Feasibility and Efficacy Study of the CardioPulmonary Monitoring (CPM) System in Patients With Chronic Heart Failure

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 & have their data reviewed by a physician against those who are using the CPM system and not having their data reviewed.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: CPM Device + Monitoring; Drug: CPM Device

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 receive the CPM device, but its data will not be monitored. They will sign the consent form and go through the screening process as usual. They will participate in the same visits as the study group and use the device once daily, ideally in the morning (same as study group0. Their chart will also be monitored during the 6 month of device use and for 30 days after. They will not receive calls about their device data.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Emily Wycallis; Phone Number: 9784351644; Email: emily.wycallis@analog.com

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health
      • Contact: Rebecca Rebain; Phone Number: 864-455-7793; Email: Rebecca.Rebain@PrismaHealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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 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/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)

Exclusion Criteria:

• Under 18 years of age
• Patients with severe COPD (GOLD stage III or IV)
• 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 ionotropic 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; The study group will use the device one time daily (in the morning). The data will be reviewed and sent to the provider as detailed by the protocol.	Device: CPM Device + Monitoring; Daily device use & data monitoring leading to symptomology assessment and notification to provider.
Sham Comparator: Control Group; The control group will use the device one time daily (in the morning). The data will not be reviewed or acted upon.	Drug: CPM Device; Daily device use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Admission rate	admission rate for HF and HF related events between arms	7 months (during study) and 12 months prior to the study
Readmission rate	readmission rate for HF and HF related events between arms	7 months (during study) and 12 months prior to the study
Healthcare Utilization	Healthcare utilization for HF related events, including number of practice visits, ER visits, outpatient visits, skilled nursing facility (SNF) days and Hospital admissions between arms nursing facility (SNF) days and Hospital Admissions	7 months (during study) and 12 months prior to the study
Cost of care	total cost per capita for HF related care	7 months (during study) and 12 months prior to the study
Quality of care	Impact on quality of care using Consumer Assessment of Healthcare Providers and Systems survey	6 months
Patient satisfaction	patient satisfaction obtained through survey questions; ease of use, impact and satisfaction; scale of 1-7 used with 1 being negative and 7 being positive	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Usability data obtained through questionnaires given to the healthcare providers assessing the usability of the CPM system	6 months

Collaborators and Investigators

• Sponsor: Analog Device, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): June 13, 2024
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: BETA-PRISMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes