Validating Novel, Non-contrast Cardiac MRI Imaging in Haemodialysis Patients (CONFIRM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03586518|
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment|
|End Stage Kidney Disease Fibrosis Myocardial||Diagnostic Test: Cardiac MRI scan Diagnostic Test: Echocardiogram Procedure: Cardiac explantation Diagnostic Test: 48-Hour continuous cardiac monitoring Diagnostic Test: Blood samples|
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.
|Study Type :||Observational|
|Estimated Enrollment :||9 participants|
|Official Title:||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|
|Actual Study Start Date :||November 3, 2019|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
The plans for patient recruitment were developed in partnership with our local haemodialysis patient participation and involvement group. Patients will be identified from the supportive care register established for haemodialysis patients in Leicester in 2008.
Diagnostic Test: Cardiac MRI scan
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 Name: CMR
Diagnostic Test: Echocardiogram
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 Name: ECHO
Procedure: Cardiac explantation
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.
Diagnostic Test: 48-Hour continuous cardiac monitoring
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 Name: Holter
Diagnostic Test: Blood samples
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.
- Correlation between MRI and histological measures of cardiac fibrosis [ 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.
- Accuracy of MRI versus ECHO in the measurement of cardiac fibrosis [ 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.
- Relationship between cardiac fibrosis and heart rhythm [ 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.
- Correlation between cardiac fibrosis and relevant circulating biomarkers [ 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
- Additional cardiac MRI techniques and the measurement of cardiac fibrosis [ 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
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586518
|Contact: James Burton, DM, FRCP||+44 (0)116 firstname.lastname@example.org|
|Contact: Matthew Graham-Brown, MBChB, MRCP||+44 (0)116 email@example.com|
|University Hospitals of Leicester NHS Trust||Recruiting|
|Leicester, Leicestershire, United Kingdom, LE5 4PW|
|Contact: James Burton, FRCP 01162588043 firstname.lastname@example.org|
|Sub-Investigator: Matthew Graham-Brown, MRCP|
|Principal Investigator:||James Burton, DM, FRCP||Associate Professor in Renal Medicine|