Condition category
Urological and Genital Diseases
Date applied
28/05/2014
Date assigned
16/07/2014
Last edited
16/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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
patrick.mark@glasgow.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Patrick Mark

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2.0

Study information

Scientific title

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

Acronym

CUDDLE

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

Observational

Secondary study design

Cohort study

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

Renal failure

Intervention

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/06/2015

Overall trial end date

01/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

35

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

01/06/2015

Recruitment end date

01/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

BHF Cardiovascular Research Centre
Glasgow
G12 8TA
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Kidney Research UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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