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

NCT05441696 · tracked via the Priya Life Science USA tracker

Sponsor

Nihon Kohden

Phase

Observational

Started

2022-06-01

Last updated

2024-12-27

Condition(s) studied

Congestive Heart Failure

Investigational drug(s) / intervention(s)

ezCVP measurement

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).

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

Evaluate the difference between non-invasive CVP measurement at admission and at discharge — 7 days
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.
Evaluate the difference between non-invasive CVP measurement in right and left arms — 7 days
Compare CVPNI (mmHg) for measurements on left and right arm for same subject

Trial sites (2)

Facility	City	Region	Status
Veterans Affairs Hospital	Palo Alto	California
Stanford Medical Center	Stanford	California

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Other trials for the same condition

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Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction Recruiting

Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05441696 on ClinicalTrials.gov ↗ ← All trials in the USA