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 lower health problems and costs while making care better and patients happier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Analog Device, Inc. Academic / other |
| Locations | 1 site (Greensboro, North Carolina) |
| Trial ID | NCT06045117 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and effectiveness of the CardioPulmonary Management (CPM) system in patients with chronic heart failure. It aims to determine if 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 both clinical and financial impacts.
Who should consider this trial
Good fit: Ideal candidates include heart failure patients of any ejection fraction, particularly those with NYHA Class II-IV symptoms or recent hospitalizations.
Not a fit: Patients under 18 years of age or those with severe COPD 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: While this approach is novel, similar studies have shown promise in managing heart failure with technology-based interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Heart failure (HF) patients regardless of ejection fraction, HFpEF (heart failure preserved ejection fraction) or HFrEF (heart failure reserved ejection fraction), with one or more of the 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 Glomerular Filtration 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-type natriuretic peptide) \> 200 pg/ml for patients not in atrial fibrillation (AF) or \> 600 pg/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 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 * 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 as assessed by the investigator * No cellular coverage (Patient's Home)
Where this trial is running
Greensboro, North Carolina
- Cone Health — Greensboro, North Carolina, 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.