跳至主要内容
临床试验/NCT04061811
NCT04061811已完成不适用

Soluble Neprilysin, NT-proBNP, and Growth-Differentiation-Factor-15 as Biomarkers for Heart Failure in Dialysis Patients

Hannover Medical School2 个研究点 分布在 2 个国家目标入组 153 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
153
试验地点
2
主要终点
HF diagnosis

研究概览

简要总结

Objectives: The aim of this study is to determine whether growth differentiation factor-15 (GDF15) and circulating neprilysin (cNEP) improve the diagnosis of congestive heart failure (HF) in patients on dialysis.

Background: Dialysis patients are at increased risk of HF. However, diagnostic utility of NT-proBNP as a biomarker is decreased in patients on dialysis. GDF15 and cNEP are biomarkers of distinct mechanisms that may contribute to HF pathophysiology in such cohorts.

Methods: We compare circulating concentrations of NT-proBNP, GDF15, and cNEP along with NEP activity in patients on chronic dialysis without and with HF, as diagnosed by clinical parameters and post-dialysis echocardiography. We use correlation, linear and logistic regression as well as receiver operating characteristic (ROC) analyses.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • ESRD on either chronic hemodialysis (HD) or peritoneal dialysis (PD) for ≥3 months

排除标准

  • previous switch of the type of renal replacement therapy from HD to PD or vice versa
  • age <18 years
  • pregnancy
  • plasma exchange or apheresis in the past 6 months
  • unipolar pacemaker
  • history of whole extremity amputation

结局指标

主要结局

HF diagnosis

时间窗: Baseline (at study entry (diagnostic biomarker study))

Diagnosis of HF

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Sören Balzer

Postdoctoral fellow

Hannover Medical School

研究点 (2)

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