Chronic Kidney DiseasesTICKERNCT03704701
The Interrogation of the Cardiomyopathy of Chronic Kidney Disease With advancEd caRdiac Imaging
An observational study of Chronic Kidney Diseases and Cardiomyopathies, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Patients with kidney failure have a much higher risk of heart disease compared to people of the same age without kidney failure. The reason for this is not fully understood. In this project we will use Cardiac MRI (CMR), which is a very detailed scan of the heart and blood vessels, to try to better understand the… Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Chronic Kidney Diseases, Cardiomyopathies, Cardiovascular Diseases
- What is being tested?
- Cardiac MRI and contrast-enhanced cardiac CT
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2018to 5 Aug 2020
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients established on regular hospital-based haemodialysis, with evidence of recurrent fluid overload requiring fluid removal by ultrafiltration on dialysis.
Who may be able to join
- Age 40-100 years at time of recruitment.
- Established on regular day-time, hospital-based haemodialysis for >6 months.
- History of recurrent fluid overload, defined as a mean of >1.5 litres fluid removal per dialysis session from an average of 3 consecutive sessions.
- No previous clinical diagnosis of heart failure, or if previous clinical diagnosis of heart failure then must have preserved left ventricular function (ejection fraction >50% or reported as 'normal' or (similar)) on most recent transthoracic echo.
- Ability to comply with study procedures, including ability to lie flat for up to 1 hour.
- Ability to give informed consent.
Who cannot join
- Standard contra-indications to MRI, including the presence of certain metallic objects in the body (e.g. non-MRI compatible cardiac devices, previous cranial surgery with ferromagnetic clips, metal fragments in eye, etc.) and severe claustrophobia.
- Known allergy to iodinated radiological contrast.
- Asthma (unless previous CT with contrast administration within the past 12 months without adverse effect).
- Pregnancy, lactation or women of child-bearing potential not willing to use highly effective contraception for the duration of the study.
- Any other reason considered by a study physician to make the subject inappropriate for inclusion.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth University Hospital
Glasgow, G51 4TF
About this study
Patients with kidney failure have a much higher risk of heart disease compared to people of the same age without kidney failure. The reason for this is not fully understood. In this project we will use Cardiac MRI (CMR), which is a very detailed scan of the heart and blood vessels, to try to better understand the cardiovascular changes that occur in kidney failure. We will perform CMR scans in 30 patients before and after dialysis (a treatment for patients with kidney failure) to see whether dialysis changes the heart muscle. The same patients will also undergo another type of heart scan, called a CT scan. This will allow us to compare the pictures from the 2 different types of scan to help us better understand any damage to the heart muscle that is present. Finally, we will test a new way to measure hardening of blood vessels on CMR. These three studies will help us to better understand the heart and blood vessel changes that happen in kidney failure. This research will also be useful for patients without kidney failure. We hope to be able to use it in the future to see which new treatments might be able to reduce the risk of heart disease in patients with kidney failure.
Read the detailed description
Background: Patients with chronic kidney disease (CKD) are at a dramatically increased risk of cardiovascular disease. This risk is greatest in patients on dialysis and is not explained by conventional cardiovascular risk factors. Myocardial fibrosis, so called Cardiomyopathy of CKD (CM-CKD), in conjunction with excessive arterial calcification, forms the pathological basis for this excess risk. Due to limitations of using myocardial biopsy, combined with the inability to use gadolinium-enhanced imaging in patients with advanced CKD, there is an urgent need for reliable non-invasive ways of diagnosing and investigating CM-CKD.
Study participants: Adult patients established on regular hospital-based haemodialysis, with evidence of recurrent fluid overload requiring fluid removal by ultrafiltration on dialysis.
Study design: This is a single centre observational study. We will perform cardiac MRI (CMR), contrast CT and blood tests in 30 patients before haemodialysis, with a repeat CMR and blood tests post-dialysis.
Objectives: To assess:
- If myocardial native T1 mapping on CMR is affected by fluid status and therefore test the validity of T1 mapping as a marker of fibrosis within the dialysis population?
- If contrast-enhanced dynamic-equilibrium CT can refine insights into the myocardium in CM-CKD?
- If novel CMR methods can effectively identify and delineate arterial calcification compared to CT?
Relevance: This project will have immediate clinical relevance by clarifying key questions in the diagnosis and investigation of CM-CKD. It will also inform as to the potential role for these novel imaging biomarkers as surrogate end-points for use in future clinical trials exploring disease specific drug therapies.
- Being tested
- Cardiac MRI and contrast-enhanced cardiac CT
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiomyopathies, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRI and contrast-enhanced cardiac CTDiagnostic test
Cardiac MRI Contrast-enhanced cardiac CT
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1A: Myocardial native T1 in response to changing fluid status
Change in myocardial native T1 mapping (MOLLI) on cardiac MRI at visit 2, compared to visit 1, following removal of excess fluid by ultrafiltration.
Measured: 24 hours
Part 1B: Measurement of myocardial extracellular volume by CT (ECV-CT)
Comparison between myocardial extracellular volume on contrast-enhanced CT and myocardial native T1 times measured on cardiac MRI.
Measured: Baseline
Part 1C: Vascular calcification on MRI
Comparison between Cardiac MRI and CT to detect the presence or absence of vascular calcification within the thoracic aorta at the level of the right pulmonary artery (PA).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start10 Oct 2018
- Primary completion5 Aug 2020
- Study completion5 Aug 2020
Why it stopped: COVID-19 pandemic; pre-pandemic recruitment sufficient for scientific validity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alastair J Rankin, MBChB, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704701
- Sponsor's protocol ID
- GN17RE700
- Other IDs
- 243630
- Acronym
- TICKER
- Status last verified
- Feb 2022
- First submitted
- 10 Oct 2018
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interrogation of the Cardiomyopathy of Chronic Kidney Disease With advancEd caRdiac Imaging
- ClinicalTrials.gov ID
- NCT03704701
- Acronym / sponsor ID
- TICKER / GN17RE700
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic; pre-pandemic recruitment sufficient for scientific validity
- Enrolment
- 28 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 15 Oct 2018 (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.
Patients with kidney failure have a much higher risk of heart disease compared to people of the same age without kidney failure. The reason for this is not fully understood. In this project we will use Cardiac MRI (CMR), which is a very detailed scan of the heart and blood vessels, to try to better understand the cardiovascular changes that occur in kidney failure. We will perform CMR scans in 30 patients before and after dialysis (a treatment for patients with kidney failure) to see whether dialysis changes the heart muscle. The same patients will also undergo another type of heart scan, called a CT scan. This will allow us to compare the pictures from the 2 different types of scan to help us better understand any damage to the heart muscle that is present. Finally, we will test a new way to measure hardening of blood vessels on CMR. These three studies will help us to better understand the heart and blood vessel changes that happen in kidney failure. This research will also be useful for patients without kidney failure. We hope to be able to use it in the future to see which new treatments might be able to reduce the risk of heart disease in patients with kidney failure.
Detailed description
Background: Patients with chronic kidney disease (CKD) are at a dramatically increased risk of cardiovascular disease. This risk is greatest in patients on dialysis and is not explained by conventional cardiovascular risk factors. Myocardial fibrosis, so called Cardiomyopathy of CKD (CM-CKD), in conjunction with excessive arterial calcification, forms the pathological basis for this excess risk. Due to limitations of using myocardial biopsy, combined with the inability to use gadolinium-enhanced imaging in patients with advanced CKD, there is an urgent need for reliable non-invasive ways of diagnosing and investigating CM-CKD.
Study participants: Adult patients established on regular hospital-based haemodialysis, with evidence of recurrent fluid overload requiring fluid removal by ultrafiltration on dialysis.
Study design: This is a single centre observational study. We will perform cardiac MRI (CMR), contrast CT and blood tests in 30 patients before haemodialysis, with a repeat CMR and blood tests post-dialysis.
Objectives: To assess:
- If myocardial native T1 mapping on CMR is affected by fluid status and therefore test the validity of T1 mapping as a marker of fibrosis within the dialysis population?
- If contrast-enhanced dynamic-equilibrium CT can refine insights into the myocardium in CM-CKD?
- If novel CMR methods can effectively identify and delineate arterial calcification compared to CT?
Relevance: This project will have immediate clinical relevance by clarifying key questions in the diagnosis and investigation of CM-CKD. It will also inform as to the potential role for these novel imaging biomarkers as surrogate end-points for use in future clinical trials exploring disease specific drug therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients established on regular hospital-based haemodialysis, with evidence of recurrent fluid overload requiring fluid removal by ultrafiltration on dialysis.
Key inclusion criteria (6 listed)
- Age 40-100 years at time of recruitment.
- Established on regular day-time, hospital-based haemodialysis for >6 months.
- History of recurrent fluid overload, defined as a mean of >1.5 litres fluid removal per dialysis session from an average of 3 consecutive sessions.
- No previous clinical diagnosis of heart failure, or if previous clinical diagnosis of heart failure then must have preserved left ventricular function (ejection fraction >50% or reported as 'normal' or (similar)) on most recent transthoracic echo.
- Ability to comply with study procedures, including ability to lie flat for up to 1 hour.
Key exclusion criteria (5 listed)
- Standard contra-indications to MRI, including the presence of certain metallic objects in the body (e.g. non-MRI compatible cardiac devices, previous cranial surgery with ferromagnetic clips, metal fragments in eye, etc.) and severe claustrophobia.
- Known allergy to iodinated radiological contrast.
- Asthma (unless previous CT with contrast administration within the past 12 months without adverse effect).
- Pregnancy, lactation or women of child-bearing potential not willing to use highly effective contraception for the duration of the study.
- Any other reason considered by a study physician to make the subject inappropriate for inclusion.
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 MRI and contrast-enhanced cardiac CTCardiac MRI Contrast-enhanced cardiac CT | Diagnostic test | – |
Primary outcome
Part 1A: Myocardial native T1 in response to changing fluid status
Time frame: 24 hours
Change in myocardial native T1 mapping (MOLLI) on cardiac MRI at visit 2, compared to visit 1, following removal of excess fluid by ultrafiltration.
Part 1B: Measurement of myocardial extracellular volume by CT (ECV-CT)
Time frame: Baseline
Comparison between myocardial extracellular volume on contrast-enhanced CT and myocardial native T1 times measured on cardiac MRI.
Part 1C: Vascular calcification on MRI
Time frame: Baseline
Comparison between Cardiac MRI and CT to detect the presence or absence of vascular calcification within the thoracic aorta at the level of the right pulmonary artery (PA).
Results and safety
The study was stopped early (reason given: COVID-19 pandemic; pre-pandemic recruitment sufficient for scientific validity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Alastair J Rankin, MBChB principal investigator
University of Glasgow
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 Chronic Kidney Diseases and Cardiomyopathies, run by NHS Greater Glasgow and Clyde 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 Feb 2022. 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?
The study was stopped early (reason given: COVID-19 pandemic; pre-pandemic recruitment sufficient for scientific validity). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1A: Myocardial native T1 in response to changing fluid status (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 21 Feb 2022.