Validating Novel, Non-contrast Cardiac MRI Imaging in Haemodialysis Patients — CONFIRM  

End Stage Kidney Disease Clinical Trial

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

Status Recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Fibrosis
• Fibrosis Myocardial
• Kidney Diseases
• Kidney Failure, Chronic

• NCT number: NCT03586518
• Study type: Observational
• Source: University of Leicester
• Contact: James Burton, DM, FRCP
• Phone: +44 (0)116 2588043
• Email: jb343@le.ac.uk
• Status: Recruiting
• Start date: November 3, 2019
• Completion date: December 31, 2024