Clinical trial NCT03586518: Validating Novel, Non-contrast Cardiac MRI Imaging in Haemodialysis Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End Stage Kidney Disease
Fibrosis Myocardial
Keywords: Cardiac MRI
Hemodialysis
Myocardial Fibrosis
Myocardial Inflammation
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
name: St George's, University of London
First posted: 2018-07-13
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between MRI and histological measures of cardiac fibrosis
timeFrame: Cardiac MRI performed within 12-months of histological samples obtained post-mortem
Secondary outcomes:
measure: Accuracy of MRI versus ECHO in the measurement of cardiac fibrosis
timeFrame: Echocardiograms performed within 12-months of histological samples obtained post-mortem
measure: Relationship between cardiac fibrosis and heart rhythm
timeFrame: Continuous Holter recording performed within 12-months of histological samples obtained post-mortem
measure: Correlation between cardiac fibrosis and relevant circulating biomarkers
timeFrame: Samples collected within 12-months of histological samples obtained post-mortem
measure: Additional cardiac MRI techniques and the measurement of cardiac fibrosis
timeFrame: Cardiac MRI performed within 12-months of histological samples obtained post-mortem
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
state: Leicestershire
Study officials:
affiliation: Associate Professor in Renal Medicine
name: James Burton, DM, FRCP
role: PRINCIPAL_INVESTIGATOR
References: