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Study of the CardioPulmonary Management (CPM) System for Heart Failure

This study is testing a device called the CardioPulmonary Management (CPM) System in people with heart failure. The CPM System is a small patch that measures things like your breathing, heart rate, and heart sounds. The goal is to see if using this system can reduce heart failure-related events (like hospitalizations) and healthcare costs, as well as improve your quality of care and satisfaction. You might be able to join if you are 18 or older and have heart failure, especially if it's NYHA Class III or IV, or Class II with kidney disease or a recent heart failure hospitalization. The study will compare outcomes for those using the CPM system versus those who are not. The study is currently recruiting 1200 participants.

Study design
This is an interventional study with two groups: a study group using the CPM system and a control group. You would be randomly assigned to one of these groups, with two people in the study group for every one person in the control group.
What's involved
If you are in the study group, you will have two visits over 6 months. You will receive the CPM device at the first visit and use it once a day for 6 months.
Compensation
Not stated in the trial record.
Follow-up
Your admission rate, readmission rate, and healthcare utilization will be measured at 7 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05650541

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

Recruiting
NAAges 18+InterventionalPrevention
Analog Device, Inc.
~1,200 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:CardioPumlonary Management System

At a glance

Recruiting sites
2 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Admission Rate
Measured over 7 months
+5 more outcomes measured

Conditions

Heart Failure

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Heart Failure

NCT05650541

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baptist Health South Florida

    Miami, Floridastudy coordinator listed

    Recruiting

  • Orlando Health

    Orlando, Floridastudy coordinator listed

    Recruiting

  • Baystate Medical Center

    Springfield, Massachusettsno site contact published

    Completed

  • Cone Health

    Greensboro, North Carolinano site contact published

    Completed

  • Desert Oasis Healthcare

    Palm Springs, Californiano site contact published

    Completed

  • Prisma Health

    Greenville, South Carolinano site contact published

    Completed

  • University of Nebraska Medical Center

    Omaha, Nebraskano site contact published

    Completed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Emily Wycallis
[email protected]
978-435-1644
Email the study team

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Eligibility criteria

Inclusion

NYHA Class III HF
NYHA Class IV HF
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

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

What this trial measures

  • Admission Rate7 months

    Admission rate for HF and HF related events in the study group vs. the institution's averages (and/or control group)

  • Readmission Rate7 months

    Readmission rate for HF and HF related events in study group vs. the institution's average (and/or control group)

  • Healthcare Utilization7 months

    Healthcare utilization for HF related events, including number of practice visits, ER visits, outpatient visits, skilled nursing facility (SNF) days and Hospital Admissions

  • Patient satisfaction6 months

    Patient satisfaction obtained through surveys

  • Cost of care7 months (during study) and 12 months prior to the study

    Total cost per capita for HF related care

  • Quality of care6 months

    Impact on quality of care