Assessing a home monitoring system for heart failure patients
Clinical Data Collection Study Using CardioPulmonary Management System in Patients With Chronic Heart Failure
This study is testing a home monitoring system for heart failure patients to see how it works with their current care and if it can help prevent hospital visits in the future.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Analog Device, Inc. Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06007079 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of the ADI CPM System in a home environment for heart failure patients, focusing on its interoperability with existing care pathways. Clinicians will not use the data generated by the CPM system for immediate clinical decisions, but a retrospective review will analyze the data against treatment changes and heart failure events. Participants will engage with the CPM device daily for five months, followed by an additional month of observation for heart failure-related events. The findings will inform the design of a future interventional study aimed at preventing heart failure hospitalizations.
Who should consider this trial
Good fit: Ideal candidates include heart failure patients of any ejection fraction with specific clinical criteria such as NYHA Class II-IV and certain biomarkers.
Not a fit: Patients with severe COPD, significant cognitive impairments, or severe chronic kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance home monitoring for heart failure patients, potentially reducing hospitalizations.
How similar studies have performed: While similar approaches have been explored, this specific use of the CPM system in a home setting is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
New York, New York
- Columbia University Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Emily Wycallis
- Email: emily.wycallis@analog.com
- Phone: 9784351644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.