Transesophageal EchocardiographyPhase 2/3NCT05768230
Using TEE to Evaluate the Effect of Levosimendan on Patients With ARDS Associated With RVD During MV
A Phase 2/3 study testing levosimendan and 5% glucose injection in people with Transesophageal Echocardiography and Acute Respiratory Distress Syndrome, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Acute respiratory distress syndrome (ARDS) is often complicated by right ventricular dysfunction (RVD), Acute cor pulmonale is the most serious form of ARDS complicated with RVD.Levosimendan is indicated for short-term treatment of acute decompensated heart failure that is not responding well to conventional therapy… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Transesophageal Echocardiography, Acute Respiratory Distress Syndrome, Right Ventricular Dysfunction
- What is being tested?
- levosimendan and 5% glucose injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2023to 1 Dec 2025
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who agree to participate in this clinical trial and sign informed consent
- Age 18-80 years old, gender unlimited
- Patients with ARDS(According to the diagnostic criteria of ARDS in Berlin 2012) requiring mechanical ventilation; Acute right ventricular dysfunction due to ARDS
Who cannot join
- Pregnant or lactating women;
- Chronic cardiac insufficiency, pulmonary hypertension and/or right ventricular enlargement caused by chronic cardiopulmonary disease, cardiogenic shock or after major cardiac surgery before ARDS;
- right ventricular myocardial infarction;
- Uncorrected hypotension, hypoxemia and hypercapnia, or acid-base balance disturbance
- Mechanical ventilation driving pressure >=18cmH2O before randomization
- Rapid arrhythmia;
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- pericardial tamponade;
- Pulmonary embolism;
- severe renal insufficiency;
- severe liver insufficiency;
- Failure to sign informed consent;
- known allergy to the test drug and control drug;
- Patients who have participated in other clinical trials within 30 days
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Yongran WU, master, 18627004016 ext. 027-85351607, 974528836@qq.com
About this study
Official title: Using Transesophageal Echocardiography to Evaluate the Effect of Levosimendan on Patients With Acute Respiratory Distress Syndrome Associated With Right Ventricular Dysfunction During Mechanical Ventilation
Acute respiratory distress syndrome (ARDS) is often complicated by right ventricular dysfunction (RVD), Acute cor pulmonale is the most serious form of ARDS complicated with RVD.Levosimendan is indicated for short-term treatment of acute decompensated heart failure that is not responding well to conventional therapy and requires increased myocardial contractile force.In 2016, the European Society of Cardiology issued recommendations for the management of acute right heart failure, stating that levosimendan can improve right ventriculo-pulmonary artery coupling by both increasing right heart contractility and reducing pulmonary vascular resistance.However, the clinical application of levosimendan in the treatment of ARDS right heart dysfunction is insufficient.Therefore, this study intends to use transesophageal ultrasound to evaluate right ventricular function, reduce the limitation of poor right ventricular window in transthoracic echocardiography, and conduct a multi-center randomized controlled study to further explore the effects of levosimendan on right ventricular function in ARDS patients, such as tricuspid ring systolic displacement (TAPSE) and tricuspid ring systolic displacement velocity (S '). Effects of right ventricular area change fraction (RV FAC), right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA), pulmonary circulation resistance (PVR), hemodynamics and mortality.
Read the detailed description
Acute respiratory distress syndrome (ARDS) is often complicated by right ventricular dysfunction (RVD),the incidence can be as high as 64%, Acute cor pulmonale is the most serious form of ARDS complicated with RVD. The prognosis of ARDS patients with RVD is worse and the risk of death would be significantly increased.Currently, there are very limited clinical drug treatment options for RVD.Levosimendan is indicated for short-term treatment of acute decompensated heart failure that is not responding well to conventional therapy and requires increased myocardial contractile force.In 2016, the European Society of Cardiology issued recommendations for the management of acute right heart failure, stating that levosimendan can improve right ventriculo-pulmonary artery coupling by both increasing right heart contractility and reducing pulmonary vascular resistance. Levosimendan is therefore recommended to be given priority over dobutamine in the treatment of acute right heart failure.At present, there are also relevant clinical studies reporting that levosimendan can be used in acute right heart failure caused by different causes, including a single center randomized controlled study reporting that levosimendan can do work in the right ventricle of patients with sepsis ARDS, and has beneficial hemodynamic effects.However, the clinical application of levosimendan in the treatment of ARDS right heart dysfunction is insufficient.Therefore, this study intends to use transesophageal ultrasound to evaluate right ventricular function, reduce the limitation of poor right ventricular window in transthoracic echocardiography, and conduct a multi-center randomized controlled study to further explore the effects of levosimendan on right ventricular function in ARDS patients, such as tricuspid ring systolic displacement (TAPSE) and tricuspid ring systolic displacement velocity (S '). Effects of right ventricular area change fraction (RV FAC), right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA), pulmonary circulation resistance (PVR), RV-PA coupling, hemodynamics and mortality.
- Conditions
- Transesophageal Echocardiography, Acute Respiratory Distress Syndrome, Right Ventricular Dysfunction
- Being tested
- levosimendan, 5% glucose injection
- Medical subject headings
- Respiratory Distress Syndrome, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levosimendanDrug
Levosimendan 12.5mg was injected intravenously in a 5% glucose injection 50ml configuration at a rate of 2ml/h for 24 hours.The injection was performed at a constant rate of 2ml/h. If there was no significant hypotension or tachycardia, the injection was completed within 24h
5% glucose injectionDrug
5% glucose injection 50ml configuration at a rate of 2ml/h for 24 hours.The injection was performed at a constant rate of 2ml/h. If there was no significant hypotension or tachycardia, the injection was completed within 24h
| Study group | Role | What they receive |
|---|---|---|
| treatment group A | Experimental | intravenously injected levosimendan 12.5mg with 5% glucose injection 50ml configuration at 2ml/h for 24h Receives: Drug: levosimendan |
| treatment group B | Placebo comparator | treatment group B: control group with 5% glucose injection 2ml/h for 24h Receives: Drug: 5% glucose injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of right ventricular dysfunction occurrence within 48 hours after randomization.
Right ventricular dysfunction(RVD) is diagnosed when the results of an echocardiogram show one of the following, including: tricuspid annular plane systolic excursion(TAPSE)<16 mm, right ventricular fractional area change(RV FAC)<35% or systolic velocity of the lateral tricuspid valve annulus( RV S')<10 cm/s.
Measured: From the time point of enrollment to 48 hours after enrollment
Secondary outcomes (14)
Right ventricular area fractional change (RV FAC) 48 hours after randomization
Right ventricular area fractional change (RV FAC)is a simple and repeatable ultrasound method for evaluating RV function. Methods: The RV end-diastolic area (RVEDA) and RV end-systolic area (RVESA) were measured on the apical four-chamber section by two-dimensional ultrasound. RV FAC=(RVEDA- RVESA)/RVEDA*100%.
Measured: at the time of 48 hours after enrollment
tricuspid annular plane systolic excursion(TAPSE) 48 hours after randomization
TAPSE is one of the most effective ultrasound methods for evaluating right ventricular function.Measurement method: TAPSE was measured on the four-chamber section of the apex of the heart by M-mode ultrasound. the sampling line was placed at the side wall of the tricuspid valve ring, parallel to the free wall of the right ventricle as far as possible, and the displacement of the tricuspid valve ring was measured from the end of diastole to the end of systole.
Measured: at the time of 48 hours after enrollment
Tricuspid annular systolic S' velocity (TS')
TS' is an objective and accurate ultrasound technique for evaluating right ventricular function.Measurement method:The sample volume was applied to the free wall of the RV and the peak velocity of tricuspid annulus motion was measured in the four-chamber section of the apex by tissue doppler imaging (TDI)
Measured: at the time of 48 hours after enrollment
Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)
RVEDA/LVEDA a simple and repeatable ultrasound method for evaluating dynamics changes of RV function.Methods: The RV end-diastolic area (RVEDA) and left ventricular(LV) end-systolic area (LVEDA) were measured on the apical four-chamber section by two-dimensional ultrasound
Measured: at the time of 48 hours after enrollment
Pulmonary circulatory resistance (PVR)
Increased PVR can lead to deterioration of RV function.Pulse Doppler imaging (PWD) was used to obtain the pulmonary artery flow spectrum from the pulmonic valve on the short axial section of the parasternal great vessels.
Measured: at the time of 48 hours after enrollment
Sequential Organ Failure Assessment score
The higher the Sequential Organ Failure Assessment(SOFA) score, the higher the disease risk factor and the higher the mortality rate(The highest score is 24, while the lowest score is 0).
Measured: at the time of 48 hours after enrollment
cardiac index(CI) patients
CI is an important parameter to reflect the cardiac function of
Measured: at the time of 48 hours after enrollment
Central venous oxygen saturation(ScvO2)
The patient's blood was collected through a central venous catheter for blood gas analysis to calculate SCVO2 to indicate tissue perfusion
Measured: at the time of 48 hours after enrollment
systemic vascular resistance(SVR)
Peripheral vascular resistance is an important indicator of hemodynamics. It is not only a parameter reflecting cardiac afterload, but also a quantitative indicator reflecting the degree of patency of cerebrovascular microcirculation.
Measured: at the time of 48 hours after enrollment
Mean arterial pressure (MAP)
MAP represents peripheral organ perfusion pressure.
Measured: at the time of 48 hours after enrollment
Central venous pressure(CVP)
CVP is the pressure of the upper and lower vena cava entering the right atrium, measured by the upper and lower vena cava or the internal tube of the right atrium, which reflects the pressure of the right atrium, and is one of the main indicators for clinical observation of hemodynamics
Measured: at the time of 48 hours after enrollment
systemic vascular resistance index(SVRI)
SVRI=80*(MAP-CVP)/CI
Measured: at the time of 48 hours after enrollment
28-day mortality
28-day mortality after study entry
Measured: Day 28 after study entry
in-hospital mortality
Any death occurred during hospitalization(up to 90 days)
Measured: From the day patients admitted to hospital to the day death or discharge(up to 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start22 Mar 2023 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transesophageal EchocardiographyStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to treatment group A: intravenously injected levosimendan 12.5mg with 5% glucose injection 50ml configuration at 2ml/h for 24h, or treatment group B: control group with 5% glucose injection 2ml/h for 24h.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768230
- Sponsor's protocol ID
- ARVD20220810
- Status last verified
- Dec 2022
- First submitted
- 18 Feb 2023
- Last updated
- 14 Mar 2023
- 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 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Transesophageal Echocardiography to Evaluate the Effect of Levosimendan on Patients With Acute Respiratory Distress Syndrome Associated With Right Ventricular Dysfunction During Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05768230
- Acronym / sponsor ID
- ARVD20220810
- Conditions
- Transesophageal Echocardiography, Acute Respiratory Distress Syndrome, Right Ventricular Dysfunction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 22 Mar 2023 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 14 Mar 2023 (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.
Acute respiratory distress syndrome (ARDS) is often complicated by right ventricular dysfunction (RVD), Acute cor pulmonale is the most serious form of ARDS complicated with RVD.Levosimendan is indicated for short-term treatment of acute decompensated heart failure that is not responding well to conventional therapy and requires increased myocardial contractile force.In 2016, the European Society of Cardiology issued recommendations for the management of acute right heart failure, stating that levosimendan can improve right ventriculo-pulmonary artery coupling by both increasing right heart contractility and reducing pulmonary vascular resistance.However, the clinical application of levosimendan in the treatment of ARDS right heart dysfunction is insufficient.Therefore, this study intends to use transesophageal ultrasound to evaluate right ventricular function, reduce the limitation of poor right ventricular window in transthoracic echocardiography, and conduct a multi-center randomized controlled study to further explore the effects of levosimendan on right ventricular function in ARDS patients, such as tricuspid ring systolic displacement (TAPSE) and tricuspid ring systolic displacement velocity (S '). Effects of right ventricular area change fraction (RV FAC), right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA), pulmonary circulation resistance (PVR), hemodynamics and mortality.
Detailed description
Acute respiratory distress syndrome (ARDS) is often complicated by right ventricular dysfunction (RVD),the incidence can be as high as 64%, Acute cor pulmonale is the most serious form of ARDS complicated with RVD. The prognosis of ARDS patients with RVD is worse and the risk of death would be significantly increased.Currently, there are very limited clinical drug treatment options for RVD.Levosimendan is indicated for short-term treatment of acute decompensated heart failure that is not responding well to conventional therapy and requires increased myocardial contractile force.In 2016, the European Society of Cardiology issued recommendations for the management of acute right heart failure, stating that levosimendan can improve right ventriculo-pulmonary artery coupling by both increasing right heart contractility and reducing pulmonary vascular resistance. Levosimendan is therefore recommended to be given priority over dobutamine in the treatment of acute right heart failure.At present, there are also relevant clinical studies reporting that levosimendan can be used in acute right heart failure caused by different causes, including a single center randomized controlled study reporting that levosimendan can do work in the right ventricle of patients with sepsis ARDS, and has beneficial hemodynamic effects.However, the clinical application of levosimendan in the treatment of ARDS right heart dysfunction is insufficient.Therefore, this study intends to use transesophageal ultrasound to evaluate right ventricular function, reduce the limitation of poor right ventricular window in transthoracic echocardiography, and conduct a multi-center randomized controlled study to further explore the effects of levosimendan on right ventricular function in ARDS patients, such as tricuspid ring systolic displacement (TAPSE) and tricuspid ring systolic displacement velocity (S '). Effects of right ventricular area change fraction (RV FAC), right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA), pulmonary circulation resistance (PVR), RV-PA coupling, hemodynamics and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to treatment group A: intravenously injected levosimendan 12.5mg with 5% glucose injection 50ml configuration at 2ml/h for 24h, or treatment group B: control group with 5% glucose injection 2ml/h for 24h.
| Arm | Type | Receives |
|---|---|---|
| treatment group A | Experimental | Drug: levosimendanintravenously injected levosimendan 12.5mg with 5% glucose injection 50ml configuration at 2ml/h for 24h |
| treatment group B | Placebo comparator | Drug: 5% glucose injectiontreatment group B: control group with 5% glucose injection 2ml/h for 24h |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who agree to participate in this clinical trial and sign informed consent
- Age 18-80 years old, gender unlimited
- Patients with ARDS(According to the diagnostic criteria of ARDS in Berlin 2012) requiring mechanical ventilation; Acute right ventricular dysfunction due to ARDS
Key exclusion criteria (13 listed)
- Pregnant or lactating women;
- Chronic cardiac insufficiency, pulmonary hypertension and/or right ventricular enlargement caused by chronic cardiopulmonary disease, cardiogenic shock or after major cardiac surgery before ARDS;
- right ventricular myocardial infarction;
- Uncorrected hypotension, hypoxemia and hypercapnia, or acid-base balance disturbance
- Mechanical ventilation driving pressure >=18cmH2O before randomization
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 |
|---|---|---|
| levosimendanLevosimendan 12.5mg was injected intravenously in a 5% glucose injection 50ml configuration at a rate of 2ml/h for 24 hours.The injection was performed at a constant rate of 2ml/h. If there was no significant hypotension or tachycardia, the injection was completed within 24h | Drug | treatment group A |
| 5% glucose injection5% glucose injection 50ml configuration at a rate of 2ml/h for 24 hours.The injection was performed at a constant rate of 2ml/h. If there was no significant hypotension or tachycardia, the injection was completed within 24h | Drug | treatment group B |
Primary outcome
The rate of right ventricular dysfunction occurrence within 48 hours after randomization.
Time frame: From the time point of enrollment to 48 hours after enrollment
Right ventricular dysfunction(RVD) is diagnosed when the results of an echocardiogram show one of the following, including: tricuspid annular plane systolic excursion(TAPSE)<16 mm, right ventricular fractional area change(RV FAC)<35% or systolic velocity of the lateral tricuspid valve annulus( RV S')<10 cm/s.
14 secondary outcomes
Right ventricular area fractional change (RV FAC) 48 hours after randomization
Time frame: at the time of 48 hours after enrollment
tricuspid annular plane systolic excursion(TAPSE) 48 hours after randomization
Time frame: at the time of 48 hours after enrollment
Tricuspid annular systolic S' velocity (TS')
Time frame: at the time of 48 hours after enrollment
Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)
Time frame: at the time of 48 hours after enrollment
Pulmonary circulatory resistance (PVR)
Time frame: at the time of 48 hours after enrollment
Sequential Organ Failure Assessment score
Time frame: at the time of 48 hours after enrollment
cardiac index(CI) patients
Time frame: at the time of 48 hours after enrollment
Central venous oxygen saturation(ScvO2)
Time frame: at the time of 48 hours after enrollment
systemic vascular resistance(SVR)
Time frame: at the time of 48 hours after enrollment
Mean arterial pressure (MAP)
Time frame: at the time of 48 hours after enrollment
Central venous pressure(CVP)
Time frame: at the time of 48 hours after enrollment
systemic vascular resistance index(SVRI)
Time frame: at the time of 48 hours after enrollment
28-day mortality
Time frame: Day 28 after study entry
in-hospital mortality
Time frame: From the day patients admitted to hospital to the day death or discharge(up to 90 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing levosimendan and 5% glucose injection in people with Transesophageal Echocardiography and Acute Respiratory Distress Syndrome, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 3 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: status not confirmed, as of the sponsor's last update on 14 Mar 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yongran Wu, MD (027-85351606, 974528836@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of right ventricular dysfunction occurrence within 48 hours after randomization. (time frame: From the time point of enrollment to 48 hours after enrollment). 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 14 Mar 2023.