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临床试验/NCT03371394
NCT03371394Unknown不适用

Body Composition Monitoring in Valvular Heart Disease: Association With Clinical Status and Impact on Prognosis

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年12月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Cardiovascular outcome

研究概览

简要总结

By bioelectrical impedance spectroscopy (BIS) association of fluid status in patients with valvular heart disease and cardiovascular outcome will be assessed.

详细描述

Volume overload and abnormal fluid distribution are hallmarks in the syndromes of acute and chronic heart failure (HF) as well as valvular heart disease (VHD). Most patients, at some point in their disease progression, present acutely to an emergency department, where they will typically show symptoms of progressive volume overload.

Most patients respond well to standard diuretic therapy, usually at the costs of impaired renal function. Based on the assumption that clinically overt fluid overload is the result of progressive fluid accumulation, current European Society of Cardiology (ESC) and American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines recommend a correction of volume status using diuretics, to reduce the total fluid volume. However there is no consensus on how to define fluid overload quantitavely.

In patients undergoing dialysis, bioelectrical impedance spectroscopy / body composition monitoring (BCM) is a well established tool to assess fluid status, allowing quantitative measurement.

This study aims to

  1. Establish a database reflecting the fluid status assessed by BCM of patients presenting with valvular heart disease according to current guidelines
  2. Monitor fluid status assessed by BCM during increased diuretic treatment in patients presenting with cardiac decompensation due to valvular heart disease
  3. Assess the association between severity of valvular heart disease assessed by echocardiography and/or cardiac magnetic resonance imaging, fluid status assessed by BCM, and clinical as well as laboratory parameters assessed during clinical routine
  4. Assess the relationship between fluid status assessed by BCM and cardiovascular outcome

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

  • Valvular stenosis and/or regurgitation of all severities as defined by current recommendations
  • informed consent
  • willingness to perform follow up visit

排除标准

  • <18 years old
  • pregnancy
  • unwillingness to paricipate

结局指标

主要结局

Cardiovascular outcome

时间窗: 3 years

composition of hospitalization due to heart failure and cardiovascular death

次要结局

  • Severity of valvular heart disease(baseline)
  • Clinical status (NYHA functional class)(baseline)
  • NT-proBNP(baseline)
  • Renal impairment(baseline)

研究者

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

Dr. Andreas Kammerlander

MD

Medical University of Vienna

研究点 (1)

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