Effects of Renal Transplantation on Uraemic Cardiomyopathy

Cardiomyopathies Clinical Trial

— RETRACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03892343
• Other study ID #: RRK6458
• Status: Recruiting
• Start date: December 5, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2019
• Source: University Hospital Birmingham NHS Foundation Trust
• Contact: Luke Pickup, MBBS
• Phone: 07828791429
• Email: luke.pickup2[@]uhb.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies

Intervention

Diagnostic Test:
• Cardiac MRI
Cardiac Magnetic Resonance Imaging (Siemens Skyra 3T): will be performed using protocols and techniques already in use in our group. All CMR scan derived parameters will be analysed with the investigator blinded to treatment allocation as in previous studies.

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Birmingham NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Mass	Calculated by Cardiac MRI	One year.
Secondary	Native Myocardial T1 Times.	Measured using T1 mapping techniques (MOLLI)	One year.
Secondary	Blood Pressure	24hr Ambulatory Blood pressure monitoring	One year.
Secondary	Pulse Wave Analysis.	To calculate augmentation index as a marker of arterial stiffness.	One Year