Clinical trial NCT06007079: Clinical Data Collection Study Using CPM System
Official title: Clinical Data Collection Study Using CardioPulmonary Management System in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Analog Device, Inc.
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2023-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will assess the deployment of the ADI CPM System in a home setting and determine the interoperability of the CPM System within existing care pathways for HF patients. Clinicians will be blinded to CPM generated data and acquired physiologic data will not be used in clinical decision-making. After conclusion of this phase, a retrospective review of CPM System-acquired data will be compared with changes in treatment and HF events. This retrospective review will inform the subsequent design of the interventional study that is planned. Study participation for each patient will last for six months inclusive of 5 months of daily CPM monitoring followed by 30 days of observation for HF-related events. The additional 30 days of medical record observation is intended to capture any events that might correspond to predictions made during the final weeks of CPM monitoring.

Detailed description: The current investigation is designed to be an observational study of the feasibility of using the CPM system. Its goal is to familiarize the study team with the CPM system, uncover potential challenges in its deployment, assess its predictive ability, and ultimately define clinical protocols to react to CPM generated information. The next phase of investigation will be a pilot study of the efficacy of using the CPM system to prevent heart failure hospitalizations.

The patient will use the CPM device once daily during the first 5 months of the study. Patient records will be retrospectively reviewed over those 5 months plus an additional 30 days following the final CPM measurement to assess for any CHF-related events.

Baseline/Initial Visit (Visit 1):

At this visit, the start of the study, the information described in the "Baseline Assessments" section will be collected. The study will be re-described to the participant. The study team will then set up the device for the individual patient by making adjustments (as needed) to address patient specific anatomy, ensuring that the sensors are all contacting the appropriate chest areas, and confirming the measurements on the CPM Web application. The patient will be shown how to apply and replace the adhesive on the device, how to position the device, how to take a measurement with the device, and how to store the device on the Base Station. The trained provider will then register the baseline reading for the CPM device using the CPM Mobile App. Informational material about using the device, refreshing adhesives, and interpreting device LEDs and chimes will be provided to each patient. Each patient will be reminded to take a measurement with their CPM at the same time each day (preferably when they first wake up) and instructed to follow the medical regimen prescribed by their physician.

Between Visits:

Between visits, caregivers will not have any access to the data being collected on the CPM System. They should perform their usual standard of care on these patients. Participants will receive one call from the study team after 1 week of monitoring to check in about the progress of the study (i.e. if protocols are being followed correctly, if the CPM device is working properly, and if adherence is satisfactory). If the participant is found to have problems with the device, a follow up at week 2 can be scheduled. The check-in conversation topics should focus on any ease of use issues and address any technical barriers impacting compliance.

Follow-up Visit (Visit 2):

On this visit, which will take place at the end of the 5 months, the study team will make arrangements for the patient to return to the office for a check-up and return the device (the same tests as described in the "physical examination" section). Patients will also be asked about their perception on "ease of use", impact on day to day activities, and overall satisfaction with the CPM system. Thirty days following the last measurement the study team, will review the patients records for all HF related events and treatment changes. Study protocol will also include a phone call to the patient to inquire if they had any heart failure events during this time.

Post-Monitoring (Data review):

After the completion of the monitoring, the study team will analyze the de-identified data from the CPM system and correlate it with clinical events obtained from patients and their medical records. Threshold events flagged in the CPM data will then be compared to clinical data to determine the CPM's performance characteristics (sensitivity, specificity, PPV, NPV and AUC ROC), and median prediction time for HF events.

Eligibility criteria: 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)
  * 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)
* Chronic Kidney Disease (eGFR \< 20)
* 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 inotropic 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)

Primary outcomes:
measure: Record number of heart failure events
timeFrame: 5 months
measure: Sensitivity
timeFrame: 6 months
measure: Specificity
timeFrame: 6 months
Secondary outcomes:
measure: Patient compliance
timeFrame: 5 months
measure: Data quality
timeFrame: 5 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
References: