Pediatric Congestive Heart FailureCV-PRONCT07583680
A Clinical Study Used to Estimate Central Venous Pressure Non-invasively Using Occlusion Pressure
An observational study of Pediatric Congestive Heart Failure and Congestive Heart Failure, run by Le Bonheur Children's Hospital.
Trial summary
The purpose of this study is to collect different measurements using a method called peripheral venous pressure (PVP). PVP checks the pressure in the veins in the arms or legs. It can give doctors a good idea of how well the heart is working, similar to another method called central venous pressure (CVP), which… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pediatric Congestive Heart Failure, Congestive Heart Failure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 17 years
- All sexes
- Child
Study population: Pediatric patients admitted to the Pediatric Intensive Care Unit (PICU) or the Pediatric Cardiac Intensive Care Unit (PCICU) at Le Bonheur Children's Hospital.
Who may be able to join
- Admitted to PICU or PCICU
- Provided written informed consent
- Continuous Central venous pressure monitoring transduced from a standard central venous catheter (not PICC line)
Who cannot join
- Glenn and Fontan Patients
- Heterotaxy Syndrome Patients
- Inability to consent by guardian/caretaker
About this study
Official title: Non-Invasive Central Venous Pressure Estimation Using Occlusion Pressure: A Novel Approach for Accurate Hemodynamic Monitoring
The purpose of this study is to collect different measurements using a method called peripheral venous pressure (PVP). PVP checks the pressure in the veins in the arms or legs. It can give doctors a good idea of how well the heart is working, similar to another method called central venous pressure (CVP), which doctors use in hospitals. In this study, the research team will measure PVP in people aged 0-17. The researcher hopes that this data will help doctors understand how PVP measurements relate to health outcomes, which could lead to better ways to diagnose and treat patients in the future.
The peripheral venous pressure (PVP) device will be used to non-invasively measure the pressure required to stop blood flow in the forearm, which will indirectly measure the PVP in the forearm. This device is composed of a pressure sensor and a Doppler flow detector that will be connected to a research laptop for data collection. This device will be placed on the forearm.
Read more
If you agree to be in this study, the study team will monitor the venous flow rate (the amount of blood moving through the veins over a certain period of time) using a Doppler Flow Detector while applying pressure to the vein with a pressure sensor. This will take place on the forearm.
The internal jugular vein will be identified and recorded using ultrasound imaging and Doppler sensor.
The forearm vein will be identified and marked using ultrasound imaging. Pressure will be applied for 15 seconds, and then stopped and repeated 4 times, making five sets of measurements.
The procedure may be repeated in 2-3 additional sessions during the hospital stay, if necessary.
Your participation in this study will last approximately 30 minutes.
This procedure is for research only and will not affect your regular care. This will occur during your child's stay in the PCICU/PICU. No additional study visits will be required.
The following procedures are being performed for research purposes only:
Copying information such as your medical history from your medical record; Obtaining non-invasive peripheral venous pressure measurements.
Read the detailed description
Pediatric congestive heart failure (CHF) is a complex, often end-stage condition affecting around 35,000 children annually in the U.S., with 14,000 hospitalizations and a 6.3% in-hospital mortality rate. CHF occurs when the heart can't meet circulatory demands, leading to increased central venous pressure (CVP), which is currently measured invasively.
In outpatient pediatric care, CHF monitoring relies on subjective symptom reporting and potentially inaccurate weight measurements resulting in a 50% misdiagnosis rate. Recent studies indicate a strong correlation between peripheral venous pressure (PVP) and CVP, suggesting that noninvasive PVP measurements, obtained through occlusion pressure, could accurately estimate CVP.
To test this, the researcher developed a proof-of-concept study using ultrasound, Doppler transducers, and pressure sensors to measure occlusion pressure in veins. This data will be calibrated against direct CVP measurements from central lines using linear regression. The goal is to enhance outpatient monitoring for pediatric CHF, improving diagnostic accuracy by integrating inpatient methods into outpatient settings.
This study will push forward the development of an innovation in pediatric outpatient monitoring, aiming to bring the accuracy and precision of inpatient monitoring into the outpatient settings.
- Keywords
- CHF, Pediatric CHF, Congenital Heart Disease, Pediatric Congenital Heart Disease, Pediatric Congestive Heart Failure, Congestive Heart Failure, Heart Failure, CVP, Central Venous Pressure, CVP Monitor
- Medical subject headings
- Heart Failure, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Participants Admitted to the ICU with a Central Venous Catheter | All participants in the study admitted to a pediatric ICU with a central venous catheter in place. | |
| Variable CVP Subset | A subset of approximately 5 participants that have varying ranges of central venous pressure throughout their hospitalization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute error (MAE) between non-invasive estimated central venous pressure (Doppler-coupled occlusion-pressure device) and invasive central venous pressure (central venous catheter)
Unit of Measure: mmHg For each participant, the non-invasive estimated CVP value derived from the Doppler-coupled occlusion-pressure measurement (5 technical replicates per session) will be compared to the simultaneous invasive CVP value obtained from the central venous catheter (standard of care). The primary reportable outcome is the MAE across participants, defined as the mean of the absolute difference between paired estimated and measured CVP values, expressed in mmHg. The pre-specified target is MAE ≤ 2 mmHg, consistent with the sample-size justification (n=25 to achieve 80% power assuming an acceptable margin of error of 2 mmHg, a Type I error rate of 5%, and an expected standard deviation of 4 mmHg from prior literature). Intermediate algorithm inputs including vein-occlusion pressure, initial vein diameter, Doppler-isolated venous waveform characteristics, internal jugular vein Doppler recording, and intrapatient and interpatient variability of device output.
Measured: At time of single study session, up to 60 minutes
Secondary outcomes (1)
Correlation between non-invasive estimated central venous pressure and invasive central venous pressure, adjusted for concurrent physiologic context variables abstracted from the electronic medical record
Unit of Measure: Pearson correlation coefficient (r), unitless, range -1.00 to +1.00 Strength of the linear association between the non-invasive estimated CVP (Doppler-coupled occlusion-pressure device) and simultaneous invasive CVP (central venous catheter). The regression model will adjust for concurrent physiologic context variables abstracted from the EMR at the single study session - collected as standard of care, with no extra research procedures: heart rate, cardiac rhythm, respiratory rate, non-invasive and arterial-line blood pressure (systolic, diastolic, MAP), SpO2, ETCO2, awRR, mixed venous oxygen saturation, stroke volume, cardiac output, and intracardiac chamber pressures. Only readily available EMR parameters will be recorded; no procedures will be added to obtain missing data.
Measured: At time of single study session, up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Le Bonheur Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Brett Boyer Foundation
- Responsible party
- Principal investigator, Danielle Gottlieb Sen, Le Bonheur Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583680
- Sponsor's protocol ID
- 25-10829-FB: CV-PRO
- Acronym
- CV-PRO
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Central Venous Pressure Estimation Using Occlusion Pressure: A Novel Approach for Accurate Hemodynamic Monitoring
- ClinicalTrials.gov ID
- NCT07583680
- Acronym / sponsor ID
- CV-PRO / 25-10829-FB: CV-PRO
- Keywords
- CHF, Pediatric CHF, Congenital Heart Disease, Pediatric Congenital Heart Disease, Pediatric Congestive Heart Failure, Congestive Heart Failure, Heart Failure, CVP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Le Bonheur Children's HospitalUniversity, hospital or other
- Collaborators
- The Brett Boyer Foundation
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 May 2026 (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.
The purpose of this study is to collect different measurements using a method called peripheral venous pressure (PVP). PVP checks the pressure in the veins in the arms or legs. It can give doctors a good idea of how well the heart is working, similar to another method called central venous pressure (CVP), which doctors use in hospitals. In this study, the research team will measure PVP in people aged 0-17. The researcher hopes that this data will help doctors understand how PVP measurements relate to health outcomes, which could lead to better ways to diagnose and treat patients in the future.
The peripheral venous pressure (PVP) device will be used to non-invasively measure the pressure required to stop blood flow in the forearm, which will indirectly measure the PVP in the forearm. This device is composed of a pressure sensor and a Doppler flow detector that will be connected to a research laptop for data collection. This device will be placed on the forearm.
If you agree to be in this study, the study team will monitor the venous flow rate (the amount of blood moving through the veins over a certain period of time) using a Doppler Flow Detector while applying pressure to the vein with a pressure sensor. This will take place on the forearm.
The internal jugular vein will be identified and recorded using ultrasound imaging and Doppler sensor.
The forearm vein will be identified and marked using ultrasound imaging. Pressure will be applied for 15 seconds, and then stopped and repeated 4 times, making five sets of measurements.
The procedure may be repeated in 2-3 additional sessions during the hospital stay, if necessary.
Your participation in this study will last approximately 30 minutes.
This procedure is for research only and will not affect your regular care. This will occur during your child's stay in the PCICU/PICU. No additional study visits will be required.
The following procedures are being performed for research purposes only:
Copying information such as your medical history from your medical record; Obtaining non-invasive peripheral venous pressure measurements.
Detailed description
Pediatric congestive heart failure (CHF) is a complex, often end-stage condition affecting around 35,000 children annually in the U.S., with 14,000 hospitalizations and a 6.3% in-hospital mortality rate. CHF occurs when the heart can't meet circulatory demands, leading to increased central venous pressure (CVP), which is currently measured invasively.
In outpatient pediatric care, CHF monitoring relies on subjective symptom reporting and potentially inaccurate weight measurements resulting in a 50% misdiagnosis rate. Recent studies indicate a strong correlation between peripheral venous pressure (PVP) and CVP, suggesting that noninvasive PVP measurements, obtained through occlusion pressure, could accurately estimate CVP.
To test this, the researcher developed a proof-of-concept study using ultrasound, Doppler transducers, and pressure sensors to measure occlusion pressure in veins. This data will be calibrated against direct CVP measurements from central lines using linear regression. The goal is to enhance outpatient monitoring for pediatric CHF, improving diagnostic accuracy by integrating inpatient methods into outpatient settings.
This study will push forward the development of an innovation in pediatric outpatient monitoring, aiming to bring the accuracy and precision of inpatient monitoring into the outpatient settings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric Participants Admitted to the ICU with a Central Venous Catheter | – | –All participants in the study admitted to a pediatric ICU with a central venous catheter in place. |
| Variable CVP Subset | – | –A subset of approximately 5 participants that have varying ranges of central venous pressure throughout their hospitalization. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Pediatric patients admitted to the Pediatric Intensive Care Unit (PICU) or the Pediatric Cardiac Intensive Care Unit (PCICU) at Le Bonheur Children's Hospital.
Key inclusion criteria (3 listed)
- Admitted to PICU or PCICU
- Provided written informed consent
- Continuous Central venous pressure monitoring transduced from a standard central venous catheter (not PICC line)
Key exclusion criteria (3 listed)
- Glenn and Fontan Patients
- Heterotaxy Syndrome Patients
- Inability to consent by guardian/caretaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean absolute error (MAE) between non-invasive estimated central venous pressure (Doppler-coupled occlusion-pressure device) and invasive central venous pressure (central venous catheter)
Time frame: At time of single study session, up to 60 minutes
Unit of Measure: mmHg For each participant, the non-invasive estimated CVP value derived from the Doppler-coupled occlusion-pressure measurement (5 technical replicates per session) will be compared to the simultaneous invasive CVP value obtained from the central venous catheter (standard of care). The primary reportable outcome is the MAE across participants, defined as the mean of the absolute difference between paired estimated and measured CVP values, expressed in mmHg. The pre-specified target is MAE ≤ 2 mmHg, consistent with the sample-size justification (n=25 to achieve 80% power assuming an acceptable margin of error of 2 mmHg, a Type I error rate of 5%, and an expected standard deviation of 4 mmHg from prior literature). Intermediate algorithm inputs including vein-occlusion pressure, initial vein diameter, Doppler-isolated venous waveform characteristics, internal jugular vein Doppler recording, and intrapatient and interpatient variability of device output.
1 secondary outcome
Correlation between non-invasive estimated central venous pressure and invasive central venous pressure, adjusted for concurrent physiologic context variables abstracted from the electronic medical record
Time frame: At time of single study session, up to 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Related trials for Pediatric Congestive Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
Enrolling by invitation
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Heart Failure, Transplant; Failure, Heart
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Not yet recruitingPhase 4
A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients
Edema Due to Heart Failure or Cirrhosis
RecruitingObservational study
Exploratory Study on Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Acute and Critical Care Setting
Heart Failure
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Congestive Heart Failure and Congestive Heart Failure, run by Le Bonheur Children's Hospital.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Mean absolute error (MAE) between non-invasive estimated central venous pressure (Doppler-coupled occlusion-pressure device) and invasive central venous pressure (central venous catheter) (time frame: At time of single study session, up to 60 minutes). 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 13 May 2026.