NCT03749551: TRUE-TypeCKD

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

Completed Last updated 6 January 2026

What this trial tests

trial testing cardiac magnetic resonance (CMR) post haemodialysis in Heart Failure in 276 participants. Completed in 14 June 2021.

Timeline

28 March 2018

Primary endpoint
14 June 2021

14 June 2021

Quick facts

Lead sponsor	Johann Wolfgang Goethe University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	276
Start date	28 March 2018
Primary completion	14 June 2021
Estimated completion	14 June 2021
Sites	1 location across Germany

Drugs / interventions tested

• cardiac magnetic resonance (CMR) post haemodialysis

Conditions studied

• Heart Failure — all drugs for Heart Failure →
• Cardiomyopathies — all drugs for Cardiomyopathies →
• Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →
• Hypertrophy, Left Ventricular — all drugs for Hypertrophy, Left Ventricular →

Sponsor

Johann Wolfgang Goethe University Hospital

Who can join

18 and older, any sex, with Heart Failure or Cardiomyopathies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cardiac biomarkers in chronic kidney disease are independently associated with myocardial edema and diffuse fibrosis by cardiovascular magnetic resonance.
   Arcari L, Engel J, Freiwald T, Zhou H, et al · · 2021 · cited 29× · PMID 34092229 · DOI 10.1186/s12968-021-00762-z
2. Aortic stiffness is independently associated with interstitial myocardial fibrosis by native T1 and accelerated in the presence of chronic kidney disease.
   Chen M, Arcari L, Engel J, Freiwald T, et al · · 2019 · cited 13× · PMID 31304234 · DOI 10.1016/j.ijcha.2019.100389
3. Chronic kidney disease with elevated myocardial native T1 - Is this only due to myocardial fibrosis?
   Ng MY, Yap PM, Yiu KH. · · 2019 · cited 1× · PMID 31372491 · DOI 10.1016/j.ijcha.2019.100403