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Tests treatment safety and results for Heart Failure
Official title Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
ClinicalTrials.gov ID: NCT05650541
What this study is testing
- What it's testing
- The primary purpose for this study is to support the hypothesis (pilot data) that the use of the Sensinel CPM system reduces the rate of HF-related events and the related healthcare cost. The study will also measure the impact on quality of care and patient satisfaction.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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)
See the full eligibility 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...
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Palm Springs, California, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Springfield, Massachusetts, United States
- Omaha, Nebraska, United States
- Greensboro, North Carolina, United States
- Greenville, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palm Springs, California, United States; Miami, Florida, United States; Orlando, Florida, United States; Springfield, Massachusetts, United States; Omaha, Nebraska, United States; Greensboro, North Carolina, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.