Study for the Evaluation of a Non-invasive Hemodynamic Measurement in Heart Failure Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ezCVP measurement.
- Who it may be relevant to
- Registry conditions: Congestive Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study for the Evaluation of EzCVP in Heart Failure Patients
Overview
Track changes in non-invasive central venous pressure across hospital stay and relationship with readmission
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.
Interventions
- 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).
Primary outcome measures
- Evaluate the difference between non-invasive CVP measurement at admission and at discharge [Time frame: 7 days]
- Evaluate the difference between non-invasive CVP measurement in right and left arms [Time frame: 7 days]
Secondary outcome measures (4)
- Evaluate the relationship between CVPNI at discharge and readmission rate [Time frame: 100 days]
- Evaluate the relationship between CVPNI to clinical parameter weight during hospitalization [Time frame: 7 days]
- Compare changes in CVPNI to changes in KCCQ quality scores [Time frame: 21 days]
- Evaluate the relationship between CVPNI and readmission rate for low and high ezCVP subjects [Time frame: 100 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Veterans Affairs Hospital — Palo Alto
- Stanford Medical Center — Stanford
Identifiers
NCT: NCT05441696 · 70Ag_Ogino-00026