- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03704701
The Interrogation of the Cardiomyopathy of Chronic Kidney Disease With advancEd caRdiac Imaging (TICKER)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Glasgow, United Kingdom, G51 4TF
- Queen Elizabeth University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 hours
|
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.
|
Baseline
|
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).
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN17RE700
- 243630 (OTHER: Integrated Research Application System (IRAS) ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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