RecruitingNCT03586518

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

Sponsor

University of Leicester

Enrollment

9 participants

Start Date

Nov 3, 2019

Study Type

OBSERVATIONAL

Conditions

End-stage Kidney Disease Fibrosis Myocardial

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study validates a new type of heart MRI scan — one that does not require an injected contrast dye — in kidney dialysis patients who are nearing the end of life, to see if it can accurately assess heart health and predict outcomes without the risks of contrast agents. **You may be eligible if...** - You are currently on haemodialysis (kidney dialysis) for more than 3 months - You are on a supportive (palliative) care register and your doctors expect you may pass away within the next 12 months - You are able to give informed consent - You are willing to donate your heart for research after death - You can understand written and verbal explanations in English **You may NOT be eligible if...** - You have a contraindication to MRI (such as a pacemaker, incompatible metal implants, or claustrophobia) - You have or are suspected to have a condition called infiltrative cardiomyopathy (such as amyloidosis, a protein build-up in the heart) - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCardiac 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_TESTEchocardiogram

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.

PROCEDURECardiac 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_TEST48-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_TESTBlood 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.