Towards Understanding the Phenotype of Cardiovascular Disease in CKD - TRUE-Type-CKD Study

Study Overview
=================
Brief Summary
-----------------
Premature cardiovascular disease (CVD) is the leading cause of death in patients with kidney disease (CKD). Excessive cardiac mortality is thought to be secondary to non-atherosclerotic processes, with left ventricular (LV) hypertrophy (LVH) and remodelling being the predominant phenotypical features. Along with other risk factors, subclinical ischaemia and haemodynamic perturbations associated with haemodialysis (HD) are thought to contribute to the ultimate development of LV systolic and diastolic dysfunction. The development of these adverse features reflects a specific cardiomyopathy due to CKD and subsequently, to uraemia. Patients receiving hemodialysis (HD) have a higher incidence rate of heart failure (predominantly with preserved ejection fraction), with phenotypically eccentric hypertrophic remodelling, systolic and diastolic dysfunction as well as high rate of interstitial myocardial fibrosis. Detection and ultimately reversal of the development of this CKD-related cardiomyopathy are important goals for improving the CVD, morbidity and mortality of CKD patients.The objectives of this study are, firstly, to investigate the complex myocardial phenotype in patients with various stages of CKD, secondly, to relate the CMR-measures to outcome, and thirdly, to be able to estimate the effects of chronic uremia/hypervolemia. Deciphering the predominant driver of remodelling on an individual level may help to personalise anti-remodelling strategies. Native T1 and T2 mapping imaging provide non-invasive imaging tools to detect myocardial fibrosis and oedema, respectively. Prognostic associations of these measures may clarify the relative prevalence of adverse phenotype and their relative contribution to adverse events and poor outcome. The role of chronic water retention and uraemia may be associated with interstitial myocardial oedema promoting further the remodelling process.

Official Title
-----------------
TowaRds Understanding the phEnoTYPEs of Cardiovascular Dysfunction in Patients With Chronic Kidney Disease and HaemoDialysis Using Cardiovascular Magnetic Resonance Imaging - TRUE-Type-CKD Study

Conditions
-----------------
Heart Failure, Cardiomyopathies, Chronic Kidney Diseases, Hypertrophy, Left Ventricular

Intervention / Treatment
-----------------
* Diagnostic Test: cardiac magnetic resonance (CMR) post haemodialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults >18 years of age Able to provide informed consent Chronic kidney disease stages G3-5 (eGFR<59 ml/min/1.73m2) Exclusion Criteria: Absence of absolute clinical indication for MRI studies (MR unsafe or incompatible devices, aneurysm clips, cochlear implants, loose metal foreign objects) Absolute contraindications to gadolinium contrast agent (previous allergic reaction or pregnancy),

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>diagnostic test - patients serving as their own controls | Diagnostic Test: cardiac magnetic resonance (CMR) post haemodialysis<br>* patients will undergo a second CMR scan immediately after receiving haemodialysis (native CMR study)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | number of deaths | 1 year | 
| survival | number of deaths | 5 year | 
| rate of death due to cardiovascular causes | number of participants died due to death due to myocardial infarction, sudden cardiac death, heart failure | 1 year | 
| rate of death due to cardiovascular causes | number of participants died due to death due to myocardial infarction, sudden cardiac death, heart failure | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of heart failure events | number of participants with heart failure death and hospitalisation due to heart failure | 1 year | 
| rate of heart failure events | number of participants with heart failure death and hospitalisation due to heart failure | 5 year |