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临床试验/NCT01570153
NCT01570153已完成不适用

Biomarkers Plus Bioimpedance Vector Analysis to Predict Cardiorenal Syndrome Onset and Prognosis in Patients With Acutely Decompensated Heart Failure: Biomonitoring and Cardiorenal Syndrome in Heart Failure(BIONICS-HF) Trial

Massachusetts General Hospital2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
the onset of Worsening renal function following admission

研究概览

简要总结

The purpose of this study is to evaluate the ability of a non-invasive monitor that measures how much fluid is in the body as well as various blood tests for their ability to predict worsening kidney function in patients with heart failure.

详细描述

Our specific aims are to:

  1. Evaluate the individual and collective ability of pro-B type natriuretic peptide (NT-pro-BNP), soluble (s)ST2, neutrophil gelatinase-associated lipocalin (NGAL), and bioelectrical impedance vector analysis (BIVA) for predicting in-hospital worsening renal function (WRF) in patients evaluated in emergency department (ED)with acutely decompensated heart failure (ADHF)compared to a model of clinical variables alone.
  2. Evaluate the individual and collective ability of NT-proBNP, sST2, NGAL, and BIVA for identifying the correct cause of in-hospital WRF in patients evaluated in the ED with ADHF.
  3. Evaluate the individual and collective ability of NT-pro-BNP, sST2, NGAL, and BIVA for predicting outcomes (all-cause death, all-cause re-hospitalization, initiation of renal replacement therapy by 180 days) in patients with ADHF.

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

  • Dyspnea thought to be due to ADHF
  • NYHA class III or IV symptoms

排除标准

  • renal failure requiring renal replacement therapy rior to enrollment
  • unable or unwilling to participate
  • > 6 hours from first dose of intravenous diuretic

结局指标

主要结局

the onset of Worsening renal function following admission

时间窗: From beginning of hospitalization to a follow up of 60 days

次要结局

  • all cause mortality(From beginning of hospitalization to a follow up of 60 days)
  • the initiation of renal replacement therapy(From beginning of hospitalization to a follow up of 60 days)

研究者

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

James L. Januzzi

JANUZZI, JAMES L, MD CARDIOLOGY DIVISION CARDIAC UNIT ASSOCIATES DIRECTOR CARDIAC CARE UNIT

Massachusetts General Hospital

研究点 (2)

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