Non-Invasive Device to Remotely Monitor Cardiac Function and Reduce Cost of Managing Heart Failure Patients

无创设备可远程监测心脏功能并降低心力衰竭患者的管理成本

• 批准号: 9201410
• 负责人: Daniel Rogers Burnett
• 金额: $ 30.93万
• 依托单位: THERANOVA, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-21 至 2018-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9201410
• 关键词: Acute; Adoption; Adult; Affect; Age-Years; Agreement; Appointments and Schedules; Cardiac; Cardiac health; Cardiology; Cessation of life; Clinic; Clinical; Clinical Research; Devices; Diagnosis; Diagnostic Procedure; Disease; Disease Management; Early Intervention; Elderly; Enrollment; Equipment; Family suidae; Frequencies; Heart failure; Home environment; Hospitalization; Hospitals; Hour; Implant; Individual; Lead; Legal patent; Life; Liquid substance; Lung; Measurement; Measures; Medicare; Methods; Minor; Monitor; Nature; Nebraska; Office Visits; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Prevention; Pulmonary artery structure; Randomized; Reading; Recruitment Activity; Regression Analysis; Resources; Signal Transduction; Stroke Volume; Survival Rate; Symptoms; System; Treatment Cost; United States; Variant; Venous; Weight; acute symptom; base; clinically significant; cost; diaries; hemodynamics; human subject; implanted sensor; improved; in vivo; mortality; multidisciplinary; phase 2 study; pressure; prevent; programs; prototype; research study; respiratory; stem; tool

ABSTRACT Heart failure (HF) is the leading cause of hospitalization among adults over 65 years of age in the United States. In 2014, more than 5.1 million people in the United States were living with a diagnosis of HF, and as many as one in nine deaths each year can be attributed to complications stemming from this disease. The neurohormonal imbalance associated with heart failure leads to fluid retention, resulting in an increase in intracardiac filling pressures, passive elevation of pulmonary venous and arterial pressures, and pulmonary fluid accumulation. Detecting hemodynamic congestion prior to symptom onset allows for early intervention and prevention of hospitalizations. Various parameters have been utilized for patient self-monitoring of cardiac function, including weight tracking, but have shown limited efficacy in reducing hospitalizations. Changes in both pulmonary artery pressure (PAP) and stroke volume (SV) are capable of detecting changes in cardiac function relatively early, but typically require specialized equipment that is not feasible for at-home use. Recent evidence has shown that directly monitoring of PAP via an implantable sensor (CardioMEMS) can provide clinicians with a remote monitoring tool to determine when medication adjustments were needed to prevent decompensation, and reduced 30-day readmissions by 37%. However, the cost (~$25k) and invasive nature of this device severely restricts its clinical adoption rate. TheraNova has developed a non-invasive, handheld respiratory monitor (Cardiospire) that is capable of directly monitoring cardiac function in a remote setting. The device detects minor variations in naturally expired airflow pressure known as cardiogenic oscillations (COS), which correspond with the cardiac cycle. Decreasing SV and increasing PAP both act to diminish the amplitude of COS with worsening HF. In pilot in vivo studies, we have demonstrated that COS is a direct indicator of cardiac function through its direct correlation with SV and inverse proportionality to PAP. The overall objective of this project is to measure COS using the Cardiospire device in stabilized and decompensated HF patients. In Aim 1, we will validate the ability of the device to perform repeatable measurements of COS in HF patients. In Aim 2, we will validate the ability of the device to detect clinically significant changes in cardiac function in HF patients using COS in an observational clinical study. The results of these two aims will provide essential information about device function that we will use during Phase II in a larger clinical study to evaluate Cardiospire as an at-home monitoring system. Ultimately, Cardiospire will allow physicians to remotely monitor their patients’ fluid status and make adjustments to their medications in order to prevent hospitalizations. This type of non-invasive home monitoring could potentially prevent many unnecessary hospitalizations for acute decompensation.

抽象的 心力衰竭 (HF) 是美国 65 岁以上成年人住院的主要原因 国家。 2014 年，美国有超过 510 万人被诊断为心力衰竭，并且 每年有多达九分之一的死亡可归因于这种疾病引起的并发症。这 与心力衰竭相关的神经激素失衡会导致液体潴留，从而导致 心内充盈压、肺静脉压和动脉压被动升高以及肺动脉压 积液。在症状出现前检测血流动力学充血可以进行早期干预 和预防住院治疗。各种参数已用于患者自我监测心脏 功能，包括体重跟踪，但在减少住院治疗方面效果有限。变化 肺动脉压（PAP）和每搏输出量（SV）都能够检测心脏的变化 功能相对较早，但通常需要专门的设备，这对于家庭使用来说不可行。最近的 有证据表明，通过植入式传感器 (CardioMEMS) 直接监测 PAP 可以提供 临床医生使用远程监控工具来确定何时需要调整药物以预防 失代偿，并将 30 天再入院率减少 37%。然而，成本（约 25,000 美元）和侵入性 该设备严重限制了其临床采用率。 TheraNova 开发了一种非侵入式手持式呼吸监测仪 (Cardiospire)，能够直接 远程监测心脏功能。该设备检测自然呼出气流的微小变化 称为心源性振荡 (COS) 的压力，与心动周期相对应。减少SV 和增加 PAP 都会随着 HF 的恶化而降低 COS 的幅度。在体内试验研究中，我们 已经证明 COS 是心脏功能的直接指标，因为它与 SV 和 SV 直接相关 与 PAP 成反比。该项目的总体目标是使用 Cardiospire 测量 COS 稳定和失代偿性心力衰竭患者的装置。在目标 1 中，我们将验证设备的能力 对 HF 患者进行可重复的 COS 测量。在目标 2 中，我们将验证设备的能力 在观察性临床中使用 COS 检测心力衰竭患者心功能的临床显着变化 学习。这两个目标的结果将提供有关我们将使用的设备功能的基本信息 在一项更大规模的临床研究的第二阶段中，该研究评估了 Cardiospire 作为家庭监测系统的效果。最终， Cardiospire 将允许医生远程监控患者的液体状态并调整他们的治疗方案 药物治疗，以防止住院。这种类型的非侵入式家庭监控有可能 避免许多因急性失代偿而不必要的住院治疗。