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临床试验/NCT06691477
NCT06691477已完成不适用

A Cut-off Value Study of N-terminal Brain Natriuretic Peptide (Chemiluminescence Method)

Beckman Coulter, Inc.4 个研究点 分布在 1 个国家目标入组 1,104 人开始时间: 2023年4月10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
1,104
试验地点
4
主要终点
Diagnostic accuracy: Sensitivity and specificity

研究概览

简要总结

The aim of the study is to evaluate diagnostic performance of N-terminal Brain natriuretic Peptide (NT-proBNP) in acute heart failure among Chinese population. Further, it sought to explore the optimal cut-off point fitting Chinese patients.

详细描述

Heart failure (HF) is a complex clinical syndrome characterized by dyspnea, fatigue, and fluid retention (pulmonary congestion, systemic congestion, and peripheral edema) caused by abnormal changes in the structure and/or function of the heart due to multiple causes, resulting in dysfunctional ventricular contraction and/or diastolic function [1]. Heart failure is a severe or advanced stage of various cardiac diseases, with high rates of mortality and rehospitalization [1]. The prevalence of heart failure in developed countries is 1.5%~2.0%, and the prevalence in ≥ 70-year-old population ≥ 10%[2]. According to the epidemiological survey in 2003, the prevalence of heart failure in adults aged 35~74 years in China was 0.9% [3]. In recent years, with the aging of the population, the prevalence of heart failure in China has continued to increase.

A comprehensive and accurate diagnosis is a prerequisite for effective treatment for patients with heart failure, but patients with heart failure often have multiple diseases, and the clinical symptoms of heart failure overlap with those of chronic obstructive pulmonary disease and asthma, making it difficult to make clinical differential diagnosis [1]. At present, a variety of biomarkers have been used in the clinical diagnosis of heart failure, among which brain natriuretic peptide (BNP)/aminoterminal brain natriuretic peptide precursor (NT-proBNP) is the best biomarker for diagnosing heart failure [4].

Natriuretic peptides are a class of endogenous polypeptides with natriuretic and diuretic effects. BNP is an important natriuretic peptide in the human body, which is very sensitive and specifically reflects cardiac dysfunction, and has important clinical significance [5,6]. BNP is mainly synthesized by the ventricles, and when myocardial cells are stimulated, they produce a 134-amino acid B-type natriuretic peptide precursor, followed by a 108-amino acid BNP precursor, which is cleaved by the action of an endonuclease into a 76-amino acid, non-biologically active NT-proBNP, and a 32-amino acid-containing active BNP, which are released into the bloodstream [6].

Currently, blood BNP levels have been recommended by several international authoritative societies, including the American College of Cardiology Foundation/American Heart Association (ACCF/AHA), and the European Society of Cardiology (ESC), as a diagnostic and prognostic indicator of heart failure [7-10].

NT-proBNP and BNP belong to the same natriuretic peptide family and have the same biological origin. Because NT-proBNP and BNP are equimolar releases, they have similar clinical applications in the diagnosis, treatment, monitoring, and prognosis of cardiovascular diseases [5].

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

  • Age: ≥ 18 years old to voluntarily participate in this study and sign the informed consent form.
  • Subjects Remaining serum or plasma sample size > 500 ml.
  • Have symptoms that would make the investigator suspect that they are related to heart failure.
  • Dyspneic patients presenting to 3 EDs in China were enrolled and had sufficient blood for subsequent NT-proBNP measurement.

排除标准

  • Chronic kidney disease stage 4 or
  • Chronic renal dialysis.
  • Participation in clinical studies that may interfere with participation in this study;
  • Any behavior that would increase the subject's risk or prevent the subject from fully complying with or completing this study;
  • The sample size is not enough for testing;
  • Hemolysis, lipidemia or jaundice may be visible to the naked eye in the sample.

结局指标

主要结局

Diagnostic accuracy: Sensitivity and specificity

时间窗: Baseline

This study aims to evaluate the diagnostic performance of NT-proBNP for acute HF in patients with dyspnea in emergency department setting.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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