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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03749551
Acronym
TRUE-TypeCKD
Enrollment
276
Registered
2018-11-21
Start date
2018-03-28
Completion date
2021-06-14
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTcardiac magnetic resonance (CMR) post haemodialysis

patients will undergo a second CMR scan immediately after receiving haemodialysis (native CMR study)

Sponsors

Johann Wolfgang Goethe University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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),

Design outcomes

Primary

MeasureTime frameDescription
survival1 yearnumber of deaths
rate of death due to cardiovascular causes1 yearnumber of participants died due to death due to myocardial infarction, sudden cardiac death, heart failure

Secondary

MeasureTime frameDescription
rate of heart failure events1 yearnumber of participants with heart failure death and hospitalisation due to heart failure

Other

MeasureTime frameDescription
Change in native T1 and T2 (in msec) pre and post haemodialysis24 hourmeasurement of change in magnetisation relaxation (in msec)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026