The CONFIRM Study
Research type
Research Study
Full 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.
IRAS ID
242677
Contact name
James Burton
Contact email
Sponsor organisation
University of Leicester
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Patients on dialysis have abnormally high rates of heart problems which are related to the development of scarring in the heart muscle. Being able to accurately measure this scarring is important in terms of understanding how the disease progresses, being able to measure the response to new treatments and, for example, assessing suitability for transplantation. This study will assess how well a new cardiac MRI technique measures fibrosis in the hearts of dialysis patients by comparing scans directly to heart tissue obtained from patients who have donated their hearts for research following their death.
There are currently no good ways of measuring levels of scarring in the hearts of patients with advanced kidney disease and patients on dialysis, but recent work we have completed in Leicester has shown a new cardiac MRI technique may be able to determine levels of scarring in the hearts of patients on dialysis (native T1 mapping). To assess the accuracy of this 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.
With the help of extensive work with our dialysis patient and public involvement group this study plans to approach dialysis patients nearing the end of their lives, identified through the local, Leicester dialysis supportive care register, to discuss the possibility of them undertaking a cardiac MRI scan for measurement of levels of scarring in their hearts using native T1 mapping and then consenting to donate their heart after death to allow direct comparison between the scans we conduct and the levels of scarring in their heart that we find.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0322
Date of REC Opinion
11 Dec 2018
REC opinion
Further Information Favourable Opinion