At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Cardiac MRI scan (diagnostic test), Echocardiogram (diagnostic test), Cardiac explantation (procedure), 48-Hour continuous cardiac monitoring (diagnostic test)
- How long the study runs
- Study runs about 73 months (dates as stated)
- About the drug or intervention
- Cardiac MRI scan — diagnostic test: A non-contrast cardiac MRI (CMR) scan at 3-Tesla platform (Skyra, Siemens Medical Imaging, Erlangen, Germany). · Echocardiogram — diagnostic test: Assessments will include: LV size and function as per the American Society of Echocardiography guidelines. · Cardiac explantation — procedure: A limited post-mortem will be performed to retrieve patients' hearts for preparation and storage at St George's University, London where direct comparison will be made between levels of scarring seen directly under the microscope between that on the MRI scans. · 48-Hour continuous cardiac monitoring — diagnostic test: Attach continuous Holter monitor (Schiller, medilog®AR12 plus/AR4 plus/FD5 plus, Baar, Switzerland) that will start before dialysis and terminate just before the subsequent dialysis treatment 48h later. · Blood samples — diagnostic test: Collect blood samples from the arterial needle before dialysis.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 9
- Started
- 2019-11-03
- Last checked
- 2025-04
Plain English Summary
What is this study?
- • Testing a new treatment for end stage kidney disease
- • Clinical study - 9 participants
- • There are currently no good ways of measuring levels of scarring in the hearts of patients with advanced kidney disease and patients on dialysis, although recent research has shown a new cardiac MRI technique, called native T1 mapping, may provide a solution to this
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with end stage kidney disease
Where?
- • Leicester - University Hospitals of Leicester NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
There are currently no good ways of measuring levels of scarring in the hearts of patients with advanced kidney disease and patients on dialysis, although recent research has shown a new cardiac MRI technique, called native T1 mapping, may provide a solution to this. To assess the accuracy of this novel technique in dialysis patients, it is essential to undertake a study which compares native T1 mapping to actual levels of scarring in the hearts of patients on dialysis.
More detail
Native T1 mapping is a novel, non-contrast, cardiac MRI technique that characterises myocardial tissue by exploiting the different water content of tissues. It correlates well with histo-pathological levels of myocardial fibrosis in diseases of pressure overload such as aortic stenosis. There is growing evidence to demonstrate the potential of native T1 mapping as an imaging biomarker of myocardial fibrosis in patients with ESRD; myocardial native T1 values are higher in patients with ESRD than controls, and associate with measures of myocardial strain and circulating markers of cardiac dysfunction. Although native T1 times are affected by water content of tissues, our group has shown that native T1 times are not influenced by clinical changes in fluid status in HD patients and that the inter-study reproducibility and intra- and inter-observer variability of native T1 are outstanding. Native T1 mapping is a promising, non-invasive imaging biomarker of myocardial fibrosis in patients with advanced renal disease. It is essential that the technique is validated against histology before further use in clinical studies. The aim of this study is to directly assess the relationship between native T1 mapping and levels of MF examined at post-mortem in haemodialysis patients.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Prevalent haemodialysis patient (more than 3 months)
- ✓Active on the supportive care register with anticipated death in the subsequent 12 months
- ✓Able to give agreement to take part
- ✓Consent to donation of heart for research following death
- ✓Able to understand written and verbal explanations in English
Who cannot take part
- ✗safety concern to MRI scan (e.g. pacemaker, incompatible metallic implants, claustrophobia)
- ✗Patients with expected or potential infiltrative cardiomyopathy (e.g. amyloidosis)
- ✗Unable to give agreement to take part
- ✗Unable to understand written and verbal explanations in English
See the full criteria
Where Is This Study? (1 UK site)
University Hospitals of Leicester NHS Trust
Leicester LE5 4PW, United Kingdom
How to Get in Touch
James Burton, DM, FRCP
Sponsor contactCONTACT
Matthew Graham-Brown, MBChB, MRCP
Sponsor contactCONTACT