Using a new system to manage heart failure in patients

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

This study is testing a new system to help manage heart failure in patients to see if it can improve their health and reduce healthcare costs compared to standard care alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Analog Device, Inc. (Academic / other)
• Locations: 7 sites (Palm Springs, California and 6 other locations)
• Trial ID: NCT05650541 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility and efficacy of the CardioPulmonary Management (CPM) system in patients with chronic heart failure. It aims to determine whether the CPM system can reduce heart failure-related events and healthcare costs while improving quality of care and patient satisfaction. Participants will be randomized into two groups: one receiving the CPM system alongside standard care and a control group receiving standard care only. The study will monitor outcomes over a six-month period, assessing the impact of the CPM system on patient health and healthcare utilization.

Who should consider this trial

Good fit: Ideal candidates include heart failure patients of any ejection fraction, particularly those with NYHA Class II, III, or IV heart failure.

Not a fit: Patients under 18 years old or those with severe COPD or cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of heart failure, reducing hospitalizations and healthcare costs for patients.

How similar studies have performed: Other studies have shown promise in using technology for heart failure management, suggesting potential success for this approach.

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

Where this trial is running

Palm Springs, California and 6 other locations

• Desert Oasis Healthcare — Palm Springs, California, United States (Completed)
• Baptist Health South Florida — Miami, Florida, United States (Recruiting)
• Orlando Health — Orlando, Florida, United States (Recruiting)
• Baystate Medical Center — Springfield, Massachusetts, United States (Active_not_recruiting)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (Active_not_recruiting)
• Cone Health — Greensboro, North Carolina, United States (Completed)
• Prisma Health — Greenville, South Carolina, United States (Completed)

Study contacts

• Study coordinator: Emily Wycallis

Conditions Heart Failure