An interventional study of in situ echocardiography (EIS) and two-dimensional remote echocardiography (TER) in Heart Failure, Remote Consultation, Teleconsultation and Echocardiography, Doppler, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Recruiting at 3 sites in Guadeloupe. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Not applicable, Interventional, and Diagnostic
The TERdeblue-S study is a feasibility study of robotic remote echocardiography, not only in terms of technology but also in terms of its integration into a telemedicine system to improve access to the heart failure management system in the Guadeloupe archipelago. The main objective of this study is to study the agreement of the measurement of the left ventricular ejection fraction (FejVG) between in situ echocardiography (EIS) and two-dimensional remote echocardiography (TER) (distance and volumes).
Considered as the new global epidemic of the 21st century, heart failure (HF) is a major public health issue. In 2010, the Guadeloupe region already had the highest rate of heart failure deaths in all French departments, furthermore cardiac decompensation of chronic heart failure is the first cardiovascular pathology to be managed in emergency medicine and the first cardiovascular cause of hospitalization. Marie-Galante is an island in the Guadeloupe archipelago, 36% of whose hospital stays are covered by the University Hospital Currently, access to specialized care in Marie-Galante, particularly cardiological care, is very limited with one to two monthly consultations by a specialist cardiologist accessible to a population . Rather, remote echocardiography has been the subject of experimental studies but has not yet been proposed as part of an optimization of the management of a specific cardiovascular disease at separate sites. This is a prospective multicentre study (two cardiologists in private practice of Guadeloupe and one at the Marie-Galante Hospital) interventional cross-over study in which the left ventricular ejection fraction (LVEF) will be the main judgement criterion. Patients will be randomized to determine the order of implementation of the techniques (echocardiography and then teleecardiography or the reverse). In addition, in order to take into account the operator effect, each of the 2 cardiologists will move alternately either for remote echocardiography or to Marie-Galante for in situ echocardiography.
The visit (V1) takes place at Marie-Galante's CH, as soon as possible after inclusion by the generalist practicionner or the cardiologist (V0) and is carried out by the state-registered nurse with a blood sample (biological check-up and biological collection) and ECG Holter place over 24 hours.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 50 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.
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Age ≥18 years
Clinical suspicion of heart disease and/or chronic heart failure with stability of at least one week.
Exclusion Criteria:
Patient requiring urgent cardiological management with transfer to the University Hospital
The in situ ultrasound (EIS) is performed first. Cardiologist A performs the imaging examination and then leaves the room. The Research Nurse installs the probe and then cardiologist B, positioned on the expert site in Guadeloupe, carries out the examination of robotic tele-echo-cardiography (TER). Cardiologist B communicates via videoconferencing with the patient and the Research Nurse.
Diagnostic Test: in situ echocardiography (EIS) · Diagnostic Test: two-dimensional remote echocardiography (TER)
The TER is carried out first. The probe is installed by the REsearch Nurse, cardiologist B positioned on the expert site of Guadeloupê carries out the TER examination. Cardiologist B communicates via videoconferencing with the patient and the remote assistant EDI. Then, once the examination is completed, cardiologist A performs the HIA.
Diagnostic Test: in situ echocardiography (EIS) · Diagnostic Test: two-dimensional remote echocardiography (TER)
In situ echocardiography (EIS) will be performed by the cardiologist present in Marie-Galante Hospital.
Remote echocardiography is performed by a cardiologist from a private practice in Guadeloupe, with a research nurse present at the patient's side at Marie-Galante Hospital.
Agreement of Left Ventricular Ejection Fraction (LVEF) Measurements Between Echocardiography Techniques
The main outcome measure is the agreement of left ventricular ejection fraction (LVEF) measurements between two echocardiography techniques. Agreement will be quantified using the intraclass correlation coefficient (ICC) and supplemented by Bland-Altman plots to visualize differences between methods.
Time frame: Measured at the second visit (V2) at 2 weeks.
Agreement Between Echocardiography Techniques for Diagnosis of Cardiac Anomalies
Agreement between two echocardiography techniques for diagnosing cardiac anomalies (dilated cardiomyopathy, hypertrophic cardiomyopathy, and valvulopathies) will be evaluated using the Kappa coefficient. Sensitivity and specificity of each technique for each anomaly will also be reported.
Time frame: Measured at the second visit (V2) at 2 weeks.
Dilated Cardiomyopathy Assessment
Presence or absence of dilated cardiomyopathy will be defined according to left ventricular telediastolic diameter and reported as number of participants with dilated cardiomyopathy for each technique.
Time frame: Measured at Visit 2 (V2), 2 weeks after baseline.
Quantitative Echocardiographic Measures
Agreement between the two echocardiography techniques will be assessed using the intraclass correlation coefficient (ICC), paired Student's t-test, and Bland-Altman plots for the following measures: Diastolic function - mitral Doppler inflow/outflow (I/O) ratio and tissue Doppler I/O ratio; Aortic flow - measured from subaortic velocity-time integral (ITV); Systolic pulmonary arterial pressure - derived from tricuspid insufficiency using the Bernoulli formula; Right ventricular systolic function - assessed by TAPSE.
Time frame: Measured at the second visit (V2) at 2 weeks.
Hypertrophic Cardiomyopathy Assessment
Presence or absence of hypertrophic cardiomyopathy will be defined based on septal and posterior wall thickness and reported as number of participants with hypertrophic cardiomyopathy for each technique.
Time frame: Measured at Visit 2 (V2), 2 weeks after baseline.
Valvulopathy Assessment
Presence or absence of aortic or mitral stenosis and regurgitation will be reported as number of participants with valvulopathies for each technique.
Time frame: Measured at V2 (2 weeks)
Systolic Pulmonary Arterial Pressure (PAP)
Systolic PAP will be measured from tricuspid regurgitation or estimated indirectly from systolic pulmonary ejection flow. Reported in mmHg.
Time frame: Measured at V2 (2 weeks)
Left Ventricular Filling Pressure
Changes in left ventricular (LV) filling pressures will be assessed using the E/e' ratio (mitral Doppler flow / tissue Doppler flow at the mitral annulus).
Time frame: Measured at V2 (2 weeks)
Duration of Echocardiography
Total duration of each echocardiography session will be recorded in minutes for both techniques.
Time frame: Measured at the second visit (V2) at 2 weeks.
Patient Satisfaction
Patient satisfaction with the tele-echocardiography procedure will be assessed using an adapted TeleHealth Satisfaction Questionnaire (TSQ). Each item is scored on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied), resulting in a total score range of 0 to 100 after standardization, where higher scores indicate greater satisfaction. All assessments will be conducted at the tele-echocardiography session by a blinded evaluator or self-reported by the patient.
Time frame: Measured at the second visit (V2) at 2 weeks.
Plan to share: No
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Centre Hospitalier Universitaire de la Guadeloupe