Ventricular Dysfunction, RightREA-3D-VDNCT04222764
Evaluation of the Right Ventricular Systolic Function Using Real-time Three-dimensional Echocardiography in Intensive Care Unit Patients
An observational study of Ventricular Dysfunction, Right and Lung Diseases, run by University Hospital, Limoges at 2 sites in France.
Trial summary
Right ventricular failure (RVF) is an independent factor of mortality for many pulmonary diseases. Currently, RVF is defined as the incapacity of the RV to maintain the flow without dilating to use the Frank-Starling law (i.e., increase of the ejection volume associated to an increase of the preload). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Dysfunction, Right, Lung Diseases, Intensive Care Units
- What is being tested?
- Real-time three-dimensional echocardiography
- How many people
- 341 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Apr 2020to 28 Sep 2023
- Phase
- Observational
- 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
Study population: high risk right ventricular Failure intensive care patients
Who may be able to join
- Adult patients (≥ 18 years old) hospitalized in the ICU and requiring echocardiography for any reason
- With a disease at risk of being associated with RVF:
- ARDS (Berlin definition)
- Sepsis or septic shock (Sepsis-3 definition)
- Pulmonary embolism
- RV infarction
- Affiliated to Social Security
- Consent of the patient and/or his authorized representative to participate in the study.
Who cannot join
- History of congenital cardiac disease
- Patient under legal protection
- Under any method of oxygen support or extracorporeal circulatory support (veno-venous extracorporeal membrane oxygenation, extracorporeal Life support...)
- Non sinusal rhythm
- Documented preexisting right cardiac disease
- Quality of echocardiographic images incompatible with 3D assessment.
Trial locations and contacts
2 sites in 1 country.
About this study
Right ventricular failure (RVF) is an independent factor of mortality for many pulmonary diseases. Currently, RVF is defined as the incapacity of the RV to maintain the flow without dilating to use the Frank-Starling law (i.e., increase of the ejection volume associated to an increase of the preload). RVF is associated to RV systolic dysfunction which is conventionally defined as a decrease of the RV ejection fraction (RVEF) < 45%.
In the intensive care unit (ICU), acute RVF is mainly due to the acute respiratory distress syndrome (ARDS), sepsis or septic shock, and less often to severe pulmonary embolism or RV infarction.
Read more
The anatomical complexity of the RV precludes any geometrical assumption to estimate its volume, hence its ejection fraction (EF) using two-dimensional (2D) echocardiography. For this reason, the evaluation of RV systolic function is currently based on parameters used as surrogates of RVEF: fraction area change in 2D-mode, tricuspid annular plane systolic excursion (TAPSE) in M-mode, and maximal velocity of the systolic S' wave using tissue Doppler imaging.
Real-time three-dimensional (3D) echocardiography now enables accurate on-line measurement of RV volume and provides at the bedside the non-invasive assessment of RVEF. 3D transthoracic echocardiography (TTE) has been validated to measure RV volume and RVEF compared to MRI which is the gold standard. However, 3D transesophageal echocardiography (TEE) has not yet been validated in this specific clinical setting, while 2D TEE is frequently used in ICU in ventilated and sedated patients. Accordingly, the diagnostic ability of 3D echocardiography to quantify RV systolic function in ICU patients with RVF of any origin is currently unknown.
- Being tested
- Real-time three-dimensional echocardiography
- Keywords
- Right ventricular failure, Lung Diseases, Intensive Care Units
- Medical subject headings
- Ventricular Dysfunction, Right, Lung Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time three-dimensional echocardiographyDiagnostic test
The initial hemodynamic assessment and monitoring using echocardiography will be performed within 12h following ICU admission. TTE will be performed systematically as first-line examination and TEE will be performed only on ventilated and sedated patients for whom additional information is required for their management, according to the standards of care of the participating centers. In that case, TEE will be performed immediately after TTE.
3D echocardiographic measurements will be performed after the examination by two independent intensivists expert in critical care echocardiography who will be blinded from the usual parameters of RV systolic functions; these parameters will be measured during the examination to guide the management of patients, according to the standard of care of the participating centers.
| Study group | Role | What they receive |
|---|---|---|
| Real-time three-dimensional echocardiography | Not described Receives: Diagnostic Test: Real-time three-dimensional echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic parameter
Agreement between the values of conventional echocardiographic parameters of RV systolic function and RVEF measured using TTE and considered as reference
Measured: through study completion, an average of 28 days
Secondary outcomes (10)
Threshold values of the conventional echocardiographic parameters identification
Threshold values of the conventional echocardiographic parameters to identify RV systolic dysfunction identified with RVEF measurement using 3D TTE (ROC curves: best sensitivity/specificity compromise)
Measured: through study completion, an average of 28 days
RV end-diastolic volume measurement
RV end-diastolic measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)
Measured: through study completion, an average of 28 days
RV end-systolic volume measurement
RV end-systolic volume measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)
Measured: through study completion, an average of 28 days
RVEF measurement
RVEF measured using 3D TEE and 3D TTE (comparability if maximal difference < 10%)
Measured: through study completion, an average of 28 days
RVEF measurement 3D
RVEF measured using 3D echocardiography (reference) and conventional echocardiographic parameters of RV systolic function in each disease responsible for RVF
Measured: through study completion, an average of 28 days
Conventional echocardiographic parameters of RV systolic function measurement 3D
Conventional echocardiographic parameters of RV systolic function measured using 3D echocardiography in each disease responsible for RVF
Measured: through study completion, an average of 28 days
Percentage of performed measurement
Percentage of performed measurements correlated to the theoretical number of possible measurements; intra and inter-observer reproducibility
Measured: through study completion, an average of 28 days
Diagnosis of acute cor pulmonale
Agreement between conventional echocardiography and 3D echocardiography for the diagnosis of acute cor pulmonale (most severe type of RVF) as defined by an acute RV dilatation (RV/Left Ventricular end-diastolic area ratio > 0.6 in the long-axis view of the heart) associated to a paradoxical septum in the short-axis view of the heart
Measured: through study completion, an average of 28 days
Number of deceased participant
ICU and hospital mortality
Measured: through study completion, an average of 28 days
longitudinal systolic distortion of the RV free wall (strain) measurement
Relation and agreement between longitudinal systolic distortion of the RV free wall (strain), RVEF, and conventional parameters of RV systolic function
Measured: through study completion, an average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start3 Apr 2020
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Dysfunction, RightStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222764
- Sponsor's protocol ID
- 87RI19_0035 (REA-3D-VD)
- Acronym
- REA-3D-VD
- Status last verified
- Jan 2024
- First submitted
- 7 Jan 2020
- Last updated
- 9 Jan 2024
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Right Ventricular Systolic Function Using Real-time Three-dimensional Echocardiography in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT04222764
- Acronym / sponsor ID
- REA-3D-VD / 87RI19_0035 (REA-3D-VD)
- Keywords
- Right ventricular failure, Lung Diseases, Intensive Care Units
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 10 Jan 2020 (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.
Right ventricular failure (RVF) is an independent factor of mortality for many pulmonary diseases. Currently, RVF is defined as the incapacity of the RV to maintain the flow without dilating to use the Frank-Starling law (i.e., increase of the ejection volume associated to an increase of the preload). RVF is associated to RV systolic dysfunction which is conventionally defined as a decrease of the RV ejection fraction (RVEF) < 45%.
In the intensive care unit (ICU), acute RVF is mainly due to the acute respiratory distress syndrome (ARDS), sepsis or septic shock, and less often to severe pulmonary embolism or RV infarction.
The anatomical complexity of the RV precludes any geometrical assumption to estimate its volume, hence its ejection fraction (EF) using two-dimensional (2D) echocardiography. For this reason, the evaluation of RV systolic function is currently based on parameters used as surrogates of RVEF: fraction area change in 2D-mode, tricuspid annular plane systolic excursion (TAPSE) in M-mode, and maximal velocity of the systolic S' wave using tissue Doppler imaging.
Real-time three-dimensional (3D) echocardiography now enables accurate on-line measurement of RV volume and provides at the bedside the non-invasive assessment of RVEF. 3D transthoracic echocardiography (TTE) has been validated to measure RV volume and RVEF compared to MRI which is the gold standard. However, 3D transesophageal echocardiography (TEE) has not yet been validated in this specific clinical setting, while 2D TEE is frequently used in ICU in ventilated and sedated patients. Accordingly, the diagnostic ability of 3D echocardiography to quantify RV systolic function in ICU patients with RVF of any origin is currently unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real-time three-dimensional echocardiography | – | Diagnostic Test: Real-time three-dimensional echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- high risk right ventricular Failure intensive care patients
Key inclusion criteria (8 listed)
- Adult patients (≥ 18 years old) hospitalized in the ICU and requiring echocardiography for any reason
- With a disease at risk of being associated with RVF:
- Affiliated to Social Security
- Consent of the patient and/or his authorized representative to participate in the study.
Key exclusion criteria (6 listed)
- History of congenital cardiac disease
- Patient under legal protection
- Under any method of oxygen support or extracorporeal circulatory support (veno-venous extracorporeal membrane oxygenation, extracorporeal Life support...)
- Non sinusal rhythm
- Documented preexisting right cardiac disease
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 |
|---|---|---|
| Real-time three-dimensional echocardiographyThe initial hemodynamic assessment and monitoring using echocardiography will be performed within 12h following ICU admission. TTE will be performed systematically as first-line examination and TEE will be performed only on ventilated and sedated patients for whom additional information is required for their management, according to the standards of care of the participating centers. In that case, TEE will be performed immediately after TTE. 3D echocardiographic measurements will be performed after the examination by two independent intensivists expert in critical care echocardiography who will be blinded from the usual parameters of RV systolic functions; these parameters will be measured during the examination to guide the management of patients, according to the standard of care of the participating centers. | Diagnostic test | Real-time three-dimensional echocardiography |
Primary outcome
Echocardiographic parameter
Time frame: through study completion, an average of 28 days
Agreement between the values of conventional echocardiographic parameters of RV systolic function and RVEF measured using TTE and considered as reference
10 secondary outcomes
Threshold values of the conventional echocardiographic parameters identification
Time frame: through study completion, an average of 28 days
RV end-diastolic volume measurement
Time frame: through study completion, an average of 28 days
RV end-systolic volume measurement
Time frame: through study completion, an average of 28 days
RVEF measurement
Time frame: through study completion, an average of 28 days
RVEF measurement 3D
Time frame: through study completion, an average of 28 days
Conventional echocardiographic parameters of RV systolic function measurement 3D
Time frame: through study completion, an average of 28 days
Percentage of performed measurement
Time frame: through study completion, an average of 28 days
Diagnosis of acute cor pulmonale
Time frame: through study completion, an average of 28 days
Number of deceased participant
Time frame: through study completion, an average of 28 days
longitudinal systolic distortion of the RV free wall (strain) measurement
Time frame: through study completion, an average of 28 days
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 9 Jan 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Dysfunction, Right and Lung Diseases, run by University Hospital, Limoges at 2 sites in France.
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 8 inclusion and 6 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 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Echocardiographic parameter (time frame: through study completion, an average of 28 days). 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 9 Jan 2024.