Heart Failure Clinical Trial
Official title:
Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
The primary purpose for this study is to support the hypothesis (pilot data) that the use of the CardioPumonary Management (CPM) system reduces the rate of heart failure (HF) related events and the related healthcare cost. The study will also measure the impact on quality of care and patient satisfaction. In order to support the primary objective, the study will compare the outcomes and costs for patients using the CPM system against those who are not. This can either be done using institutions averages, if available, or through a control group.
Status | Not yet recruiting |
Enrollment | 75 |
Est. completion date | July 1, 2026 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Baptist Health South Florida | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Analog Device, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Admission Rate | Admission rate for Heart Failure (HF) and HF related events in the study group vs. the institution's averages (and/or control group) | 7 months | |
Primary | Readmission Rate | Readmission rate for Heart Failure (HF) and HF related events in study group vs. the institution's average (and/or control group) | 7 months | |
Primary | Healthcare utilization | Healthcare utilization for Heart Failure (HF) related events, including number of practice visits, emergency room (ER) visits, outpatient visits, skilled nursing facility (SNF) days and Hospital Admissions | 7 months | |
Primary | Patient satisfaction | Patient satisfaction obtained through survey questions; ease of use, impact and satisfaction; scale of 1-7 used with 1 being negative and 7 being positive. | 6 months | |
Primary | Cost of Care | Total cost per capita for Heart Failure (HF) related care | Time Frame: 7 months (during study) and 12 months prior to the study | |
Primary | Quality of Care | Impact on quality of care using Consumer Assessment of Healthcare Providers and Systems survey. | 6 months | |
Secondary | Usability | Usability data obtained through questionnaires given to the healthcare providers assessing the usability of the CardioPulomary Management (CPM) system; scale of 1-7 used with 1 being negative and 7 being positive. | 6 months |
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