RECRUITINGOBSERVATIONAL

Validating Novel, Non-contrast Cardiac MRI Imaging in Haemodialysis 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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Prevalent haemodialysis patient (more than 3 months) - Active on the supportive care register with anticipated death in the subsequent 12 months - Able to give willing to sign a consent form - Consent to donation of heart for research following death - Able to understand written and verbal explanations in English Who Should NOT Join This Trial: - Contraindication to MRI scan (e.g. pacemaker, incompatible metallic implants, claustrophobia) - Patients with expected or potential infiltrative cardiomyopathy (e.g. amyloidosis) - Unable to give willing to sign a consent form - Unable to understand written and verbal explanations in English Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DIAGNOSTIC_TEST

Cardiac MRI scan

A non-contrast cardiac MRI (CMR) scan at 3-Tesla platform (Skyra, Siemens Medical Imaging, Erlangen, Germany). This non-contrast CMR scan will principally determine: Left ventricular (LV) mass and volumes/ejection fraction and; fibrosis using T1 mapping.

DIAGNOSTIC_TEST

Echocardiogram

Assessments will include: LV size and function as per the American Society of Echocardiography guidelines. In addition specific focus will be paid end-diastolic integrated backscatter measurements.

PROCEDURE

Cardiac explantation

A limited post-mortem will be performed to retrieve patients' hearts for preparation and storage at St George's University, London where direct comparison will be made between levels of scarring seen directly under the microscope between that on the MRI scans.

DIAGNOSTIC_TEST

48-Hour continuous cardiac monitoring

Attach continuous Holter monitor (Schiller, medilog®AR12 plus/AR4 plus/FD5 plus, Baar, Switzerland) that will start before dialysis and terminate just before the subsequent dialysis treatment 48h later.

DIAGNOSTIC_TEST

Blood samples

Collect blood samples from the arterial needle before dialysis. Approximately 30 millilitres of blood will be collected and then be pipetted into cryotubes and frozen at -80°C in an electronically monitored freezer for analysis in batches throughout the study. These samples will be used to investigate the relationship between circulating biomarkers of fibrosis, the MRI scans and the histological samples.

Locations (1)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, United Kingdom