2015
Last edited
16/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Heart failure is a condition caused by the heart failing to pump enough blood around the body at the right pressure. Once patients with severe heart failure are taking the maximum tolerated dose of heart failure medication there are no other treatments available for those who still have symptoms of shortness of breath, limited mobility and poor quality of life. In studies many patients say that they would prefer treatments that improve their quality of life even at the expense of reduced length. Peritoneal dialysis involves pumping dialysis fluid into the space inside the abdomen (tummy) to draw out waste products from the blood. The aim of this study is to find out if peritoneal dialysis can be an effective treatment for patients with heart failure causing severe symptoms and reduced kidney function.

Who can participate?
Patients with severe heart failure and chronic kidney disease, who are taking an optimal dose of heart failure medication and considered suitable for peritoneal dialysis

What does the study involve?
Participants are randomly allocated to receive either best standard heart failure care (control group) or best standard heart failure care with peritoneal dialysis (intervention group). Participants have five study visits over a 32-week period. Depending on the visit, participants complete a range of quality of life and symptom questionnaires, a 6-minute walk distance test, blood test, 24-hour urine test, estimation of body composition and weight measurement, as well as questions about medical history and drug dosage.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Royal Derby Hospital (UK)

When is the study starting and how long is it expected to run for?
March 2015 to September 2016

Who is funding the study?
British Heart Foundation (UK)

Who is the main contact?
Fiona Robertson

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Fiona Robertson

ORCID ID

Contact details

Department of Renal Medicine
University Of Nottingham
Division of Medical Sciences and Graduate Entry Medicine
Royal Derby Hospital Centre
Uttoxeter Road
Derby
DE22 3DT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14080

Study information

Scientific title

PD-HF: a multicentre randomised controlled trial of Peritoneal Dialysis using icodextrin-based solutions for patients with advanced Heart Failure and stage 3-4 chronic kidney disease

Acronym

PD-HF

Study hypothesis

Once patients with severe heart failure (HF) are taking the maximum tolerated dose of heart failure medication there are no other treatments available for those who still have symptoms of shortness of breath, limited mobility and poor quality of life. In studies many patients say that they would prefer treatments that improve quality of life even at the expense of reduced length. The purpose of this study is to find out if peritoneal dialysis can be an effective treatment for patients with heart failure causing severe symptoms and reduced kidney function.

Ethics approval

14/EM/1174

Study design

Randomised; Interventional

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular

Intervention

Participants will be randomised into receiving best standard heart failure care (control group) or best standard heart failure care with peritoneal dialysis (intervention group).

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Assess the efficacy of ultrafiltration by PD
2. To assess the efficacy of ultrafiltration by PD in patients with severe HF and moderate CKD on symptoms of HF

Secondary outcome measures

N/A

Overall trial start date

30/03/2015

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged>18, no upper age limit
2. Severe HF (New York Heart Association grade III or IV)
3. Chronic Kidney Disease stage 34, (MDRD estimated GFR of 1660ml/min on 2 occasions >3 months apart)
4. Fluid overload resistant to diuretics* OR hospital admission for heart failure in last 6 months
5. Left ventricular ejection fraction = 40% in the last 2 years
6. Using optimal HF medication for = 8 weeks including ACE-inhibitor
OR angiotensin receptor blocker AND aldosterone antagonist AND beta-blocker unless intolerant and without dose change for = 4 Weeks.
7. Appropriately screened for revascularization and/or cardiac resynchronization therapy if clinically indicated.

*Diuretic resistance is defined as clinical signs of fluid overload despite >120mg of furosemide/3mg bumetanide/day.
‘Fluid overload’ is clinically defined as at least 2 of the following:
1. Peripheral or sacral oedema
2. Jugular venous distension = 7cm
3. Radiographic pulmonary oedema or pleural effusion
4. Enlarged liver or ascites
5. Pulmonary rales, paroxysmal nocturnal dyspnoea, or orthopnoea

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 130; UK Sample Size: 130

Participant exclusion criteria

1. Does not wish to participate
2. Mental incapacity to consent
3. CKD stage 5 (estimated GFR of < 15ml/min)
4. Normal renal excretory function (estimated GFR of >60ml.min)
5. Haemodynamically significant valvular disease amenable to surgery
6. Cardiac or renal transplantation
7. Considered by the investigator to be unsuitable for PD due to previous abdominal surgeries, peritonitis, social circumstances or other reason

Recruitment start date

30/03/2015

Recruitment end date

30/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

c/o Ms. Angela Shone
Head of Research Governance
Research & Graduate Services
King’s Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/06/2016: Plain English summary added.