Effects of Renal Transplantation on Uraemic Cardiomyopathy

• Conditions: Cardiomyopathies
• Interventions: Diagnostic Test: Cardiac MRI

• Registration Number: NCT03892343
• Lead Sponsor: University Hospital Birmingham NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-05
• Study First Submitted: 2019-02-27
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-25
• Last Update Submitted: 2019-03-25
• Study First Posted: 2019-03-27
• Last Update Posted: 2019-03-27
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients registered on the kidney transplant waiting list at the University Hospital Birmingham NHS Foundation Trust.
2. Ages over 18 years

Exclusion Criteria

1. Non-standard anti-rejection treatment, post transplant.
2. Previous history of being unable to tolerate MRI scanner.
3. Contraindication to MRI - eg metal fragments in ey

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-transplanted	Cardiac MRI	Patients on the deceased donor waiting list without prospect of a live donor transplant.
Transplant recipients	Cardiac MRI	Patients undergoing live donor kidney transplant.

Primary Outcome Measures

Name	Time	Method
Left Ventricular Mass	One year.	Calculated by Cardiac MRI

Secondary Outcome Measures

Name	Time	Method
Pulse Wave Analysis.	One Year	To calculate augmentation index as a marker of arterial stiffness.
Native Myocardial T1 Times.	One year.	Measured using T1 mapping techniques (MOLLI)
Blood Pressure	One year.	24hr Ambulatory Blood pressure monitoring

Trial Locations

Locations (1)

Queen Elizabeth Hospital; 🇬🇧 Birmingham, West Midlands, United Kingdom