Study for the Evaluation of a Non-invasive Hemodynamic Measurement in Heart Failure Patients

Study Overview
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Brief Summary
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Track changes in non-invasive central venous pressure across hospital stay and relationship with readmission

Detailed Description
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Determining the degree of congestion is important in deciding appropriate timing for discharging hospitalized heart failure patients. Central venous pressure (CVP) reflects the returning blood volume to the heart and can guide therapy to relieve congestion. However, the conventional method used to measure CVP has notable limitations as it is an invasive procedure that requires placement of a central venous catheter. Traditional, non-invasive methods of estimating CVP, such as physical examination and echocardiogram, are less accurate and more resource intensive. To overcome this challenge, new technology to assess CVP non-invasively using an oscillometric method has been developed. This new technology involves measurement of the enclosed zone central venous pressure (ezCVP), which, in a preclinical study, has been shown to correlate with invasive data. Additionally, a previous correlation study demonstrated that the ezCVP value can be mathematically adjusted to estimate invasive CVP. The resulting value has been termed CVPNI (CVP Non-Invasive). Most recently, a limited pilot study of patients hospitalized with acute, decompensated heart failure demonstrated the feasibility of device use in this population and the expected and incremental fall in CVPNI with medical treatment over the course of hospitalization. Moving forward, and in order to further improve the care of patients hospitalized with heart failure, an expanded pilot study of ezCVP technology is needed to prove that changes in CVPNI track with these patients' condition during admission and can be useful in their clinical care.

Official Title
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Pilot Study for the Evaluation of ezCVP in Heart Failure Patients

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: ezCVP measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Arm circumference of 23 cm to 55 cm Subject admitted to the hospital with acute exacerbation of heart failure, with either reduced or preserved ejection fraction Subject is at risk for readmission (NYHA Functional Classification 2-3) Subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written, informed consent ezCVP indicator is high (CVPNI is over 9 mmHg) at admission Subject is willing and able to comply with protocol procedures Subject tested negative for COVID test after admission to the hospital Exclusion Criteria: Finger and upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff Pregnant (self-reported) Upper extremity DVT (currently being treated) Severe skin disease involving the upper arm(s) Study investigator may exclude patients based on clinical judgement

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult CHF subjects with initial high CVP<br>Adult subjects with congestive heart failure diagnosis who have an indicated high non-invasive estimated central venous pressure on first measurement after clinical unit admission. | Device: ezCVP measurement<br>* Measuring device: non-FDA-cleared patient monitor (740E, Zoe Medical, MA, US), which has software to measure ezCVP. Sensor: an FDA-cleared pulse oximeter sensor for adults (K012891: DS-100A, Nellcor, CA, US). Cuff: an FDA-cleared NIBP cuff for adults (K080342: YP-713T, YP-714T or TP-715T, Nihon Kohden Corporation, Tokyo, Japan).<br>|
| Adult CHF subjects with initial low CVP<br>Adult subjects with congestive heart failure diagnosis who have an indicated low non-invasive estimated central venous pressure on first measurement after clinical unit admission. | Device: ezCVP measurement<br>* Measuring device: non-FDA-cleared patient monitor (740E, Zoe Medical, MA, US), which has software to measure ezCVP. Sensor: an FDA-cleared pulse oximeter sensor for adults (K012891: DS-100A, Nellcor, CA, US). Cuff: an FDA-cleared NIBP cuff for adults (K080342: YP-713T, YP-714T or TP-715T, Nihon Kohden Corporation, Tokyo, Japan).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the difference between non-invasive CVP measurement at admission and at discharge | Compare CVPNI at time of admission and discharge in clinical unit CVPNI (CVP subscript NI) is a numeric value equivalence of central venous pressure non-invasive measured in mmHg. | 7 days | 
| Evaluate the difference between non-invasive CVP measurement in right and left arms | Compare CVPNI (mmHg) for measurements on left and right arm for same subject | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the relationship between CVPNI at discharge and readmission rate | Compare CVPNI (mmHg) at time of discharge for high ezCVP subjects to subsequent readmission occurrence within 90-100 days post hospital discharge | 100 days | 
| Evaluate the relationship between CVPNI to clinical parameter weight during hospitalization | Compare CVPNI changes (∆ mmHg) for high ezCVP subjects during hospitalization to change in measured weight (∆ g) | 7 days | 
| Compare changes in CVPNI to changes in KCCQ quality scores | For each of the 3 Kansas City Cardiomyopathy Questionnaire (KCCQ) totals (integer number with no unit of measure): 1. Overall summary score; 2. clinical summary score; 3. symptom stability score: calculate: ∆KCCQ = KCCQ@14 days - KCCQ@admission. Count number of subjects in each group: ABSOLUTE(∆KCCQ) < 6 (no significant change); ∆KCCQ >= 6 (significant change improvement); ∆KCCQ <= -6 (significant change worsening). Compare to ∆CVPNI (unit = mmHg) = CVPNI-mean@admission - CVPNI-mean@discharge. Count number of subjects in each group: ∆CVPNI <= 0 (no improvement or worsening); ∆CVPNI > 0 & < 5 (improvement); ∆CVPNI > 5 (large improvement). | 21 days | 
| Evaluate the relationship between CVPNI and readmission rate for low and high ezCVP subjects | Compare CVPNI at time of discharge for high ezCVP subjects versus low ezCVP subjects to subsequent readmission occurrence within 90-100 days post hospital discharge. Readmission is a binary value (true or false). | 100 days |