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

Last updated: February 22, 2024
Sponsor: Analog Device, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Hyponatremia

Treatment

CardioPumlonary Management System (CPM)

Clinical Study ID

NCT06045117
BETA-CONE
  • Ages > 18
  • All Genders

Study Summary

The primary purpose for this study is to support the hypothesis (pilot data) that the use of the CardioPumonary Management (CPM) system reduces the rate of heart failure (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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Heart failure (HF) patients regardless of ejection fraction, HFpEF (heart failure preservedejection fraction) or HFrEF (heart failure reserved ejection fraction), with one or more ofthe following:

  • New York Heart Association (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) (Estimated GlomerularFiltration Rate)
  • HF hospitalization (defined as HF listed as the major reason for hospitalization)within 9 months prior to screening visit and NT-proBNP (N-terminal pro b-typenatriuretic peptide) > 200 pg/ml for patients not in atrial fibrillation (AF) or > 600pg/m for patients in AF on screening ECG (electrocardiogram)
  • NT-proBNP > 300 pg/ml for patients not in AF or > 900 pg/ml for patients in AF on thescreening visit ECG.
  • Chronic obstructive pulmonary disease (COPD)

Exclusion

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 asassessed by the investigator
  • No cellular coverage (Patient's Home)

Study Design

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: CardioPumlonary Management System (CPM)
Phase:
Study Start date:
September 22, 2023
Estimated Completion Date:
October 01, 2026

Study Description

This study is meant primarily to determine the clinical and financial efficacy of the CardioPulmonary Management (CPM) system in reducing heart failure (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 Electronic Data Capture system (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 (Analog Devices, Inc.) Care Team. During this period, the research team will monitor the patient's chart, recommended once every 2 weeks, looking for Chronic Heart Failure (CHF) outcomes (i.e. medicine changes, hospitalizations, Emergency Room 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.

Connect with a study center

  • Cone Health

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.