An observational study in Ventricular Dysfunction, Right, Lung Diseases and Intensive Care Units, sponsored by University Hospital, Limoges. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-09.
Sponsored by University Hospital, Limoges · Observational
Among 10 studies in Ventricular Dysfunction, Right with a site in France — 3 open to participants now, 3 under way, none of them phase 3. Ventricular Dysfunction, Right · France.
Among the 10 studies in Ventricular Dysfunction, Right with a site in France, this one is the only one that started in 2020, is one of 5 observational ones, and was the 5th registered.
90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.
This study's enrollment of 341 is above the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.
Browse Ventricular Dysfunction, Right studies →3 of the 10 studies in Ventricular Dysfunction, Right with a site in France are open now, in 1 country. Each count lists the studies.
Of the 17 Ventricular Dysfunction, Right studies recruiting now, 15 (88%) set no upper age limit and 1 (6%) stop at 75 or younger; 1 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2020.
Median enrollment 72 across the 5 interventional studies, 100 across the 5 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
None of the 10 has an industry lead sponsor. The 8 most frequent:
University Hospital, Limoges is the lead sponsor of 264 studies on the registry; 38 are open to participants now.
University Hospital, Limoges has 1 study filed under Ventricular Dysfunction, Right — fewer than ten, so there is no comparison to draw.
1 of the studies in Ventricular Dysfunction, Right with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06166329University Hospital, RouenInterest of the Chair Lift Test in the Prognostic Evaluation of Pulmonary Embolism: a Single-center Open Prospective Study | 2027-02 |
Among the 10 studies in Ventricular Dysfunction, Right with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
high risk right ventricular Failure intensive care patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
With a disease at risk of being associated with RVF:
Exclusion Criteria:
Diagnostic Test: Real-time three-dimensional echocardiography
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.
Echocardiographic parameter
Agreement between the values of conventional echocardiographic parameters of RV systolic function and RVEF measured using TTE and considered as reference
Time frame: through study completion, an average of 28 days
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)
Time frame: 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%)
Time frame: 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%)
Time frame: through study completion, an average of 28 days
RVEF measurement
RVEF measured using 3D TEE and 3D TTE (comparability if maximal difference \< 10%)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 28 days
Number of deceased participant
ICU and hospital mortality
Time frame: 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
Time frame: through study completion, an average of 28 days
Ran from Apr 2020 to primary completion in Sep 2023, 41 months.
Of 25 observational studies under Ventricular Dysfunction, Right, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 26. This study's 41 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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