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

RecruitingOBSERVATIONAL
Enrollment

9

Participants

Timeline

Start Date

November 3, 2019

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
End Stage Kidney DiseaseFibrosis Myocardial
Interventions
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.

Trial Locations (1)

LE5 4PW

RECRUITING

University Hospitals of Leicester NHS Trust, Leicester

All Listed Sponsors
collaborator

University Hospitals, Leicester

OTHER

collaborator

St George's, University of London

OTHER

lead

University of Leicester

OTHER