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

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Chronic Kidney Diseases; Hypertrophy, Left Ventricular; Heart Failure; Cardiomyopathies

Treatments: Diagnostic Test: cardiac magnetic resonance (CMR) post haemodialysis

Study type: Observational

Funder types: Other

Identifiers

NCT03749551

TrueTypeCKD 4/17

Details and patient eligibility

About

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.

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults >18 years of age
2. Able to provide informed consent
3. Chronic kidney disease stages G3-5 (eGFR<59 ml/min/1.73m2)

Exclusion criteria

1. Absence of absolute clinical indication for MRI studies (MR unsafe or incompatible devices, aneurysm clips, cochlear implants, loose metal foreign objects)
2. Absolute contraindications to gadolinium contrast agent (previous allergic reaction or pregnancy),

Trial design

276 participants in 1 patient group

Participants

Description:

diagnostic test - patients serving as their own controls

Treatment:

Diagnostic Test: cardiac magnetic resonance (CMR) post haemodialysis