NCT02791074已完成不适用
Non-invasive Determination of Intra-left Ventricular Pressure-time Profile for Diagnosis of Heart Failure With Normal and Reduced Ejection Fraction.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- First occurrence of cardiovascular event
研究概览
简要总结
This proposed study aim to:
- Determine intra-LV pressure-time profile non-invasively using recently developed echo Doppler VFM analysis and applanation tonometry and myocardial elastic properties, in HF subjects (both HFNEF and HFREF) compared to normal volunteers.
- Correlate calculated intra-LV pressure parameters with NT ProBNP levels.
详细描述
Heart failure (HF) is a common disease and its syndrome is difficult to diagnose. HF with reduced ejection fraction (HFREF) may be diagnosed based on impaired LVEF (<50%). However, diagnosis of HF with normal ejection fraction (HFNEF) is mainly based on the presence of signs and symptoms.
Central to diagnosis of HF is estimation of intra-cardiac pressure, which can only be obtained from invasive catheterization.
This proposed study aim to:
- Determine intra-LV pressure-time profile non-invasively using recently developed echo Doppler VFM analysis and applanation tonometry and myocardial elastic properties, in HF subjects (both HFNEF and HFREF) compared to normal volunteers.
- Correlate calculated intra-LV pressure parameters with NT ProBNP levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •has presented to hospital with a primary diagnosis of Heart Failure or
- •is attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either:
- •resulted in a hospital admission (primary diagnosis) or
- •was treated in out-patient clinic
- •LVEF >50% is used as cut-off value for HFNEF and LVEF < 50% for HFREF.
- •NT-proBNP within 7 days of admission > 220pg/ml. If there is no result available, NT-proBNP on the same day as echo scan must be > 220pg/ml.
排除标准
- •Haemodynamically significant valve disease defined as more than mild degree of valve stenosis, or more than moderate degrees of mitral or aortic valve regurgitation.
- •History of valvular disease, i.e. rheumatic heart disease and/or having undergone valvular replacement.
- •Isolated right heart failure due to pulmonary disease.
- •Presence of haemodynamically significant obstructive lesions of left ventricular outflow tract.
- •History of any organ transplant or who was on a transplant list (life expectancy < 6 months at time of enrollment).
- •Presence of end-stage renal failure.
- •Pregnancy.
- •The patient is unable to provide written informed consent.
结局指标
主要结局
First occurrence of cardiovascular event
时间窗: 1 Year
次要结局
未报告次要终点
研究者
研究点 (1)
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