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

NCT05441696 | Enrolling By Invitation FDA Device

• 1 other identifier: 70Ag_Ogino-00026
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (2)

• Evaluate the difference between non-invasive CVP measurement at admission and at discharge

  Compare CVPNI at time of admission and discharge in clinical unit CVPNI (CVP subscript NI) is a numeric value equivalence of central venous pressure non-invasive measured in mmHg.

  7 days

• Evaluate the difference between non-invasive CVP measurement in right and left arms

  Compare CVPNI (mmHg) for measurements on left and right arm for same subject

  7 days

Secondary Outcomes (4)

• Evaluate the relationship between CVPNI at discharge and readmission rate

  100 days

• Evaluate the relationship between CVPNI to clinical parameter weight during hospitalization

  7 days

• Compare changes in CVPNI to changes in KCCQ quality scores

  21 days

• Evaluate the relationship between CVPNI and readmission rate for low and high ezCVP subjects

  100 days

Study Arms (2)

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.

Device: ezCVP measurement

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.

Device: ezCVP measurement

Interventions

ezCVP measurement 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 high CVP; Adult CHF subjects with initial low CVP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects admitted due to heart failure exacerbation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nihon Kohden: lead

Study Sites (2)

Veterans Affairs Hospital

Palo Alto, California, 94304, United States

Location

Stanford Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Masataka Kawana, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Patricia Nguyen, MD

  Veterans Affairs Hospital Palo Alto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 1, 2022
• Study Start: June 1, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 29, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)