- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03892343
Effects of Renal Transplantation on Uraemic Cardiomyopathy (RETRACT)
March 25, 2019 updated by: Charles Ferro, Dr, University Hospital Birmingham NHS Foundation Trust
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
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Transplant recipients
Patients undergoing live donor kidney transplant.
|
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.
|
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
Time Frame: One year.
|
Calculated by Cardiac MRI
|
One year.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Native Myocardial T1 Times.
Time Frame: One year.
|
Measured using T1 mapping techniques (MOLLI)
|
One year.
|
Blood Pressure
Time Frame: One year.
|
24hr Ambulatory Blood pressure monitoring
|
One year.
|
Pulse Wave Analysis.
Time Frame: One Year
|
To calculate augmentation index as a marker of arterial stiffness.
|
One Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Charles Ferro, MD, University Hospital Birmingham NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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