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

NCT ID: NCT05650541

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-22
• Study Completion Date: 2026-06-01

Brief Summary

The primary purpose for this study is to support the hypothesis (pilot data) that the use of the Sensinel 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 Sensinel 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Study Group

The study group will use the CPM device daily for 6 months (beginning at visit 1 and ending at visit 2). The ADI triaging team will monitor the CPM device data and call the patient as indicated by the data. The ADI care team will then forward the device data and patient symptomology collected to the patient's care team where that team will device if intervention is necessary. The patient's care team will also have access to view device data at any time using the CPM website.

Group Type: EXPERIMENTAL

CardioPumlonary Management System

Intervention Type: DEVICE

The CPM Device measures and trends a variety of physiologic parameters including thoracic impedance, respiration rate, tidal volume, ECG, heart rate, and diastolic heart sounds, all in an unobtrusive patch form factor.

Control Group

The control group will not receive a device and will continue their normal standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CardioPumlonary Management System

The CPM Device measures and trends a variety of physiologic parameters including thoracic impedance, respiration rate, tidal volume, ECG, heart rate, and diastolic heart sounds, all in an unobtrusive patch form factor.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Analog Device, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Desert Oasis Healthcare

Palm Springs, California, United States

Site Status: COMPLETED

Baptist Health South Florida

Miami, Florida, United States

Site Status: RECRUITING

Orlando Health

Orlando, Florida, United States

Site Status: RECRUITING

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status: ACTIVE_NOT_RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status: ACTIVE_NOT_RECRUITING

Cone Health

Greensboro, North Carolina, United States

Site Status: COMPLETED

Prisma Health

Greenville, South Carolina, United States

Site Status: COMPLETED

Countries

United States

Central Contacts

Emily Wycallis

Role: CONTACT

emily.wycallis@analog.com

978-435-1644

Facility Contacts

Anabel Elizechea Gispert, RN, BSN, MSN

Role: primary

anabel.elizacheagispert@baptisthealth.net

786-595-8073

Caitlin Cox, RN, BSN

Role: primary

caitlin.cox@orlandohealth.com

321-841-1505

Other Identifiers

BETA-3.0

Identifier Type: -

Identifier Source: org_study_id