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

NCT ID: NCT05441696

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2026-09-29

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.

Conditions

Congestive Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

ezCVP measurement

Intervention Type: DEVICE

• 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.

ezCVP measurement

Intervention Type: DEVICE

• 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).

Interventions

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nihon Kohden

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masataka Kawana, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Patricia Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Veterans Affairs Hospital Palo Alto

Locations

Veterans Affairs Hospital

Palo Alto, California, United States

Stanford Medical Center

Stanford, California, United States

Countries

United States

Other Identifiers

70Ag_Ogino-00026

Identifier Type: -

Identifier Source: org_study_id