End Stage Kidney DiseaseCONFIRMNCT03586518
Validating Novel, Non-contrast Cardiac MRI Imaging in Haemodialysis Patients
An observational study of End Stage Kidney Disease and Fibrosis Myocardial, run by University of Leicester at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease, Fibrosis Myocardial
- What is being tested?
- Cardiac MRI scan, Echocardiogram and Cardiac explantation
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Nov 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The plans for patient recruitment were developed in partnership with our local haemodialysis patient participation and involvement group. Patients will be identified by means of a well established supportive care register for haemodialysis patients. These patients, and often their families, have engaged in discussion about end-of-life care, including discussions about limitations on care and preferred place of death.
Who may be able to join
- Prevalent haemodialysis patient (more than 3 months)
- Active on the supportive care register with anticipated death in the subsequent 12 months
- Able to give informed consent
- Consent to donation of heart for research following death
- Able to understand written and verbal explanations in English
Who cannot join
- Contraindication to MRI scan (e.g. pacemaker, incompatible metallic implants, claustrophobia)
- Patients with expected or potential infiltrative cardiomyopathy (e.g. amyloidosis)
- Unable to give informed consent
- Unable to understand written and verbal explanations in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE5 4PW
James Burton, FRCP, 01162588043, jb343@le.ac.uk
Matthew Graham-Brown, MRCP
About this study
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
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.
Read the detailed description
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.
- Conditions
- End Stage Kidney Disease, Fibrosis Myocardial
- Being tested
- Cardiac MRI scan, Echocardiogram, Cardiac explantation, 48-Hour continuous cardiac monitoring, Blood samples
- Keywords
- Cardiac MRI, Hemodialysis, Myocardial Fibrosis, Myocardial Inflammation
- Medical subject headings
- Kidney Failure, Chronic, Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRI scanDiagnostic test
Also called CMR
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.
EchocardiogramDiagnostic test
Also called ECHO
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.
Cardiac explantationProcedure or surgery
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 monitoringDiagnostic test
Also called Holter
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 samplesDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Haemodialysis patients | 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.
Inclusion:
* Prevalent haemodialysis patient (more than 3 months)
* Active on the supportive care register with anticipated death in the subsequent 12 months
* Able to give informed consent
* Consent to donation of heart for research following death
* Able to understand written and verbal explanations in English
Exclusion:
* Contraindication to MRI scan (e.g. pacemaker, incompatible metallic implants, claustrophobia)
* Patients with expected or potential infiltrative cardiomyopathy (e.g. amyloidosis)
* Unable to give informed consent
* Unable to understand written and verbal explanations in English Receives: Diagnostic Test: Cardiac MRI scan; Diagnostic Test: Echocardiogram; Procedure: Cardiac explantation; Diagnostic Test: 48-Hour continuous cardiac monitoring; Diagnostic Test: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between MRI and histological measures of cardiac fibrosis
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.
Measured: Cardiac MRI performed within 12-months of histological samples obtained post-mortem
Secondary outcomes (4)
Accuracy of MRI versus ECHO in the measurement of cardiac fibrosis
Relationship between integrated backscatter (measured with echocardiography) and levels of myocardial fibrosis on histology measured at post-mortem.
Measured: Echocardiograms performed within 12-months of histological samples obtained post-mortem
Relationship between cardiac fibrosis and heart rhythm
Relationship between continuous Holter-monitor data and levels of myocardial fibrosis on histology measured at post-mortem.
Measured: Continuous Holter recording performed within 12-months of histological samples obtained post-mortem
Correlation between cardiac fibrosis and relevant circulating biomarkers
Relationship between humoral markers of cardiac dysfunction of fibrosis and levels of myocardial fibrosis on histology measured at post-mortem
Measured: Samples collected within 12-months of histological samples obtained post-mortem
Additional cardiac MRI techniques and the measurement of cardiac fibrosis
The relationship between additional, non-contrast CMR techniques and histology at post-mortem
Measured: Cardiac MRI performed within 12-months of histological samples obtained post-mortem
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start3 Nov 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester, St George's, University of London
- Responsible party
- Sponsor
- Investigators
- James Burton, DM, FRCP, Principal investigator, Associate Professor in Renal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586518
- Sponsor's protocol ID
- 0674
- Acronym
- CONFIRM
- Status last verified
- Apr 2025
- First submitted
- 2 Jul 2018
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full study protocol will be published online, open access.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03586518
- Acronym / sponsor ID
- CONFIRM / 0674
- Conditions
- End Stage Kidney Disease, Fibrosis Myocardial
- Keywords
- Cardiac MRI, Hemodialysis, Myocardial Fibrosis, Myocardial Inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester, St George's, University of London
- Study start
- 3 Nov 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Haemodialysis patients | – | Diagnostic Test: Cardiac MRI scan, Diagnostic Test: Echocardiogram, Procedure: Cardiac explantation, Diagnostic Test: 48-Hour continuous cardiac monitoring, Diagnostic Test: Blood samplesThe 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. Inclusion: * Prevalent haemodialysis patient (more than 3 months) * Active on the supportive care register with anticipated death in the subsequent 12 months * Able to give informed consent * Consent to donation of heart for research following death * Able to understand written and verbal explanations in English Exclusion: * Contraindication to MRI scan (e.g. pacemaker, incompatible metallic implants, claustrophobia) * Patients with expected or potential infiltrative cardiomyopathy (e.g. amyloidosis) * Unable to give informed consent * Unable to understand written and verbal explanations in English |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The plans for patient recruitment were developed in partnership with our local haemodialysis patient participation and involvement group. Patients will be identified by means of a well established supportive care register for haemodialysis patients. These patients, and often their families, have engaged in discussion about end-of-life care, including discussions about limitations on care and preferred place of death.
Key inclusion criteria (5 listed)
- Prevalent haemodialysis patient (more than 3 months)
- Active on the supportive care register with anticipated death in the subsequent 12 months
- Able to give informed consent
- Consent to donation of heart for research following death
- Able to understand written and verbal explanations in English
Key exclusion criteria (4 listed)
- Contraindication to MRI scan (e.g. pacemaker, incompatible metallic implants, claustrophobia)
- Patients with expected or potential infiltrative cardiomyopathy (e.g. amyloidosis)
- Unable to give informed consent
- Unable to understand written and verbal explanations in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRI scanAlso: CMRA 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. | Diagnostic test | Haemodialysis patients |
| EchocardiogramAlso: ECHOAssessments 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. | Diagnostic test | Haemodialysis patients |
| Cardiac explantationA 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. | Procedure or surgery | Haemodialysis patients |
| 48-Hour continuous cardiac monitoringAlso: HolterAttach 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. | Diagnostic test | Haemodialysis patients |
| Blood samplesCollect 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. | Diagnostic test | Haemodialysis patients |
Primary outcome
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.
4 secondary outcomes
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 cardiac fibrosis and heart rhythm
Time frame: Continuous Holter recording performed within 12-months of histological samples obtained post-mortem
Correlation between cardiac fibrosis and relevant circulating biomarkers
Time frame: Samples collected within 12-months of histological samples obtained 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: Yes. The full study protocol will be published online, open access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Burton, DM, FRCP principal investigator
Associate Professor in Renal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Kidney Disease and Fibrosis Myocardial, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Burton, DM, FRCP (+44 (0)116 2588043, jb343@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between MRI and histological measures of cardiac fibrosis (time frame: Cardiac MRI performed within 12-months of histological samples obtained post-mortem). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.