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

NCT03586518 | Recruiting

• 1 other identifier: 0674
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Kidney Disease; Fibrosis Myocardial

Keywords

Cardiac MRI; Hemodialysis; Myocardial Fibrosis; Myocardial Inflammation

Outcome Measures

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.

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

Secondary Outcomes (4)

• Accuracy of MRI versus ECHO in the measurement of cardiac fibrosis

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

• Relationship between cardiac fibrosis and heart rhythm

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

• Correlation between cardiac fibrosis and relevant circulating biomarkers

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

• Additional cardiac MRI techniques and the measurement of cardiac fibrosis

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

Study Arms (1)

Haemodialysis patients

The plans for patient recruitment were developed in partnership with our local haemodialysis patient participation and involvement group. Patients will be identified from the supportive care register established for haemodialysis patients in Leicester in 2008. Inclusion: * 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: * 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

Diagnostic Test: Cardiac MRI scan; Diagnostic Test: Echocardiogram; Procedure: Cardiac explantation; Diagnostic Test: 48-Hour continuous cardiac monitoring; Diagnostic Test: Blood samples

Interventions

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.

Also known as: CMR

Haemodialysis patients

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.

Also known as: ECHO

Haemodialysis patients

Cardiac explantation PROCEDURE

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.

Haemodialysis patients

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.

Also known as: Holter

Haemodialysis patients

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.

Haemodialysis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator
• St George's, University of London: collaborator

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE5 4PW, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Patient hearts explanted post-mortem

MeSH Terms

Conditions

Kidney Failure, Chronic; Myocarditis

Interventions

Echocardiography; Electrocardiography, Ambulatory; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrocardiography; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• James Burton, DM, FRCP

  Associate Professor in Renal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Burton, DM, FRCP

CONTACT

+44 (0)116 2588043; jb343@le.ac.uk

Matthew Graham-Brown, MBChB, MRCP

CONTACT

+44 (0)116 2588043; mgb23@le.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 13, 2018
• Study Start: November 3, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The protocol will be published within 12 months of registration.
• Access Criteria: Open access.

Locations

GB (1)