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

Completed

• Conditions: Cardiomyopathies; Heart Failure; Chronic Kidney Diseases; Hypertrophy, Left Ventricular
• Interventions: Diagnostic Test: cardiac magnetic resonance (CMR) post haemodialysis

• Registration Number: NCT03749551
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-28
• Study First Submitted: 2018-11-17
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-21
• Primary Completion: 2021-06-14
• Study Completion: 2021-06-14
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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),

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	cardiac magnetic resonance (CMR) post haemodialysis	diagnostic test - patients serving as their own controls

Primary Outcome Measures

Name	Time	Method
survival	5 year	number of deaths
rate of death due to cardiovascular causes	5 year	number of participants died due to death due to myocardial infarction, sudden cardiac death, heart failure

Secondary Outcome Measures

Name	Time	Method
rate of heart failure events	5 year	number of participants with heart failure death and hospitalisation due to heart failure

Trial Locations

Locations (1)

University Hospital Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany