NON-INVASIVE WRIST-WATCH DEVICE FOR REMOTE MONITORING OF HEART FAILURE PATIENTS

用于远程监测心力衰竭患者的非侵入式腕表设备

• 批准号: 10249748
• 负责人: Maria Merchant
• 金额: $ 22.47万
• 依托单位: INCARDIA INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10249748
• 关键词: Acute; Adult; Affect; Agreement; American; Cardiac; Cardiac Catheterization Procedures; Catheters; Chronic; Clinical; Clinical Research; Clinical Trials; Congestive; Data Analyses; Detection; Devices; Diagnosis; Diagnostic; Effectiveness; Goals; Gold; Health Care Costs; Health Expenditures; Health Professional; Healthcare; Heart; Heart Atrium; Heart failure; Home; Hospitalization; Hospitals; Lead; Left; Measures; Methods; Monitor; Morbidity - disease rate; Myocardium; Patients; Pharmaceutical Preparations; Phase; Physicians; Pilot Projects; Preparation; Prevention; Quality of life; Reporting; Research Project Grants; Resources; Small Business Innovation Research Grant; Symptoms; Technology; Testing; TimeLine; Venous; Visit; Work; Wrist; clinical practice; cost; design; experience; health care service; health care service utilization; hemodynamics; hospital readmission; improved; innovation; light weight; monitoring device; mortality; pressure; prevent; prototype; readmission rates; recruit; remote monitoring; research clinical testing; research study

ABSTRACT The objective of this study is to prove the feasibility of an innovative diagnostic device for the detection and monitoring of worsening heart failure. Heart failure affects 6.5 million of Americans and cost the US over $30B a year in healthcare services, medications and missed work. These costs are expected to double by 2030. Heart failure is associated with high healthcare utilization due to frequent hospital re-admissions. Heart failure is the most common diagnosis in all hospital admissions in patients over 65. The readmission rate is high – over 20% by 30 days, and 30% by 90 days post-discharge. There is a significant need for in-home non-invasive methods to detect early stages of destabilization in heart failure. Hemodynamic congestion defined as increasing filling pressures in the heart typically precedes other clinical symptoms. Detection and monitoring of hemodynamic congestion offers the healthcare professionals an opportunity to intervene by adjusting the medications and to prevent acute heart failure episodes and hospitalizations. This pilot clinical research study is designed to demonstrate that the innovative CorWatch™ technology is effective in detecting hemodynamic congestion in heart failure. CorWatch™ detects increases in central venous and right atrial pressures which are concordant with increase in the left heart filling pressures. Adult heart failure patients undergoing cardiac catheterization in a cardiac lab will be recruited for this study. The specific aims are to further develop CorWatch™ devices for the clinical trial; and to demonstrate a good agreement between the CorWatch™ technology and the cardiac pressures measured with the gold standard – Swan Ganz catheter. If this research study shows the effectiveness of the proposed diagnostic approach, CorWatch™ device can potentially be integrated into clinical practice of cardiologists and other physicians as an easy-to-use in-home non-invasive device for monitoring of heart failure. CorWatch™ will offer early warnings of worsening heart failure and aid healthcare professionals in prevention of patient’s destabilization that can lead to acute heart failure episode and hospitalization. Therefore, CorWatch™ has a potential to reduce the healthcare costs and to improve quality of life of heart failure patients.

抽象的 本研究的目的是证明用于检测和诊断的创新诊断设备的可行性 监测恶化的心力衰竭。心力衰竭影响 650 万美国人，给美国造成的损失超过 $30B 一年的医疗保健服务、药物和缺勤。到 2030 年，这些成本预计将增加一倍。 由于频繁再次入院，心力衰竭与医疗保健的高利用率相关。心脏衰竭 是所有入院 65 岁以上患者中最常见的诊断。再入院率很高 – 超过 出院后 30 天为 20%，90 天为 30%。对家用非侵入式设备的需求非常大 检测心力衰竭早期不稳定的方法。血流动力学充血定义为 心脏充盈压增加通常先于其他临床症状出现。检测和监测 血流动力学充血为医疗保健专业人员提供了通过调整血流动力学干预的机会 药物治疗并预防急性心力衰竭发作和住院。 该试点临床研究旨在证明创新的 CorWatch™ 技术 有效检测心力衰竭的血流动力学充血。 CorWatch™ 检测中心静脉的增加 右心房压力与左心充盈压的增加一致。成人心力衰竭 本研究将招募在心脏实验室接受心导管插入术的患者。具体目标是 进一步开发用于临床试验的 CorWatch™ 设备；并证明双方之间达成了良好的协议 CorWatch™ 技术和使用黄金标准 – Swan Ganz 导管测量的心脏压力。如果 这项研究表明了所提出的诊断方法的有效性，CorWatch™ 设备可以 有可能作为一种易于使用的家用设备融入心脏病专家和其他医生的临床实践中 用于监测心力衰竭的非侵入性设备。 CorWatch™ 将提供心脏恶化的早期预警 失败并帮助医疗保健专业人员预防可能导致急性心脏病的患者不稳定 失败事件和住院治疗。因此，CorWatch™ 有潜力降低医疗保健成本和 改善心力衰竭患者的生活质量。