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

Heart Failure Clinical Trial

— TRUE-TypeCKD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749551
• Other study ID #: TrueTypeCKD 4/17
• Status: Completed
• Start date: March 28, 2018
• Est. completion date: June 14, 2021

Study information

• Verified date: July 2023
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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),

Related Conditions & MeSH terms

• Cardiomyopathies
• Chronic Kidney Diseases
• Heart Failure
• Hypertrophy
• Hypertrophy, Left Ventricular
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• cardiac magnetic resonance (CMR) post haemodialysis
patients will undergo a second CMR scan immediately after receiving haemodialysis (native CMR study)

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital	Kerckhoff Klinik

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Arcari L, Engel J, Freiwald T, Zhou H, Zainal H, Gawor M, Buettner S, Geiger H, Hauser I, Nagel E, Puntmann VO. Cardiac biomarkers in chronic kidney disease are independently associated with myocardial edema and diffuse fibrosis by cardiovascular magnetic — View Citation

Arcari L, Hinojar R, Engel J, Freiwald T, Platschek S, Zainal H, Zhou H, Vasquez M, Keller T, Rolf A, Geiger H, Hauser I, Vogl TJ, Zeiher AM, Volpe M, Nagel E, Puntmann VO. Native T1 and T2 provide distinctive signatures in hypertrophic cardiac conditions — View Citation

Chen M, Arcari L, Engel J, Freiwald T, Platschek S, Zhou H, Zainal H, Buettner S, Zeiher AM, Geiger H, Hauser I, Nagel E, Puntmann VO. Aortic stiffness is independently associated with interstitial myocardial fibrosis by native T1 and accelerated in the p — View Citation

Valbuena-Lopez SC, Camastra G, Cacciotti L, Nagel E, Puntmann VO, Arcari L. Cardiac Imaging Biomarkers in Chronic Kidney Disease. Biomolecules. 2023 Apr 29;13(5):773. doi: 10.3390/biom13050773. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in native T1 and T2 (in msec) pre and post haemodialysis	measurement of change in magnetisation relaxation (in msec)	24 hour
Primary	survival	number of deaths	1 year
Primary	survival	number of deaths	5 year
Primary	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
Primary	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	rate of heart failure events	number of participants with heart failure death and hospitalisation due to heart failure	1 year
Secondary	rate of heart failure events	number of participants with heart failure death and hospitalisation due to heart failure	5 year