Clinical trial NCT05650541: Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
Official title: Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Analog Device, Inc.
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There is a study group that uses the device \& the data is monitored and sent to the physician. The second group is a control group that will not use the device and will continue with normal standard of care.
Primary purpose: PREVENTION

Brief summary: The primary purpose for this study is to support the hypothesis (pilot data) that the use of the CPM system reduces the rate of HF related events and the related healthcare cost. The study will also measure the impact on quality of care and patient satisfaction. In order to support the primary objective, the study will compare the outcomes and costs for patients using the CPM system against those who are not. This can either be done using institutions averages, if available, or through a control group.

Detailed description: This study is meant primarily to determine the clinical and financial efficacy of the CPM system in reducing HF events and their associated cost. Although patients will use an investigational device as part of this pilot, the device is passive and of minimal risk to the patient. No treatment changes will be decided on the CPM data solely. All CPM data will be confirmed with a symptomology assessment and the patient's care provider will make the final determination whether a change of treatment is appropriate or not.

There will be two groups, the study cohort and the control cohort. After informed consent is obtained, the patient will be randomized. The randomization will occur in the EDC and will be 2:1.

The study group will receive all aspects of the CPM monitoring system as a supplement to their normal care routine. They will have one visit at the beginning of the study and one visit 6 months later. Patients in the study group will receive the CPM device at visit 1 and use the CPM device once a day during the monitoring period of the study (6 months) and the data will be monitored by the ADI Care Team. During this period, the research team will monitor the patient's chart, recommended once every 2 weeks, looking for CHF outcomes (i.e. medicine changes, hospitalizations, ER visits, clinic visits). After the 6-month monitoring period, visit 2 will occur. The site research team will continue to monitor the patient's chart for an additional 4 weeks after visit 2 to capture clinical outcomes. Patients using the device will also have the phone number for ADI Tech Support. Patients will be instructed to call this number if they believe their device is malfunctioning or if they have questions on how to use it. Device malfunctions that can be fixed remotely are not classified as adverse events (unless they result in harm). Device malfunctions that require subject to return for an office visit are considered adverse events.

The control group will not receive the CPM monitoring system and will not participates in the visit activities. They will sign the consent form and go through the screening process as usual. Their chart will be monitored for 7 months, recommended once every 2 weeks, to have their outcomes captured. At the beginning of the study, they will receive a phone call to confirm their medications and past medical history (as detailed in the medical history section below). They will receive a call after 6 months to terminate the study, followed by an additional one month of monitoring.

Eligibility criteria: Inclusion Criteria:

Heart failure patients regardless of ejection fraction (HFpEF or HFrEF) with one or more of the following:

* NYHA Class III HF
* NYHA Class IV HF

OR

* NYHA Class II HF with one or more of the following:
* Chronic Kidney Disease (eGFR\<60 within the past 6 months)
* 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/ml\* 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)

Exclusion Criteria:

* Under 18 years of age

  * Patients with severe COPD (GOLD stage III or IV)
  * Limited mobility preventing application of device or no caregiver to assist
  * Cognitive impairments that would limit the application and proper use of the device
  * Skin allergies or skin sensitivities to silicone-based adhesives
  * Pregnancy (method of assessment at the discretion of the PI)
  * Not willing to shave chest hair if needed to apply device
  * Patients on chronic IV ionotropic therapy - (Milrinone, Dobutamine, and Dopamine)
  * 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)\*\*
  * Skin breakdown on the left chest or breast area

Primary outcomes:
measure: Admission Rate
timeFrame: 7 months
measure: Readmission Rate
timeFrame: 7 months
measure: Healthcare Utilization
timeFrame: 7 months
measure: Patient satisfaction
timeFrame: 6 months
measure: Cost of care
timeFrame: 7 months (during study) and 12 months prior to the study
measure: Quality of care
timeFrame: 6 months
Secondary outcomes:
measure: Usability
timeFrame: 6 months
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare
state: California
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Greensboro
country: United States
facility: Cone Health
state: North Carolina
Study officials:
References: