Status:
ENROLLING_BY_INVITATION
Study for the Evaluation of a Non-invasive Hemodynamic Measurement in Heart Failure Patients
Lead Sponsor:
Nihon Kohden
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 29 2026
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05441696
Start Date
June 1 2022
End Date
September 29 2026
Last Update
December 27 2024
Active Locations (2)
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1
Veterans Affairs Hospital
Palo Alto, California, United States, 94304
2
Stanford Medical Center
Stanford, California, United States, 94305