Congestive Heart FailureNCT05441696
Study for the Evaluation of a Non-invasive Hemodynamic Measurement in Heart Failure Patients
An observational study of Congestive Heart Failure, run by Nihon Kohden at 2 sites in United States.
Trial summary
Track changes in non-invasive central venous pressure across hospital stay and relationship with readmission Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- ezCVP measurement
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2022to 29 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects admitted due to heart failure exacerbation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Veterans Affairs Hospital
Palo Alto, California, 94304
Stanford Medical Center
Stanford, California, 94305
About this study
Official title: Pilot Study for the Evaluation of EzCVP in Heart Failure Patients
Track changes in non-invasive central venous pressure across hospital stay and relationship with readmission
Read the 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
- Being tested
- ezCVP measurement
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ezCVP measurementDevice
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: ezCVP measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 7 days
Secondary outcomes (4)
Evaluate the relationship between CVPNI at discharge and readmission rate
Compare CVPNI (mmHg) at time of discharge for high ezCVP subjects to subsequent readmission occurrence within 90-100 days post hospital discharge
Measured: 100 days
Evaluate the relationship between CVPNI to clinical parameter weight during hospitalization
Compare CVPNI changes (∆ mmHg) for high ezCVP subjects during hospitalization to change in measured weight (∆ g)
Measured: 7 days
Compare changes in CVPNI to changes in KCCQ quality scores
For each of the 3 Kansas City Cardiomyopathy Questionnaire (KCCQ) totals (integer number with no unit of measure): 1. Overall summary score; 2. clinical summary score; 3. symptom stability score: calculate: ∆KCCQ = KCCQ@14 days - KCCQ@admission. Count number of subjects in each group: ABSOLUTE(∆KCCQ) < 6 (no significant change); ∆KCCQ >= 6 (significant change improvement); ∆KCCQ <= -6 (significant change worsening).
Compare to ∆CVPNI (unit = mmHg) = CVPNI-mean@admission - CVPNI-mean@discharge. Count number of subjects in each group: ∆CVPNI <= 0 (no improvement or worsening); ∆CVPNI > 0 \& < 5 (improvement); ∆CVPNI > 5 (large improvement).
Measured: 21 days
Evaluate the relationship between CVPNI and readmission rate for low and high ezCVP subjects
Compare CVPNI at time of discharge for high ezCVP subjects versus low ezCVP subjects to subsequent readmission occurrence within 90-100 days post hospital discharge. Readmission is a binary value (true or false).
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Jun 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nihon Kohden
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masataka Kawana, MD, Principal investigator, Stanford UniversityPatricia Nguyen, MD, Principal investigator, Veterans Affairs Hospital Palo Alto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441696
- Sponsor's protocol ID
- 70Ag_Ogino-00026
- Status last verified
- Mar 2024
- First submitted
- 21 Jun 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be shared. Aggregate results will be published by the investigators in academic journals.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Evaluation of EzCVP in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT05441696
- Acronym / sponsor ID
- 70Ag_Ogino-00026
- Conditions
- Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Nihon KohdenIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult CHF subjects with initial high CVP | – | Device: ezCVP measurementAdult subjects with congestive heart failure diagnosis who have an indicated high non-invasive estimated central venous pressure on first measurement after clinical unit admission. |
| Adult CHF subjects with initial low CVP | – | Device: ezCVP measurementAdult subjects with congestive heart failure diagnosis who have an indicated low non-invasive estimated central venous pressure on first measurement after clinical unit admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects admitted due to heart failure exacerbation
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Adult CHF subjects with initial high CVP, Adult CHF subjects with initial low CVP |
Primary outcome
Evaluate the difference between non-invasive CVP measurement at admission and at discharge
Time frame: 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
Time frame: 7 days
Compare CVPNI (mmHg) for measurements on left and right arm for same subject
4 secondary outcomes
Evaluate the relationship between CVPNI at discharge and readmission rate
Time frame: 100 days
Evaluate the relationship between CVPNI to clinical parameter weight during hospitalization
Time frame: 7 days
Compare changes in CVPNI to changes in KCCQ quality scores
Time frame: 21 days
Evaluate the relationship between CVPNI and readmission rate for low and high ezCVP subjects
Time frame: 100 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. No individual participant data will be shared. Aggregate results will be published by the investigators in academic journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masataka Kawana, MD principal investigator
Stanford University
Patricia Nguyen, MD principal investigator
Veterans Affairs Hospital Palo Alto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Nihon Kohden at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the difference between non-invasive CVP measurement at admission and at discharge (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.