Validating the Accuracy of Novel, Non-contrast Cardiac Magnetic Resonance Imaging to Define Myocardial Fibrosis in End-stage Renal Disease Patients on Haemodialysis: the CONFIRM Study

What this Trial Is About

Researchers are studying a new non-contrast cardiac MRI technique called native T1 mapping to measure scarring in the hearts of patients with advanced kidney disease who are on haemodialysis. This imaging method may help detect myocardial fibrosis, which is scarring of the heart tissue, and the study aims to validate its accuracy by comparing MRI results with direct tissue analysis after death. This research is important because current methods for measuring heart scarring in these patients are limited. The study involves haemodialysis patients who have been on treatment for more than three months and are registered for supportive care with an expected death within 12 months. Participants will undergo a non-contrast cardiac MRI scan to assess heart structure and fibrosis, echocardiograms to evaluate heart size and function, 48-hour continuous heart rhythm monitoring, and blood sample collection to analyze biomarkers related to fibrosis. After death, a limited post-mortem will be performed to collect the heart for detailed examination to compare with imaging results. Participants will be closely monitored through these imaging and diagnostic tests, including MRI, echocardiogram, heart rhythm recording, and blood tests, all performed within 12 months before tissue collection post-mortem. The primary outcome measured is the correlation between MRI findings and actual heart tissue scarring. Secondary outcomes include comparing MRI with echocardiogram accuracy, assessing heart rhythm relationships, and analyzing biomarkers. The study involves informed consent and donation agreement for heart tissue after death and concludes with the post-mortem analysis.

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