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Clinical Trials/NCT03892343
NCT03892343
Unknown
Not Applicable

A Prospective Study of the Effects of Renal Transplantation on Uraemic Cardiomyopathy Using Magnetic Resonance Imaging.

University Hospital Birmingham NHS Foundation Trust1 site in 1 country100 target enrollmentDecember 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiomyopathies
Sponsor
University Hospital Birmingham NHS Foundation Trust
Enrollment
100
Locations
1
Primary Endpoint
Left Ventricular Mass
Last Updated
7 years ago

Overview

Brief Summary

Chronic kidney disease (CKD) is associated with a high risk of death and morbidity due to cardiovascular disease. Much of this is caused by left ventricular disease characterised by abnormal muscle thickness and scaring. This process appears to start early in the course of CKD and causes heart failure and dangerous abnormal heart rhythms. Previous work suggests that the process may be reversible by kidney transplantation but almost all of the studies are small, retrospective and lack scientific rigour. Furthermore, they almost all use echocardiography, which is inaccurate in patients with CKD. The investigators plan to perform the first large, prospective, controlled, blind-analysed study using cardiac magnetic resonance imaging to determine whether CKD associated cardiomyopathy is reversed by kidney transplantation and if so, whether factors such as blood pressure and mediators of metabolic bone disease/fibrosis are important in effecting this change. Greater understanding of the mechanisms responsible for CKD associated cardiomyopathy could lead to future strategies and treatments to improve the high cardiovascular mortality associated with this condition.

Registry
clinicaltrials.gov
Start Date
December 5, 2018
End Date
September 1, 2021
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Birmingham NHS Foundation Trust
Responsible Party
Principal Investigator
Principal Investigator

Charles Ferro, Dr

Professor Charles Ferro

University Hospital Birmingham NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • Patients registered on the kidney transplant waiting list at the University Hospital Birmingham NHS Foundation Trust.
  • Ages over 18 years
  • Exclusion Criteria
  • Non-standard anti-rejection treatment, post transplant.
  • Previous history of being unable to tolerate MRI scanner.
  • Contraindication to MRI - eg metal fragments in ey

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Left Ventricular Mass

Time Frame: One year.

Calculated by Cardiac MRI

Secondary Outcomes

  • Pulse Wave Analysis.(One Year)
  • Native Myocardial T1 Times.(One year.)
  • Blood Pressure(One year.)

Study Sites (1)

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