Acute Heart FailureNCT06533124
Parameters of Cardiac Indices on the Ultrasonic Cardiac Output Monitor As Potential Indicators for Predicting the Achievement of Ultrafiltration Endpoint for Acute Heart Failure Treatment
A study testing The ultrasonic cardiac output monitor 1A system (USCOM Ltd., Sydney, Australia) is a non-invasive Doppler stroke volume (SV) technique derived from echocardiography. in people with Acute Heart Failure, run by Shanghai Tong Ren Hospital at 1 site in China.
Trial summary
Background: The feasibility of the ultrasonic cardiac output monitor (USCOM)applying for determining ultrafiltration (UF) endpoints during acute heart failure (AHF) treatments was evaluated. Methods: AHF patients were randomly assigned to UF (U, N=20) and USCOM+UF (UU, N=20) groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- The ultrasonic cardiac output monitor 1A system (USCOM Ltd., Sydney, Australia) is a non-invasive Doppler stroke volume (SV) technique derived from echocardiography.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2022to 1 Aug 2023
- 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
- Age ≥ 18 years.
- Male or non-pregnant female patients.
- Fluid overload manifested by at least two of the following:
- Pitting edema ≥ 2+ of the lower extremities
- Moist rales in the lungs
- Jugular venous distention \> 10 cm
Show all 10Show fewer
- Pulmonary edema or pleural effusion on chest x-ray
- Paroxysmal nocturnal dyspnea or ≥ two-pillow orthopnea
- Congestive hepatomegaly or ascites
- B-type natriuretic peptide (BNP) \> 400 pg/mL
Who cannot join
- Hematocrit \> 45%.
- Systolic blood pressure ≤ 90 mmHg and poor peripheral circulation.
- Contraindications to heparin anticoagulation.
- Renal insufficiency with a Scr ≥ 3.0 mg/dl or planned renal replacement therapies.
- Acute coronary syndromes.
- Life-threatening organ dysfunction caused by a dysregulated host response to infection.
Show all 13Show fewer
- Active myocarditis.
- patients with heart failure attributed to restrictive or hypertrophic cardiomyopathy or uncorrected valvular stenotic disease.
- infection.
- malignancies.
- systemic immune disease.
- unwillingness to cooperate.
- withdrawal from the study or death.
Trial locations and contacts
1 site in 1 country.
About this study
Background: The feasibility of the ultrasonic cardiac output monitor (USCOM)applying for determining ultrafiltration (UF) endpoints during acute heart failure (AHF) treatments was evaluated.
Methods: AHF patients were randomly assigned to UF (U, N=20) and USCOM+UF (UU, N=20) groups. The primary endpoint was differences in the hemodynamics of patients receiving UF alone or UF+USCOM. A prediction model was established.
Read the detailed description
This study was based on the ACC/AHA/HFSA guidelines for the management of heart failure and involved 40 patients diagnosed with acute decompensated heart failure (ADHF) from January 2022 to July 2023. Patients were randomly assigned to UF (U, N = 20) and USCOM + UF (UU, N = 20) groups.
The inclusion criteria were: (1) Age ≥ 18 years; (2) Male or non-pregnant female patients; (3) Fluid overload manifested by at least two of the following: a) Pitting edema ≥ 2+ of the lower extremities; b) Moist rales in the lungs; c) Jugular venous distention > 10 cm; d) Pulmonary edema or pleural effusion on chest x-ray; e) Paroxysmal nocturnal dyspnea or ≥ two-pillow orthopnea; f) Congestive hepatomegaly or ascites; e) B-type natriuretic peptide (BNP) > 400 pg/mL.
The exclusion criteria were: (1) Hematocrit > 45%; (2) Systolic blood pressure ≤ 90 mmHg and poor peripheral circulation; (3) Contraindications to heparin anticoagulation;(4) Renal insufficiency with a Scr ≥ 3.0 mg/dl or planned renal replacement therapies; (5) Acute coronary syndromes; (6) Life-threatening organ dysfunction caused by a dysregulated host response to infection; (7) Active myocarditis; (8) patients with heart failure attributed to restrictive or hypertrophic cardiomyopathy or uncorrected valvular stenotic disease; (9) infection; (10) malignancies; (11) systemic immune disease; (12) unwillingness to cooperate; (13) withdrawal from the study or death. The study adhered to the principles of the Declaration of Helsinki and the protocols were approved by the Institutional Review Board of our hospital (2019-072-01). Informed consent was obtained from all enrolled patients.
Randomization:
Patients were randomly assigned in a 1:1 ratio, with one group receiving UF treatment alone and the other receiving UF treatment plus USCOM monitoring. The allocation of study participants was processed through an interactive web response system with a non-stratified permutated block size. Treating clinicians were unaware of patients' group assignments; there were a total of 40 patients.
The operator steps of USCOM The operation of USCOM only requires placing the probe in the patient's pulmonary artery window or aortic window for monitoring. In pulmonary artery window monitoring, the probe is positioned beside the right sternal border or upper abdomen to assess blood flow in the pulmonary artery, thereby monitoring pulmonary circulation and right heart function. For aortic window monitoring, the probe is placed at the sternal notch or subclavian fossa (same as the pulmonary artery window), and measurements are taken through the aorta to assess systemic circulation, primarily monitoring left ventricular output. In this study, only one skilled operator monitored all UU group patients.
Assessments Patients were assessed at baseline and throughout the period of treatment. The documented variables were medical history, physical examination data, echocardiography, laboratory blood test monitoring (continuous), including the total UF volume, body weight, patient symptoms, body position, transcutaneous oxygen saturation, degree of edema, leg circumference, abdominal circumference, input-output balance and other variables for 7 days. Adverse events (AEs) were assessed and documented by clinicians within 24 h.
In the USCOM plus UF group, cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output. The monitored parameters included the SV index (SVI), SV variation (SVV), cardiac output (CO), cardiac index (CI), inotropy (INO), systemic vascular resistance index (SVRI), systemic vascular resistance (SVR), flow time corrected (FTC) and the velocity time integral (VTI) USCOM. Thresholds of a 30% or 50% reduction in BNP relative to baseline were set as criteria for reaching the UF endpoint.
Endpoints The primary endpoint was differences in the hemodynamics of patients in the UF alone and UF plus USCOM groups during UF, monitored at 1, 2, 3, 4 and 7 days. The secondary endpoints were the identification of one or more indicators on the USCOM monitor that could predict the endpoint of UF. Additionally, the study assessed the economic benefits between the two groups.
Statistical analysis All analyses and calculations of sample size were performed using SPSS. Student's t-test or analysis of variance (ANOVA) was used to look for differences in continuous regularly distributed variables, and the Kruskal-Wallis test was employed to determine whether there were significant group differences. The findings are presented as the mean ± SD. A Mann-Whitney U test or Wilcoxon rank sum test was used for continuous variables that were not normally distributed, and the results are reported as median (Q1, Q3). To assess potential differences between categorical variables, a χ² test or Fisher's exact test was used for analysis. P-values < 0.05 were deemed to be significant.
- Conditions
- Acute Heart Failure
- Being tested
- The ultrasonic cardiac output monitor 1A system (USCOM Ltd., Sydney, Australia) is a non-invasive Doppler stroke volume (SV) technique derived from echocardiography.
- Keywords
- Ultrasonic cardiac output monitor (USCOM), Acute heart failure, Brain natriuretic peptide, Ultrafiltration, Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ultrasonic cardiac output monitor 1A system (USCOM Ltd., Sydney, Australia) is a non-invasive Doppler stroke volume (SV) technique derived from echocardiography.Device
In the USCOM + ultrafiltration group, cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output. The monitored parameters include, SV index (SVI), SV variation (SVV), cardiac output (CO), cardiac index (CI), inotropy (INO), systemic vascular resistance index (SVRI), systemic vascular resistance (SVR), flow time corrected (FTC) and velocity time integral (VTI) .
| Study group | Role | What they receive |
|---|---|---|
| USCOM + ultrafiltration group-experimental group | Experimental | In the USCOM + ultrafiltration group, cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output. The monitored parameters include, SV index (SVI), SV variation (SVV), cardiac output (CO), cardiac index (CI), inotropy (INO), systemic vascular resistance index (SVRI), systemic vascular resistance (SVR), flow time corrected (FTC) and velocity time integral (VTI) . Receives: Device: The ultrasonic cardiac output monitor 1A system (USCOM Ltd., Sydney, Australia) is a non-invasive Doppler stroke volume (SV) technique derived from echocardiography. |
| ultrafiltration group-control group | No intervention | Patients who met the criteria for ultrafiltration were treated with conventional ultrafiltration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
SVV, systemic vascular variation, unit of mesure:%
Measured: One week
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
SVI, systemic vascular index , unit of mesure: ml/m2
Measured: One week
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
CI, cardiac index, unit of measure: l/min/m2.
Measured: One week
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
INO, inotropy, unit of measure: w/m2
Measured: One week
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
CO, cardiac output, unit of measure: l/min.
Measured: One week
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
SVRI, systemic vascular resistance index, unit of measure: ds cm-5m2.
Measured: One week
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
SVR, systemic vascular resistance index, unit of measure: ds cm-5.
Measured: One week
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
FTC, flow time corrected, unit of measure: ms.
Measured: One week
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
VTI, velocity time integral, unit of measure: cm.
Measured: One week
Brain natriuretic peptide
BNP, Brain natriuretic peptide, unit of measure: pg/ml.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start5 Jan 2022
- Primary completion5 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly assigned in a 1:1 ratio, with one group receiving UF treatment alone and the other receiving UF treatment plus USCOM monitoring. The allocation of study participants was processed through an interactive web response system with a non-stratified permutated block size. Treating clinicians were unaware of patients' group assignments; there were a total of 40 patients.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Tong Ren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533124
- Sponsor's protocol ID
- 2019-072-01
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li Y, Chen J, Bian J, Chen F, Wan Q, Yuan F. Cardiac Indices Parameters on the Ultrasonic Cardiac Output Monitor as Potential Indicators to Predict the Ultrafiltration Endpoint Success in Acute Heart Failure Treatment. Rev Cardiovasc Med. 2025 May 22;26(5):27100. doi: 10.31083/RCM27100. eCollection 2025 May.
PubMed 40475748
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parameters of Cardiac Indices on the Ultrasonic Cardiac Output Monitor As Potential Indicators for Predicting the Achievement of Ultrafiltration Endpoint for Acute Heart Failure Treatment
- ClinicalTrials.gov ID
- NCT06533124
- Acronym / sponsor ID
- 2019-072-01
- Conditions
- Acute Heart Failure
- Keywords
- Ultrasonic cardiac output monitor (USCOM), Acute heart failure, Brain natriuretic peptide, Ultrafiltration, Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Tong Ren HospitalUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 1 Aug 2024 (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.
Background: The feasibility of the ultrasonic cardiac output monitor (USCOM)applying for determining ultrafiltration (UF) endpoints during acute heart failure (AHF) treatments was evaluated.
Methods: AHF patients were randomly assigned to UF (U, N=20) and USCOM+UF (UU, N=20) groups. The primary endpoint was differences in the hemodynamics of patients receiving UF alone or UF+USCOM. A prediction model was established.
Detailed description
This study was based on the ACC/AHA/HFSA guidelines for the management of heart failure and involved 40 patients diagnosed with acute decompensated heart failure (ADHF) from January 2022 to July 2023. Patients were randomly assigned to UF (U, N = 20) and USCOM + UF (UU, N = 20) groups.
The inclusion criteria were: (1) Age ≥ 18 years; (2) Male or non-pregnant female patients; (3) Fluid overload manifested by at least two of the following: a) Pitting edema ≥ 2+ of the lower extremities; b) Moist rales in the lungs; c) Jugular venous distention > 10 cm; d) Pulmonary edema or pleural effusion on chest x-ray; e) Paroxysmal nocturnal dyspnea or ≥ two-pillow orthopnea; f) Congestive hepatomegaly or ascites; e) B-type natriuretic peptide (BNP) > 400 pg/mL.
The exclusion criteria were: (1) Hematocrit > 45%; (2) Systolic blood pressure ≤ 90 mmHg and poor peripheral circulation; (3) Contraindications to heparin anticoagulation;(4) Renal insufficiency with a Scr ≥ 3.0 mg/dl or planned renal replacement therapies; (5) Acute coronary syndromes; (6) Life-threatening organ dysfunction caused by a dysregulated host response to infection; (7) Active myocarditis; (8) patients with heart failure attributed to restrictive or hypertrophic cardiomyopathy or uncorrected valvular stenotic disease; (9) infection; (10) malignancies; (11) systemic immune disease; (12) unwillingness to cooperate; (13) withdrawal from the study or death. The study adhered to the principles of the Declaration of Helsinki and the protocols were approved by the Institutional Review Board of our hospital (2019-072-01). Informed consent was obtained from all enrolled patients.
Randomization:
Patients were randomly assigned in a 1:1 ratio, with one group receiving UF treatment alone and the other receiving UF treatment plus USCOM monitoring. The allocation of study participants was processed through an interactive web response system with a non-stratified permutated block size. Treating clinicians were unaware of patients' group assignments; there were a total of 40 patients.
The operator steps of USCOM The operation of USCOM only requires placing the probe in the patient's pulmonary artery window or aortic window for monitoring. In pulmonary artery window monitoring, the probe is positioned beside the right sternal border or upper abdomen to assess blood flow in the pulmonary artery, thereby monitoring pulmonary circulation and right heart function. For aortic window monitoring, the probe is placed at the sternal notch or subclavian fossa (same as the pulmonary artery window), and measurements are taken through the aorta to assess systemic circulation, primarily monitoring left ventricular output. In this study, only one skilled operator monitored all UU group patients.
Assessments Patients were assessed at baseline and throughout the period of treatment. The documented variables were medical history, physical examination data, echocardiography, laboratory blood test monitoring (continuous), including the total UF volume, body weight, patient symptoms, body position, transcutaneous oxygen saturation, degree of edema, leg circumference, abdominal circumference, input-output balance and other variables for 7 days. Adverse events (AEs) were assessed and documented by clinicians within 24 h.
In the USCOM plus UF group, cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output. The monitored parameters included the SV index (SVI), SV variation (SVV), cardiac output (CO), cardiac index (CI), inotropy (INO), systemic vascular resistance index (SVRI), systemic vascular resistance (SVR), flow time corrected (FTC) and the velocity time integral (VTI) USCOM. Thresholds of a 30% or 50% reduction in BNP relative to baseline were set as criteria for reaching the UF endpoint.
Endpoints The primary endpoint was differences in the hemodynamics of patients in the UF alone and UF plus USCOM groups during UF, monitored at 1, 2, 3, 4 and 7 days. The secondary endpoints were the identification of one or more indicators on the USCOM monitor that could predict the endpoint of UF. Additionally, the study assessed the economic benefits between the two groups.
Statistical analysis All analyses and calculations of sample size were performed using SPSS. Student's t-test or analysis of variance (ANOVA) was used to look for differences in continuous regularly distributed variables, and the Kruskal-Wallis test was employed to determine whether there were significant group differences. The findings are presented as the mean ± SD. A Mann-Whitney U test or Wilcoxon rank sum test was used for continuous variables that were not normally distributed, and the results are reported as median (Q1, Q3). To assess potential differences between categorical variables, a χ² test or Fisher's exact test was used for analysis. P-values < 0.05 were deemed to be significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients were randomly assigned in a 1:1 ratio, with one group receiving UF treatment alone and the other receiving UF treatment plus USCOM monitoring. The allocation of study participants was processed through an interactive web response system with a non-stratified permutated block size. Treating clinicians were unaware of patients' group assignments; there were a total of 40 patients.
| Arm | Type | Receives |
|---|---|---|
| USCOM + ultrafiltration group-experimental group | Experimental | Device: The ultrasonic cardiac output monitor 1A system (USCOM Ltd., Sydney, Australia) is a non-invasive Doppler stroke volume (SV) technique derived from echocardiography.In the USCOM + ultrafiltration group, cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output. The monitored parameters include, SV index (SVI), SV variation (SVV), cardiac output (CO), cardiac index (CI), inotropy (INO), systemic vascular resistance index (SVRI), systemic vascular resistance (SVR), flow time corrected (FTC) and velocity time integral (VTI) . |
| ultrafiltration group-control group | No intervention | –Patients who met the criteria for ultrafiltration were treated with conventional ultrafiltration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years.
- Male or non-pregnant female patients.
- Fluid overload manifested by at least two of the following:
Key exclusion criteria (13 listed)
- Hematocrit \&gt; 45%.
- Systolic blood pressure ≤ 90 mmHg and poor peripheral circulation.
- Contraindications to heparin anticoagulation.
- Renal insufficiency with a Scr ≥ 3.0 mg/dl or planned renal replacement therapies.
- Acute coronary syndromes.
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 |
|---|---|---|
| The ultrasonic cardiac output monitor 1A system (USCOM Ltd., Sydney, Australia) is a non-invasive Doppler stroke volume (SV) technique derived from echocardiography.In the USCOM + ultrafiltration group, cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output. The monitored parameters include, SV index (SVI), SV variation (SVV), cardiac output (CO), cardiac index (CI), inotropy (INO), systemic vascular resistance index (SVRI), systemic vascular resistance (SVR), flow time corrected (FTC) and velocity time integral (VTI) . | Device | USCOM + ultrafiltration group-experimental group |
Primary outcome
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
Time frame: One week
SVV, systemic vascular variation, unit of mesure:%
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
Time frame: One week
SVI, systemic vascular index , unit of mesure: ml/m2
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
Time frame: One week
CI, cardiac index, unit of measure: l/min/m2.
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
Time frame: One week
INO, inotropy, unit of measure: w/m2
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
Time frame: One week
CO, cardiac output, unit of measure: l/min.
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
Time frame: One week
SVRI, systemic vascular resistance index, unit of measure: ds cm-5m2.
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
Time frame: One week
SVR, systemic vascular resistance index, unit of measure: ds cm-5.
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
Time frame: One week
FTC, flow time corrected, unit of measure: ms.
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.
Time frame: One week
VTI, velocity time integral, unit of measure: cm.
Brain natriuretic peptide
Time frame: One week
BNP, Brain natriuretic peptide, unit of measure: pg/ml.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 40475748Li Y, Chen J, Bian J, Chen F, Wan Q, Yuan F. Cardiac Indices Parameters on the Ultrasonic Cardiac Output Monitor as Potential Indicators to Predict the Ultrafiltration Endpoint Success in Acute Heart Failure Treatment. Rev Cardiovasc Med. 2025 May 22;26(5):27100. doi: 10.31083/RCM27100. eCollection 2025 May.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The ultrasonic cardiac output monitor 1A system (USCOM Ltd., Sydney, Australia) is a non-invasive Doppler stroke volume (SV) technique derived from echocardiography. in people with Acute Heart Failure, run by Shanghai Tong Ren Hospital at 1 site in China.
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 10 inclusion and 13 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: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output. (time frame: One week). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06533124, which also lists 1 linked publication.
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 1 Aug 2024.