Validating a new cardiac MRI technique for dialysis patients
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
University of Leicester · NCT03586518
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 |
|---|---|
| Enrollment | 9 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leicester (other) |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT03586518 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who may not benefit from this study include those with contraindications to MRI scans or those with expected infiltrative cardiomyopathy.
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 performed: 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.
Eligibility criteria
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 this trial is running
Leicester, Leicestershire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: End Stage Kidney Disease, Fibrosis Myocardial, Cardiac MRI, Hemodialysis, Myocardial Fibrosis, Myocardial Inflammation