Heart Failure Clinical Trial

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

Summary

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

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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.

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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

Study is for people with:

Heart Failure

Estimated Enrollment:

65

Study ID:

NCT05441696

Recruitment Status:

Enrolling by invitation

Sponsor:

Nihon Kohden

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There are 2 Locations for this study

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

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Study is for people with:

Heart Failure

Estimated Enrollment:

65

Study ID:

NCT05441696

Recruitment Status:

Enrolling by invitation

Sponsor:


Nihon Kohden

How clear is this clinincal trial information?

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