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

Pilot Study for the Evaluation of ezCVP in Heart Failure Patients

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Device: ezCVP measurement

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 65

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Veterans Affairs Hospital
    • Stanford, California, United States, 94305
      • Stanford Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects admitted due to heart failure exacerbation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult CHF subjects with initial high CVP; 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; 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).
Adult CHF subjects with initial low CVP; 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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nihon Kohden
• Investigators: Principal Investigator: Masataka Kawana, MD, Stanford University; Principal Investigator: Patricia Nguyen, MD, Veterans Affairs Hospital Palo Alto

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 29, 2025

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 70Ag_Ogino-00026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared. Aggregate results will be published by the investigators in academic journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No