CardiomyopathiesRETRACTNCT03892343
Effects of Renal Transplantation on Uraemic Cardiomyopathy
An observational study of Cardiomyopathies, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cardiomyopathies
- What is being tested?
- Cardiac MRI
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Dec 2018to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will comprise of patients with end-stage renal failure currently awaiting either live or deceased donor transplantation.
Who may be able to join
- Patients registered on the kidney transplant waiting list at the University Hospital Birmingham NHS Foundation Trust.
- Ages over 18 years
Who cannot join
- Non-standard anti-rejection treatment, post transplant.
- Previous history of being unable to tolerate MRI scanner.
- Contraindication to MRI - eg metal fragments in ey
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth Hospital
Birmingham, West Midlands, B15 2TH
Luke Pickup, MBBS, 07828791429, luke.pickup2@uhb.nhs.uk
Charles Ferro, MD, 01213715839, Charles.ferro@uhb.nhs.uk
About this study
Official title: 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.
- Conditions
- Cardiomyopathies
- Being tested
- Cardiac MRI
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Transplant recipients | Patients undergoing live donor kidney transplant. Receives: Diagnostic Test: Cardiac MRI | |
| Non-transplanted | Patients on the deceased donor waiting list without prospect of a live donor transplant. Receives: Diagnostic Test: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Mass
Calculated by Cardiac MRI
Measured: One year.
Secondary outcomes (3)
Native Myocardial T1 Times.
Measured using T1 mapping techniques (MOLLI)
Measured: One year.
Blood Pressure
24hr Ambulatory Blood pressure monitoring
Measured: One year.
Pulse Wave Analysis.
To calculate augmentation index as a marker of arterial stiffness.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start5 Dec 2018
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Ferro, Dr, University Hospital Birmingham NHS Foundation Trust
- Investigators
- Charles Ferro, MD, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892343
- Sponsor's protocol ID
- RRK6458
- Acronym
- RETRACT
- Status last verified
- Mar 2019
- First submitted
- 27 Feb 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Effects of Renal Transplantation on Uraemic Cardiomyopathy Using Magnetic Resonance Imaging.
- ClinicalTrials.gov ID
- NCT03892343
- Acronym / sponsor ID
- RETRACT / RRK6458
- Conditions
- Cardiomyopathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transplant recipients | – | Diagnostic Test: Cardiac MRIPatients undergoing live donor kidney transplant. |
| Non-transplanted | – | Diagnostic Test: Cardiac MRIPatients on the deceased donor waiting list without prospect of a live donor transplant. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will comprise of patients with end-stage renal failure currently awaiting either live or deceased donor transplantation.
Key inclusion criteria (2 listed)
- Patients registered on the kidney transplant waiting list at the University Hospital Birmingham NHS Foundation Trust.
- Ages over 18 years
Key exclusion criteria (3 listed)
- Non-standard anti-rejection treatment, post transplant.
- Previous history of being unable to tolerate MRI scanner.
- Contraindication to MRI - eg metal fragments in ey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRICardiac 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. | Diagnostic test | Non-transplanted, Transplant recipients |
Primary outcome
Left Ventricular Mass
Time frame: One year.
Calculated by Cardiac MRI
3 secondary outcomes
Native Myocardial T1 Times.
Time frame: One year.
Blood Pressure
Time frame: One year.
Pulse Wave Analysis.
Time frame: One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Cardiomyopathies
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Ferro, MD principal investigator
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luke Pickup, MBBS (07828791429, luke.pickup2@uhb.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Mass (time frame: One year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.