Clinical Data Collection Study Using CardioPulmonary Management System in Patients With Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Record number of heart failure events
研究概览
简要总结
This study will assess the deployment of the ADI CPM System in a home setting and determine the interoperability of the CPM System within existing care pathways for HF patients. Clinicians will be blinded to CPM generated data and acquired physiologic data will not be used in clinical decision-making. After conclusion of this phase, a retrospective review of CPM System-acquired data will be compared with changes in treatment and HF events. This retrospective review will inform the subsequent design of the interventional study that is planned. Study participation for each patient will last for six months inclusive of 5 months of daily CPM monitoring followed by 30 days of observation for HF-related events. The additional 30 days of medical record observation is intended to capture any events that might correspond to predictions made during the final weeks of CPM monitoring.
详细描述
The current investigation is designed to be an observational study of the feasibility of using the CPM system. Its goal is to familiarize the study team with the CPM system, uncover potential challenges in its deployment, assess its predictive ability, and ultimately define clinical protocols to react to CPM generated information. The next phase of investigation will be a pilot study of the efficacy of using the CPM system to prevent heart failure hospitalizations.
The patient will use the CPM device once daily during the first 5 months of the study. Patient records will be retrospectively reviewed over those 5 months plus an additional 30 days following the final CPM measurement to assess for any CHF-related events.
Baseline/Initial Visit (Visit 1):
At this visit, the start of the study, the information described in the "Baseline Assessments" section will be collected. The study will be re-described to the participant. The study team will then set up the device for the individual patient by making adjustments (as needed) to address patient specific anatomy, ensuring that the sensors are all contacting the appropriate chest areas, and confirming the measurements on the CPM Web application. The patient will be shown how to apply and replace the adhesive on the device, how to position the device, how to take a measurement with the device, and how to store the device on the Base Station. The trained provider will then register the baseline reading for the CPM device using the CPM Mobile App. Informational material about using the device, refreshing adhesives, and interpreting device LEDs and chimes will be provided to each patient. Each patient will be reminded to take a measurement with their CPM at the same time each day (preferably when they first wake up) and instructed to follow the medical regimen prescribed by their physician.
Between Visits:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Heart failure patients regardless of ejection fraction (HFpEF or HFrEF) with one or more of the following:
- •NYHA Class III-IV
- •NYHA Class II HF with one or more of the following:
- •Chronic Kidney Disease (eGFR<60)
- •HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP > 200 pg/ml for patients not in AF or > 600 pg/m for patients in AF on screening ECG
- •NT-proBNP > 300 pg/ml for patients not in AF or > 900 pg/ml for patients in AF on the screening visit ECG.
- •Chronic obstructive pulmonary disease (COPD)
排除标准
- •Under 18 years of age
- •Patients with severe COPD (GOLD stage III or IV)
- •Chronic Kidney Disease (eGFR < 20)
- •Limited mobility preventing application of device
- •Cognitive impairments that would limit the application and proper use of the device
- •Skin allergies or skin sensitivities to silicone-based adhesives
- •Pregnancy
- •Skin breakdown on the left chest or breast area
- •Not willing to shave chest hair if needed to apply device
- •Patients on chronic inotropic therapy
- •Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator
- •No cellular coverage (Patient's Home)
研究组 & 干预措施
Device Use
Patients will be given the CPM device to take home and use once daily
干预措施: CPM Device (Device)
结局指标
主要结局
Record number of heart failure events
时间窗: 5 months
A HF hospitalization is defined as any unplanned visit to a hospital, Emergency Department or Observation unit with a length of stay of at least 24 hours AND treatment with intravenous diuretics. Worsening heart failure is defined as having at least one sign or symptom of congestion including but not limited to: worsening dyspnea, orthopnea, PND, JVD, S3 gallop, pulmonary crackles, ascites or edema. Urgent treatment is defined as any use of intravenous diuretic therapy or an increased diuretic dosage (at least 2x baseline dose) and/or additional class of diuretics.
Sensitivity
时间窗: 6 months
Measuring the sensitivity of each parameter with respect to the ability to predict a CHF event. Sensitivity is defined as TP/(TP+FN) = True Positive/(True Positive+False Negative)
Specificity
时间窗: 6 months
Measuring the specificity of each parameter with respect to the ability to predict a CHF event. Specificity is defined as TN/(TN+FP) = True Negative/(True Negative+False Positive)
次要结局
- Patient compliance(5 months)
- Data quality(5 months)