Characterizing Noninvasive Cardiovascular Measures Collected Passively and In Response to an Isometric Handgrip Stress Test From CVInsight®, Connex ProBP, and Zio® XT Patch in Patients With Acute Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Evidence of correlation between CVInsight signals and Pulmonary Capillary Wedge Pressure or Pulmonary Artery Pressure
研究概览
简要总结
HF001 is a prospective observational study utilizing non-invasive medical devices that may be able to discriminate changes in heart failure while acutely decompensated patients undergo routine interventional therapies in a hospital setting. Subjects will be monitored using CVInsight™ [CVI] via a finger and/or forehead sensor, while performing an isometric handgrip stress test (IHGST). Changes in the CVI signal will be analyzed and correlated to standard assessments of heart failure including pulmonary artery catheter (PAC) pressures, blood pressure (BP), patient symptoms, and physical exam findings. The results of this study will be used to develop a powered study to determine if a new configuration of non-invasive monitoring devices can be used to monitor heart failure status more sensitively than current non-invasive techniques.
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
- •Adult patients ≥ 18 years old
- •Signs and symptoms of congestive heart failure including two of the following:
- •Peripheral edema (e.g. abdominal distension, hepatomegaly, lower extremity edema) in the setting of elevated jugular venous pressure as assessed by the clinical examination, or by right heart catheterization.
- •Pulmonary edema or pleural effusion as seen on chest X-ray
- •Elevated N-terminal pro-brain natriuretic peptide (NT-Pro BNP) 2x the upper limit of normal.
- •Willing and able to comply with the study protocol
- •Willing and able to give valid Informed Consent
排除标准
- •Pregnant patients
- •Presence of Left Ventricular Assist Device (LVAD) or heart transplant
- •Complex congenital heart disorder or prosthetic valve on right side
- •Known mitral stenosis
- •Unstable medical condition or impairment other than condition associated with HF
- •Unstable hypertension
- •Too unstable in the judgment of the investigator to be included in the study
- •Active lung infection or acute pulmonary decompensation
- •Elevated white blood cell count and signs of infection are evident
- •Does not have the cognitive ability to understand and sign the Informed Consent
- •Does not have the cognitive capacity to perform handgrip test
- •Is not able to perform a handgrip stress test
- •Is not able to wear any of the devices
- •Patient's life expectancy is less than 3 months
结局指标
主要结局
Evidence of correlation between CVInsight signals and Pulmonary Capillary Wedge Pressure or Pulmonary Artery Pressure
时间窗: Upon completion of catheter assessments for all enrolled subjects, approximately 6 months from study activation
次要结局
未报告次要终点