Body Composition Monitoring in Valvular Heart Disease: Association With Clinical Status and Impact on Prognosis
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
- Establish a database reflecting the fluid status assessed by BCM of patients presenting with valvular heart disease according to current guidelines
- Monitor fluid status assessed by BCM during increased diuretic treatment in patients presenting with cardiac decompensation due to valvular heart disease
- 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
- 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
- 否
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
Dr. Andreas Kammerlander
MD
Medical University of Vienna
