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Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit, 4 visits
  • Time periods mentioned: 7 months
  • Procedures mentioned: Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "They will have one visit at the beginning of the study and one visit 6 months later."
  • "The site research team will continue to monitor the patient's chart for an additional 4 weeks after visit 2 to capture clinical outcomes."
  • "Their chart will be monitored for 7 months, recommended once every 2 weeks, to have their outcomes captured."
  • "At the beginning of the study, they will receive a phone call to confirm their medications and past medical history (as detailed in the medical history section below)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the Sensinel CPM system lowers heart failure events and care costs in people with long-term heart failure. It compares people using the system with people not using it or with hospital averages. It also looks at quality of care and how patients feel about their care.

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. In order to support the primary objective, the study will compare the outcomes and costs for patients using the Sensinel CPM system against those who are not. This can either be done using institutions' averages, if available, or through a control group.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You may qualify no matter how much blood your heart pumps with each beat.
  • You must have heart failure in NYHA class III or IV (symptoms with little activity or at rest), OR class II (symptoms with normal activity) plus at least one condition listed below.
  • For class II: long-term kidney disease, with an eGFR below 60 in the past 6 months. This test measures how well your kidneys filter blood.
  • For class II: a hospital stay mainly for heart failure in the past 9 months, plus an NT-proBNP blood level above 200 pg/ml, or above 600 pg/ml if you have AF on your screening heart tracing. NT-proBNP measures heart strain. AF is an irregular heartbeat.
  • For class II: an NT-proBNP level above 300 pg/ml, or above 900 pg/ml if you have AF on your screening heart tracing.
  • For class II: COPD, a long-term lung disease that makes breathing hard.

Who can't join

  • You are under 18 or pregnant.
  • You have severe COPD (GOLD stage III or IV).
  • Trouble moving keeps you from putting on the device, you have no caregiver to help, or thinking or memory problems limit proper device use.
  • You have a skin allergy or sensitivity to silicone-based sticky materials, or damaged skin on your left chest or breast.
  • You are not willing to shave chest hair if needed to attach the device.
  • You receive ongoing medicine through a vein to help your heart pump, such as milrinone, dobutamine, or dopamine.
  • The study doctor thinks a health condition may limit your life to less than 1 year.
  • You have no cell phone signal at home.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 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) * 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

Study sites (7)

CA

FL

MA

NC

NE

SC