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

ConditionsEnd Stage Kidney DiseaseFibrosis Myocardial
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Leicester

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The plans for patient recruitment were developed in partnership with our local haemodialysis patient participation and involvement group. Patients will be identified by means of a well established supportive care register for haemodialysis patients. These patients, and often their families, have engaged in discussion about end-of-life care, including discussions about limitations on care and preferred place of death.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cardiac MRI scan

    Diagnostic test

    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.

  • Echocardiogram

    Diagnostic test

    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.

  • Cardiac explantation

    Procedure/Surgery

    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.

  • 48-Hour continuous cardiac monitoring

    Diagnostic test

    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.

  • Blood samples

    Diagnostic test

    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.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: Haemodialysis patients5 interventions

Trial outcomes

Primary outcomes

1

Correlation between MRI and histological measures of cardiac fibrosis

To assess the correlation between native T1 values measured using cardiac MRI in haemodialysis patients approaching the end of their lives, with histological samples analysed post-mortem.

Time frame
Cardiac MRI performed within 12-months of histological samples obtained post-mortem

Secondary outcomes

1

Accuracy of MRI versus ECHO in the measurement of cardiac fibrosis

Relationship between integrated backscatter (measured with echocardiography) and levels of myocardial fibrosis on histology measured at post-mortem.

Time frame
Echocardiograms performed within 12-months of histological samples obtained post-mortem
2

Relationship between cardiac fibrosis and heart rhythm

Relationship between continuous Holter-monitor data and levels of myocardial fibrosis on histology measured at post-mortem.

Time frame
Continuous Holter recording performed within 12-months of histological samples obtained post-mortem
3

Correlation between cardiac fibrosis and relevant circulating biomarkers

Relationship between humoral markers of cardiac dysfunction of fibrosis and levels of myocardial fibrosis on histology measured at post-mortem

Time frame
Samples collected within 12-months of histological samples obtained post-mortem
4

Additional cardiac MRI techniques and the measurement of cardiac fibrosis

The relationship between additional, non-contrast CMR techniques and histology at post-mortem

Time frame
Cardiac MRI performed within 12-months of histological samples obtained post-mortem

Other outcomes

Sponsors and contacts

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University of Leicester

Lead sponsor

University Hospitals, Leicester

Collaborator

St George's, University of London

Collaborator

Source ClinicalTrials.gov
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