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
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 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
01/06/2015
Overall trial end date
01/06/2017
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29070834