Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Patients with kidney failure treated with dialysis are at very high risk of heart disease which carries with it a high risk of death and a drastic impact on a patients quality of life. This can be due to the fact that kidney disease can cause enlargement of the heart (cardiomegaly); this in turn can result in abnormal heart rhythms (arrhythmia) which can be life threatening. This study will look at a new method of MRI scanning to detect changes in heart function and scarring of the heart muscle that happens in the first year of dialysis treatment.

Who can participate?
Adult kidney disease patients who have been treated with haemodialysis for less than a year.

What does the study involve?
Each participant will be asked to undergo ECG tracing (which records heart rate and rhythm), a MRI scan of the heart and blood tests at their first visit and then six months later. This is done to see if there are any changes that may lead to kidney failure.

What are the possible benefits and risks of participating?
There is no direct benefit in participating though it is hoped that this study will allow us to develop better tests and treatment plans to reduce the risk of heart disease in patients with kidney failure. Some patients find having an MRI scan a little suffocating but there are no other risks anticipated with the study.

Where is the study run from?
The study is being run between the Glasgow Renal and Transplant Unit, NHS Greater Glasgow and Clyde (UK) and the University of Glasgow (UK).

When is the study starting and how long is it expected to run for?
The study will start in June 2015 and will run for two years.

Who is funding the study?
Kidney Research UK

Who is the main contact?
Dr Patrick Mark

Trial website

Contact information



Primary contact

Dr Patrick Mark


Contact details

BHF Cardiovascular Research Centre
University of Glasgow
126 University Place
G12 8TA
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The Cardiac Uraemic fibrosis Detection in DiaLysis patiEnts study: an observational cohort study



Study hypothesis

We hypothesise that cardiac fibrosis (scarring) can be seen on a MRI scan in patients treated with dialysis for kidney failure. We believe that this scarring progresses over the first year of dialysis treatment.

Ethics approval

West of Scotland Research Ethics Committee 3; 21/01/2014; 13/WS/0301

Study design

Observational cohort study

Primary study design


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet

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


Renal failure


Each subject will have a heart tracing (ECG) performed before and after a haemodialysis session with some blood tests taken for research at the time of haemodialysis. The next day, subjects will undergo MRI scanning of the heart to look for any evidence of scar tissue. An ECG will be repeated at the time of MRI scanning. The ECGs, MRI scan of heart and blood tests will be repeated after 6 months to see if there have been any changes, which might be related to kidney failure.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Volume of myocardial fibrosis on cardiac MRI scanning. This will be measured by MRI scanning of the heart at baseline and on a follow up MRI 6 months later.

Secondary outcome measures

1. Change in serum brain natriuretic peptide
2. Simple correlations will be tested between presence/volume of fibrosis and serum markers of cardiac muscle enlargements/fibrosis and features of arrhythmia on ECG (heart tracing)

Measured at baseline and 6 months later

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Adult patients who have been treated with haemodialysis for <1 year are eligible

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Live donor transplant planned during the next 6 months
2. Predicted life expectancy <6months
3. Inability to give informed consent
4. Contraindications to MRI imaging (pacemaker, extreme claustrophobia)
5. Atrial fibrillation (makes gating of CMR images difficult)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

BHF Cardiovascular Research Centre
G12 8TA
United Kingdom

Sponsor information


NHS Greater Glasgow and Clyde (UK)

Sponsor details

c/o Maureen Travers
Tennent Institute
Western Infirmary
G11 6NT
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Kidney Research UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations


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

Basic results (scientific)

Publication list

2017 results in:

Publication citations

Additional files

Editorial Notes

16/08/2018: Publication reference added