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

Recruiting

• Conditions: Fibrosis Myocardial; End Stage Kidney Disease
• Interventions: Diagnostic Test: Cardiac MRI scan; Diagnostic Test: Echocardiogram; Procedure: Cardiac explantation; Diagnostic Test: 48-Hour continuous cardiac monitoring; Diagnostic Test: Blood samples

• Registration Number: NCT03586518
• Lead Sponsor: University of Leicester

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.

Detailed Description

Native T1 mapping is a novel, non-contrast, cardiac MRI technique that characterises myocardial tissue by exploiting the different water content of tissues. It correlates well with histo-pathological levels of myocardial fibrosis in diseases of pressure overload such as aortic stenosis. There is growing evidence to demonstrate the potential of native T1 mapping as an imaging biomarker of myocardial fibrosis in patients with ESRD; myocardial native T1 values are higher in patients with ESRD than controls, and associate with measures of myocardial strain and circulating markers of cardiac dysfunction. Although native T1 times are affected by water content of tissues, our group has shown that native T1 times are not influenced by clinical changes in fluid status in HD patients and that the inter-study reproducibility and intra- and inter-observer variability of native T1 are outstanding.

Native T1 mapping is a promising, non-invasive imaging biomarker of myocardial fibrosis in patients with advanced renal disease. It is essential that the technique is validated against histology before further use in clinical studies.

The aim of this study is to directly assess the relationship between native T1 mapping and levels of MF examined at post-mortem in haemodialysis patients.

Study Timeline

• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-13
• Study Start: 2019-11-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Haemodialysis patients	Echocardiogram	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
Haemodialysis patients	48-Hour continuous cardiac monitoring	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
Haemodialysis patients	Cardiac MRI scan	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
Haemodialysis patients	Cardiac explantation	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
Haemodialysis patients	Blood samples	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

Primary Outcome Measures

Name	Time	Method
Correlation between MRI and histological measures of cardiac fibrosis	Cardiac MRI performed within 12-months of histological samples obtained post-mortem	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.

Secondary Outcome Measures

Name	Time	Method
Additional cardiac MRI techniques and the measurement of cardiac fibrosis	Cardiac MRI performed within 12-months of histological samples obtained post-mortem	The relationship between additional, non-contrast CMR techniques and histology at post-mortem
Accuracy of MRI versus ECHO in the measurement of cardiac fibrosis	Echocardiograms performed within 12-months of histological samples obtained post-mortem	Relationship between integrated backscatter (measured with echocardiography) and levels of myocardial fibrosis on histology measured at post-mortem.
Relationship between cardiac fibrosis and heart rhythm	Continuous Holter recording performed within 12-months of histological samples obtained post-mortem	Relationship between continuous Holter-monitor data and levels of myocardial fibrosis on histology measured at post-mortem.
Correlation between cardiac fibrosis and relevant circulating biomarkers	Samples collected within 12-months of histological samples obtained post-mortem	Relationship between humoral markers of cardiac dysfunction of fibrosis and levels of myocardial fibrosis on histology measured at post-mortem

Trial Locations

Locations (1)

University Hospitals of Leicester NHS Trust; 🇬🇧 Leicester, Leicestershire, United Kingdom