Heart FailurePOCUSPNCT03897647
Use of POC Pocket Ultrasound in the Estimation of Left and Right Atrial Pressures
A study testing General Electric (GE) VScan in people with Heart Failure and Acute Decompensated Heart Failure, run by Montefiore Medical Center.
Trial summary
This study will assess the reliability of POC ultrasound in estimating right and left atrium pressures in patients with acute decompensated heart failure. This study will compare hemodynamic measurements obtained from pulmonary artery catheters with those estimated from POC ultrasound using inferior vena cava (IVC)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Decompensated Heart Failure
- What is being tested?
- General Electric (GE) VScan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2019to 30 Jul 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patients with advanced systolic heart failure (as defined by left ventricular ejection fraction of less than or equal to 35% and New York Heart Association Class III to IV symptoms) who are admitted to the CCU and require hemodynamic monitoring with a Swan-Ganz catheter.
Who cannot join
- Patients supported by mechanical ventilation (intubation or positive pressure ventilation)
- Patients requiring temporary mechanical circulatory support devices (intra-aortic balloon pump, Impella, CentriMag, extracorporeal membrane oxygenation)
- Patients requiring permanent mechanical circulatory support devices (right or left ventricular assist devices)
- Post-cardiac transplantation patients.
About this study
This study will assess the reliability of POC ultrasound in estimating right and left atrium pressures in patients with acute decompensated heart failure. This study will compare hemodynamic measurements obtained from pulmonary artery catheters with those estimated from POC ultrasound using inferior vena cava (IVC) measurements and the presence of atrial septal bulge.
Read the detailed description
For those patients admitted to the CCU who have pulmonary artery catheters placed by the primary team as part of their medical care, the investigators will collect hemodynamic data from their pulmonary artery catheters and echocardiographic data. Echocardiographic and hemodynamic data obtained from pulmonary artery catheters will be simultaneously collected at baseline (within 24 hours of catheter placement) and after 24 and 48 hours of intensive medical therapy if the pulmonary artery catheter is still in place at those times. The placement of the pulmonary artery catheter and the taking of hemodynamic measurements from the catheter will be done as per the primary medical team. The research team will not place any pulmonary artery catheters.
- Conditions
- Heart Failure, Acute Decompensated Heart Failure
- Being tested
- General Electric (GE) VScan
- Keywords
- echocardiography, pulmonary artery catheter, point of care ultrasound
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Electric (GE) VScanDevice
This is a small, point-of-care, hand-held device used for ultrasound (POCUS). It uses sound waves to generate images without using any radiation.
| Study group | Role | What they receive |
|---|---|---|
| POCUS Patients | Experimental | A bedside echocardiogram will be taken using a point-of-care pocket ultrasound (General Electric (GE) Vscan). Central venous pressure (right atrial pressure) and pulmonary capillary wedge pressure (left atrial pressure) will be collected from pulmonary artery catheters. Receives: Device: General Electric (GE) VScan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right atrial pressure at baseline
Right atrial pressure is the pressure in one of the chambers of the heart (the right atrium). It reflects the amount of blood returning to the heart. Normal right atrial pressure is 5 to 10 mm Hg. Low pressures indicate that less blood is returning to the heart than normal, higher pressures indicate that more blood is returning to the heart than normal. Higher pressures can occur for example, in patients with heart failure who are fluid overloaded.
Measured: Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU)
Right atrial pressure at 24 hours
Right atrial pressure is the pressure in one of the chambers of the heart (the right atrium). It reflects the amount of blood returning to the heart. Normal right atrial pressure is 5 to 10 mm Hg. Low pressures indicate that less blood is returning to the heart than normal, higher pressures indicate that more blood is returning to the heart than normal. Higher pressures can occur for example, in patients with heart failure who are fluid overloaded.
Measured: Pressures will be estimated 24 hours after baseline
Right atrial pressure at 48 hours
Right atrial pressure is the pressure in one of the chambers of the heart (the right atrium). It reflects the amount of blood returning to the heart. Normal right atrial pressure is 5 to 10 mm Hg. Low pressures indicate that less blood is returning to the heart than normal, higher pressures indicate that more blood is returning to the heart than normal. Higher pressures can occur for example, in patients with heart failure who are fluid overloaded.
Measured: Pressures will be estimated 48 hours after baseline
Left atrial pressure at baseline
Left atrial pressure is the pressure in one of the chambers of the heart (the left atrium). It represents the filling pressure of the left side of the heart before blood is pumped to the rest of the body. Normal left atrial pressure is 6 to 12 mm Hg. In patients with heart failure, the left atrial pressure may be high due to the heart failing to effectively pump blood to the rest of the body.
Measured: Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU)
Left atrial pressure at 24 hours
Left atrial pressure is the pressure in one of the chambers of the heart (the left atrium). It represents the filling pressure of the left side of the heart before blood is pumped to the rest of the body. Normal left atrial pressure is 6 to 12 mm Hg. In patients with heart failure, the left atrial pressure may be high due to the heart failing to effectively pump blood to the rest of the body.
Measured: Pressures will be estimated 24 hours after baseline
Left atrial pressure at 48 hours
Left atrial pressure is the pressure in one of the chambers of the heart (the left atrium). It represents the filling pressure of the left side of the heart before blood is pumped to the rest of the body. Normal left atrial pressure is 6 to 12 mm Hg. In patients with heart failure, the left atrial pressure may be high due to the heart failing to effectively pump blood to the rest of the body.
Measured: Pressures will be estimated 48 hours after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start31 Jul 2019 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Why it stopped: Administratively closed by the IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario Garcia, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897647
- Sponsor's protocol ID
- 2017-8253
- Acronym
- POCUSP
- Status last verified
- Dec 2019
- First submitted
- 24 May 2018
- Last updated
- 12 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of POC Pocket Ultrasound in the Estimation of Left and Right Atrial Pressures
- ClinicalTrials.gov ID
- NCT03897647
- Acronym / sponsor ID
- POCUSP / 2017-8253
- Conditions
- Heart Failure, Acute Decompensated Heart Failure
- Keywords
- echocardiography, pulmonary artery catheter, point of care ultrasound
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administratively closed by the IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 31 Jul 2019 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 1 Apr 2019 (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.
This study will assess the reliability of POC ultrasound in estimating right and left atrium pressures in patients with acute decompensated heart failure. This study will compare hemodynamic measurements obtained from pulmonary artery catheters with those estimated from POC ultrasound using inferior vena cava (IVC) measurements and the presence of atrial septal bulge.
Detailed description
For those patients admitted to the CCU who have pulmonary artery catheters placed by the primary team as part of their medical care, the investigators will collect hemodynamic data from their pulmonary artery catheters and echocardiographic data. Echocardiographic and hemodynamic data obtained from pulmonary artery catheters will be simultaneously collected at baseline (within 24 hours of catheter placement) and after 24 and 48 hours of intensive medical therapy if the pulmonary artery catheter is still in place at those times. The placement of the pulmonary artery catheter and the taking of hemodynamic measurements from the catheter will be done as per the primary medical team. The research team will not place any pulmonary artery catheters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POCUS Patients | Experimental | Device: General Electric (GE) VScanA bedside echocardiogram will be taken using a point-of-care pocket ultrasound (General Electric (GE) Vscan). Central venous pressure (right atrial pressure) and pulmonary capillary wedge pressure (left atrial pressure) will be collected from pulmonary artery catheters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with advanced systolic heart failure (as defined by left ventricular ejection fraction of less than or equal to 35% and New York Heart Association Class III to IV symptoms) who are admitted to the CCU and require hemodynamic monitoring with a Swan-Ganz catheter.
Key exclusion criteria (4 listed)
- Patients supported by mechanical ventilation (intubation or positive pressure ventilation)
- Patients requiring temporary mechanical circulatory support devices (intra-aortic balloon pump, Impella, CentriMag, extracorporeal membrane oxygenation)
- Patients requiring permanent mechanical circulatory support devices (right or left ventricular assist devices)
- Post-cardiac transplantation patients.
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 |
|---|---|---|
| General Electric (GE) VScanThis is a small, point-of-care, hand-held device used for ultrasound (POCUS). It uses sound waves to generate images without using any radiation. | Device | POCUS Patients |
Primary outcome
Right atrial pressure at baseline
Time frame: Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU)
Right atrial pressure is the pressure in one of the chambers of the heart (the right atrium). It reflects the amount of blood returning to the heart. Normal right atrial pressure is 5 to 10 mm Hg. Low pressures indicate that less blood is returning to the heart than normal, higher pressures indicate that more blood is returning to the heart than normal. Higher pressures can occur for example, in patients with heart failure who are fluid overloaded.
Right atrial pressure at 24 hours
Time frame: Pressures will be estimated 24 hours after baseline
Right atrial pressure is the pressure in one of the chambers of the heart (the right atrium). It reflects the amount of blood returning to the heart. Normal right atrial pressure is 5 to 10 mm Hg. Low pressures indicate that less blood is returning to the heart than normal, higher pressures indicate that more blood is returning to the heart than normal. Higher pressures can occur for example, in patients with heart failure who are fluid overloaded.
Right atrial pressure at 48 hours
Time frame: Pressures will be estimated 48 hours after baseline
Right atrial pressure is the pressure in one of the chambers of the heart (the right atrium). It reflects the amount of blood returning to the heart. Normal right atrial pressure is 5 to 10 mm Hg. Low pressures indicate that less blood is returning to the heart than normal, higher pressures indicate that more blood is returning to the heart than normal. Higher pressures can occur for example, in patients with heart failure who are fluid overloaded.
Left atrial pressure at baseline
Time frame: Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU)
Left atrial pressure is the pressure in one of the chambers of the heart (the left atrium). It represents the filling pressure of the left side of the heart before blood is pumped to the rest of the body. Normal left atrial pressure is 6 to 12 mm Hg. In patients with heart failure, the left atrial pressure may be high due to the heart failing to effectively pump blood to the rest of the body.
Left atrial pressure at 24 hours
Time frame: Pressures will be estimated 24 hours after baseline
Left atrial pressure is the pressure in one of the chambers of the heart (the left atrium). It represents the filling pressure of the left side of the heart before blood is pumped to the rest of the body. Normal left atrial pressure is 6 to 12 mm Hg. In patients with heart failure, the left atrial pressure may be high due to the heart failing to effectively pump blood to the rest of the body.
Left atrial pressure at 48 hours
Time frame: Pressures will be estimated 48 hours after baseline
Left atrial pressure is the pressure in one of the chambers of the heart (the left atrium). It represents the filling pressure of the left side of the heart before blood is pumped to the rest of the body. Normal left atrial pressure is 6 to 12 mm Hg. In patients with heart failure, the left atrial pressure may be high due to the heart failing to effectively pump blood to the rest of the body.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Mario Garcia, MD principal investigator
Montefiore Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing General Electric (GE) VScan in people with Heart Failure and Acute Decompensated Heart Failure, run by Montefiore Medical Center.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 Dec 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Right atrial pressure at baseline (time frame: Pressures will be estimated at baseline (within 24 hours of placement of pulmonary artery catheter upon admission to CCU)). The study lists 6 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 12 Dec 2019.