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Effects of Renal Transplantation on Uraemic Cardiomyopathy (RETRACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03892343
Recruitment Status : Unknown
Verified March 2019 by Charles Ferro, Dr, University Hospital Birmingham NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Charles Ferro, Dr, University Hospital Birmingham NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment
Cardiomyopathies Diagnostic Test: Cardiac MRI

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of the Effects of Renal Transplantation on Uraemic Cardiomyopathy Using Magnetic Resonance Imaging.
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Left Ventricular Mass [ Time Frame: One year. ]
    Calculated by Cardiac MRI


Secondary Outcome Measures :
  1. Native Myocardial T1 Times. [ Time Frame: One year. ]
    Measured using T1 mapping techniques (MOLLI)

  2. Blood Pressure [ Time Frame: One year. ]
    24hr Ambulatory Blood pressure monitoring

  3. Pulse Wave Analysis. [ Time Frame: One Year ]
    To calculate augmentation index as a marker of arterial stiffness.


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.

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892343


Contacts
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Contact: Luke Pickup, MBBS 07828791429 luke.pickup2@uhb.nhs.uk
Contact: Charles Ferro, MD 01213715839 Charles.ferro@uhb.nhs.uk

Locations
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United Kingdom
Queen Elizabeth Hospital Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Contact: Luke Pickup, MBBS    07828791429    luke.pickup2@uhb.nhs.uk   
Contact: Charles Ferro, MD    01213715839    Charles.ferro@uhb.nhs.uk   
Sponsors and Collaborators
University Hospital Birmingham NHS Foundation Trust
Investigators
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Principal Investigator: Charles Ferro, MD University Hospital Birmingham NHS Foundation Trust
More Information
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Responsible Party: Charles Ferro, Dr, Professor Charles Ferro, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03892343    
Other Study ID Numbers: RRK6458
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases