Clinical trial NCT05441696: Study for the Evaluation of a Non-invasive Hemodynamic Measurement in Heart Failure Patients
Official title: Pilot Study for the Evaluation of EzCVP in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Congestive Heart Failure
Lead sponsor: Nihon Kohden
Sponsor class: INDUSTRY
First posted: 2022-07-01
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects admitted due to heart failure exacerbation

Brief summary: 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.

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

Primary outcomes:
measure: Evaluate the difference between non-invasive CVP measurement at admission and at discharge
timeFrame: 7 days
measure: Evaluate the difference between non-invasive CVP measurement in right and left arms
timeFrame: 7 days
Secondary outcomes:
measure: Evaluate the relationship between CVPNI at discharge and readmission rate
timeFrame: 100 days
measure: Evaluate the relationship between CVPNI to clinical parameter weight during hospitalization
timeFrame: 7 days
measure: Compare changes in CVPNI to changes in KCCQ quality scores
timeFrame: 21 days
measure: Evaluate the relationship between CVPNI and readmission rate for low and high ezCVP subjects
timeFrame: 100 days
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Veterans Affairs Hospital
state: California
city: Stanford
country: United States
facility: Stanford Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Masataka Kawana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Veterans Affairs Hospital Palo Alto
name: Patricia Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: