The Cardiac Uraemic fibrosis Detection in DiaLysis patiEnts study
| ISRCTN | ISRCTN99591655 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99591655 |
| Secondary identifying numbers | 2.0 |
- Submission date
- 28/05/2014
- Registration date
- 16/07/2014
- Last edited
- 16/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
BHF Cardiovascular Research Centre
University of Glasgow
126 University Place
Glasgow
G12 8TA
United Kingdom
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The Cardiac Uraemic fibrosis Detection in DiaLysis patiEnts study: an observational cohort study |
| Study acronym | CUDDLE |
| Study objectives | 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(s) | West of Scotland Research Ethics Committee 3; 21/01/2014; 13/WS/0301 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2015 |
| Completion date | 01/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 35 |
| Key inclusion criteria | Adult patients who have been treated with haemodialysis for <1 year are eligible |
| Key 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) |
| Date of first enrolment | 01/06/2015 |
| Date of final enrolment | 01/06/2017 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
G12 8TA
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Maureen Travers
Tennent Institute
Western Infirmary
Glasgow
G11 6NT
Scotland
United Kingdom
"ROR" |
https://ror.org/05kdz4d87 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/10/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/08/2018: Publication reference added
