University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE5 4PW, United Kingdom
Location status: Recruiting
Location contact
James Burton, FRCP
CONTACT
Matthew Graham-Brown, MRCP
SUB_INVESTIGATOR
NCT Number: NCT03586518
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Leicester, Leicestershire, LE5 4PW, United Kingdom
Location status: Recruiting
James Burton, FRCP
CONTACT
Matthew Graham-Brown, MRCP
SUB_INVESTIGATOR
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A non-contrast cardiac MRI (CMR) scan at 3-Tesla platform (Skyra, Siemens Medical Imaging, Erlangen, Germany).
This non-contrast CMR scan will principally determine: Left ventricular (LV) mass and volumes/ejection fraction and; fibrosis using T1 mapping.
Other names: CMR
Assessments will include: LV size and function as per the American Society of Echocardiography guidelines. In addition specific focus will be paid end-diastolic integrated backscatter measurements.
Other names: ECHO
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.
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.
Other names: Holter
Collect blood samples from the arterial needle before dialysis. Approximately 30 millilitres of blood will be collected and then be pipetted into cryotubes and frozen at -80°C in an electronically monitored freezer for analysis in batches throughout the study. These samples will be used to investigate the relationship between circulating biomarkers of fibrosis, the MRI scans and the histological samples.
Time frame: Cardiac MRI performed within 12-months of histological samples obtained post-mortem
To assess the correlation between native T1 values measured using cardiac MRI in haemodialysis patients approaching the end of their lives, with histological samples analysed post-mortem.
Time frame: Echocardiograms performed within 12-months of histological samples obtained post-mortem
Relationship between integrated backscatter (measured with echocardiography) and levels of myocardial fibrosis on histology measured at post-mortem.
Time frame: Continuous Holter recording performed within 12-months of histological samples obtained post-mortem
Relationship between continuous Holter-monitor data and levels of myocardial fibrosis on histology measured at post-mortem.
Time frame: Samples collected within 12-months of histological samples obtained post-mortem
Relationship between humoral markers of cardiac dysfunction of fibrosis and levels of myocardial fibrosis on histology measured at post-mortem
Time frame: Cardiac MRI performed within 12-months of histological samples obtained post-mortem
The relationship between additional, non-contrast CMR techniques and histology at post-mortem
Contact information is provided by the study sponsor or research team.
James Burton, DM, FRCP
CONTACT
Matthew Graham-Brown, MBChB, MRCP
CONTACT
University of Leicester
Other
Validating the Accuracy of Novel, Non-contrast, Cardiac Magnetic resOnaNce Imaging in Defining Myocardial FIbRosis in Patients With End-stage Renal Disease on haeModialysis: the CONFIRM Study
Acronym: CONFIRM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06356168
Chronic Disease, Disease Attributes
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT06613568
Chronic Disease, Disease Attributes
San Dimas, California, United States
View Trial DetailsNCT05715814
Chronic Disease, Disease Attributes
Toronto, Ontario, Canada
View Trial DetailsNCT07426380
Chronic Disease, Disease Attributes
Miami Lakes, Florida, United States
View Trial Details