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

Last updated: April 15, 2025
Sponsor: University of Leicester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scar Tissue

Treatment

Echocardiogram

Blood samples

Cardiac explantation

Clinical Study ID

NCT03586518
0674
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Prevalent haemodialysis patient (more than 3 months)

  • Active on the supportive care register with anticipated death in the subsequent 12months

  • Able to give informed consent

  • Consent to donation of heart for research following death

  • Able to understand written and verbal explanations in English

Exclusion

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

Total Participants: 9
Treatment Group(s): 5
Primary Treatment: Echocardiogram
Phase:
Study Start date:
November 03, 2019
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University Hospitals of Leicester NHS Trust

    Leicester, Leicestershire LE5 4PW
    United Kingdom

    Active - Recruiting

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