Validating a new cardiac MRI technique for dialysis patients
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
Run by University of Leicester · NCT03586518 · Data updated 2026-11-12
This study is testing a new type of heart scan to see if it can accurately show heart damage in people who are on dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 9 (estimated) |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Status | Recruiting |
| Started | November 3, 2019 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | April 18, 2025 |
| Trial ID | NCT03586518 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are prevalent hemodialysis patients who have been on dialysis for more than three months and are on the supportive care register.
✕Probably not a fit
Patients who may not benefit from this study include those with contraindications to MRI scans or those with expected infiltrative cardiomyopathy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to validate a novel, non-contrast cardiac MRI technique called native T1 mapping in patients undergoing hemodialysis. The research will compare the results of this imaging method with actual levels of myocardial fibrosis obtained post-mortem. By assessing the accuracy of native T1 mapping, the study seeks to establish it as a reliable biomarker for myocardial scarring in patients with end-stage kidney disease. The study involves cardiac MRI scans, echocardiograms, and blood sample analysis to gather comprehensive data on heart health in this population.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to accurately assess heart scarring in dialysis patients, leading to better management of their cardiac health.
How similar studies have gone: While the use of native T1 mapping has shown promise in other studies, this specific application in hemodialysis patients is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom Recruiting
Study contacts
- Principal investigator: James Burton, DM, FRCP — Associate Professor in Renal Medicine
- Study coordinator: James Burton, DM, FRCP
- Email: jb343@le.ac.uk
- Phone: +44 (0)116 2588043
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.