Non-invasive Filling Pressure(NIFP) Device Based on Low Frequency Heart Sound in Assessment of Congestion in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Noninvasive filling pressure testing has clinical significance consistent with NT-proBNP and CCS scores to reflect congestion in acute heart failure.
研究概览
简要总结
Congestion plays a key role in heart failure (HF) trajectory .Clinical congestion refers to the signs and symptoms resulting from elevated cardiac filling pressures. Hemodynamic congestion refers to elevated cardiac filling pressures, which may occur days or weeks before the presentation of symptoms , , .
Serial assessment of congestion is required in each encounter of the HF patients, while in current clinical practice, serial assessment of congestion relies on physical examination, sometimes supported by BNP test. Both physical and BNP test are reported to be unreliable in some cases ， . Echocardiography is good tool, but it requires skilled physician to operation and is more time consuming. In general, there is unmet needs of better tools for serial assessment of congestion in HF patient management.
In this study, we aim to prospectively observe and evaluate the feasibility of using a novel non-invasive device in assessment of congestion in HF patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute heart failure；Stabilized outpatient chronic heart failure patients；Willing to sign the inform consent
排除标准
- •1.Patients under 18 years old 2.Patients with congenital heart diseases (e.g., tetralogy of Fallot, atrial septal defect, Fontan disease, single chamber disease) 3.Patients with implanted artificial mechanical valves, pacemaker or ICD. 4.Patients with significant back issues that prevent them from lying supine on the bed 5.Pregnant patients 6.Patient wight under 35 kg or over 150 kg 7.Patients who are attaching to other medical device that prevent them to receive a test by the study device.
结局指标
主要结局
Noninvasive filling pressure testing has clinical significance consistent with NT-proBNP and CCS scores to reflect congestion in acute heart failure.
时间窗: 2025-7-1
Noninvasive filling pressure testing has clinical significance consistent with NT-proBNP and CCS scores to reflect congestion in acute heart failure.
次要结局
未报告次要终点