Effects of Renal Transplantation on Uraemic Cardiomyopathy

NCT03892343 | Unknown

• 1 other identifier: RRK6458
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathies

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Mass

  Calculated by Cardiac MRI

  One year.

Secondary Outcomes (3)

• Native Myocardial T1 Times.

  One year.

• Blood Pressure

  One year.

• Pulse Wave Analysis.

  One Year

Study Arms (2)

Transplant recipients

Patients undergoing live donor kidney transplant.

Diagnostic Test: Cardiac MRI

Non-transplanted

Patients on the deceased donor waiting list without prospect of a live donor transplant.

Diagnostic Test: Cardiac MRI

Interventions

Cardiac MRI DIAGNOSTIC_TEST

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; Transplant recipients

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust: lead

Study Sites (1)

Queen Elizabeth Hospital

Birmingham, West Midlands, B15 2TH, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Markers of CKD-MBD: - calcium, phosphate, alkaline phosphatase and PTH will be analyzed in serum by mass spectroscopy and FGF-23 will be analyzed by ELISA at 0 and 12 months.

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Charles Ferro, MD

  University Hospital Birmingham NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luke Pickup, MBBS

CONTACT

07828791429; luke.pickup2@uhb.nhs.uk

Charles Ferro, MD

CONTACT

01213715839; Charles.ferro@uhb.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Charles Ferro

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 27, 2019
• Study Start: December 5, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 27, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)