跳至主要内容
临床试验/NCT03749551
NCT03749551已完成不适用

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

Johann Wolfgang Goethe University Hospital1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2018年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
276
试验地点
1
主要终点
survival

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

survival

时间窗: 5 year

number of deaths

rate of death due to cardiovascular causes

时间窗: 5 year

number of participants died due to death due to myocardial infarction, sudden cardiac death, heart failure

survival

时间窗: 1 year

number of deaths

rate of death due to cardiovascular causes

时间窗: 1 year

number of participants died due to death due to myocardial infarction, sudden cardiac death, heart failure

次要结局

  • rate of heart failure events(5 year)
  • rate of heart failure events(1 year)

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Valentina Puentmann

Principal Investigator

Johann Wolfgang Goethe University Hospital

研究点 (1)

Loading locations...

相似试验