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Clinical Trials/NCT03892343
NCT03892343UnknownNot 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 enrollmentStarted: December 5, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Left Ventricular Mass

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.)

Investigators

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

Charles Ferro, Dr

Professor Charles Ferro

University Hospital Birmingham NHS Foundation Trust

Study Sites (1)

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