Effects of Renal Transplantation on Uraemic Cardiomyopathy (RETRACT)

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

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 Overview

• Status: Unknown
• Conditions: Cardiomyopathies
• Intervention / Treatment: Diagnostic test: Cardiac MRI

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Luke Pickup, MBBS; Phone Number: 07828791429; Email: luke.pickup2@uhb.nhs.uk
• Study Contact Backup: Name: Charles Ferro, MD; Phone Number: 01213715839; Email: Charles.ferro@uhb.nhs.uk

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2TH
      • Recruiting
      • Queen Elizabeth Hospital
      • Contact: Luke Pickup, MBBS; Phone Number: 07828791429; Email: luke.pickup2@uhb.nhs.uk
      • Contact: Charles Ferro, MD; Phone Number: 01213715839; Email: Charles.ferro@uhb.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise of patients with end-stage renal failure currently awaiting either live or deceased donor transplantation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transplant recipients; Patients undergoing live donor kidney transplant.	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.
Non-transplanted; Patients on the deceased donor waiting list without prospect of a live donor transplant.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left Ventricular Mass	Calculated by Cardiac MRI	One year.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Birmingham NHS Foundation Trust
• Investigators: Principal Investigator: Charles Ferro, MD, University Hospital Birmingham NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: RRK6458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No