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

Nihon Kohden

Status: Invitation-only

Conditions: Congestive Heart Failure

Treatments: Device: ezCVP measurement

Study type: Observational

Funder types: Industry

Identifiers

NCT05441696

70Ag_Ogino-00026

Details and patient eligibility

About

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

Full 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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

65 participants in 2 patient groups

Adult CHF subjects with initial high CVP

Description:

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.

Treatment:

Device: ezCVP measurement

Adult CHF subjects with initial low CVP

Description:

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.

Treatment:

Device: ezCVP measurement