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

NCT06533124 | Completed DMC

• 1 other identifier: 2019-072-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. The primary endpoint was differences in the hemodynamics of patients receiving UF alone or UF+USCOM. A prediction model was established.

Conditions

Acute Heart Failure

Keywords

Ultrasonic cardiac output monitor (USCOM); Acute heart failure; Brain natriuretic peptide; Ultrafiltration; Echocardiography

Outcome Measures

Primary Outcomes (10)

• 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:%

  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

  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.

  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

  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.

  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.

  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.

  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.

  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.

  One week

• Brain natriuretic peptide

  BNP, Brain natriuretic peptide, unit of measure: pg/ml.

  One week

Study Arms (2)

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) .

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.

Interventions

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) .

USCOM + ultrafiltration group-experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Tong Ren Hospital: lead

Study Sites (1)

ShanghaiTongren Hospital

Shanghai, Shanghai Municipality, 200336, China

Location

Related Publications (1)

• 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.

  PMID: 40475748 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: January 5, 2022
• Primary Completion: July 5, 2023
• Study Completion: August 1, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

CN (1)