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临床试验/NCT04107220
NCT04107220Unknown不适用

Comparison of BNP and NT-proBNP in the Management of Patients With Chronic and Acute Heart Failure

Unity Health Toronto1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Out Patient Protocol

研究概览

简要总结

The purpose of this study is to compare the changes in B-type Natriuretic Peptide (BNP) and amino-terminal fragment of proBNP (NT-proBNP) in outpatients managed in the heart failure (HF) clinic initiated on the Angiotensin Receptor Neprilysin Inhibitor (Entresto) and directly compare the prognostic values of BNP and NT-proBNP in patients admitted with acute decompensated HF.

详细描述

Both natriuretic peptides (NP), namely B-type NP (BNP) and amino-terminal fragment of proBNP (NT-proBNP), have an established role in the management of patients with heart failure (HF).[1] However, the clinical utility of BNP has recently been questioned with the PARADIGM-HF trial, which demonstrated increased BNP and reduced NT-proBNP levels following the administration of Entresto, a newly approved angiotensin receptor neprilysin inhibitor (ARNI).[2.3] The increase in BNP was thought to be reflective of reduced metabolism of BNP as a result of neprilysin inhibition.[2] However, this claim was based on observations of three points in time and with wide confidence intervals.[3] In addition, there has been no attempt to demonstrate dose relationships. Furthermore, although both BNP and NT-proBNP have each been shown to predict HF readmission in hospitalized patients [1,4,5] the relative utility between the two NPs for this prediction remains unclear. We therefore hypothesize that once beyond the initiation of ARNI therapy, BNP and NT-proBNP will be equally predictive of clinical events in patients with HF.

The studies comprise of two separate protocols:

A. Outpatient Protocol - the effect of Entresto measuring the changes in the NT-proBNP and BNP test results. This protocol will be conducted on ambulatory outpatients initiating on Entresto. Patients will have blood sampling for the measurements of BNP and NT-proBNP at baseline, at the first and second up titration in dose of Entresto, and at 6 months and 1st year after starting Entresto.

B. Inpatient Protocol-predicting outcomes. This will be conducted on patients admitted for acute decompensated HF. Blood sampling for BNP and NT-proBNP will be collected in different time points (admission, hospital discharge, 30th day, 90th day, and 180th day) and measure its changes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Out Patient Protocol - Patients with chronic heart failure being followed in the heart failure clinic eligible to switch angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) to ARNI (Entresto).
  • In Patient Protocol - Patients admitted due to acute decompensated heart failure

排除标准

  • 未提供

研究组 & 干预措施

one arm

Other

One arm study patients where NT-proBNP and BNP tests will be monitored.

干预措施: Sacubitril/Valsartan (Drug)

结局指标

主要结局

Out Patient Protocol

时间窗: Baseline, 2 weeks, 4 weeks, 6 months, and 12 months

Measuring the changes with NT-prooBNP and BNP.

In Patient Protocol

时间窗: Admission, discharge, 30th day post-discharge, 60th day post-discharge, and 180 days post discharge

Measuring the changes with NT-prooBNP and BNP.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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