Comparison Between a Robotic Tele-echo-cardiography Technique and a Standard Echocardiography in the Management of Heart Failure in the Guadeloupe Archipelago Between the University Hospital of Guadeloupe and the Marie-Galante Hospital (TER de blueS)

December 3, 2025 updated by: Centre Hospitalier Universitaire de la Guadeloupe
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Guadeloupe
      • Grand-Bourg, Guadeloupe, 97122
        • Recruiting
        • Centre Hospitalier Sainte-Marie de Marie-Galante
        • Contact:
        • Principal Investigator:
          • Mona Hedreville, MD
      • Petit-Bourg, Guadeloupe, 97170
      • Petit-Canal, Guadeloupe, 97131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years

    • Free, informed and written consent signed by the participant and the investigator
    • Person affiliated or benefiting from a social security scheme.
    • Patient meeting at least one of the following criteria:
  • Systematic cardiovascular check-up or asymptomatic patient with cardiovascular risk factor (hypertension, diabetes, obesity, tobacco, alcohol)

  • Clinical suspicion of heart disease and/or chronic heart failure with stability of at least one week.

    • Family history of heart disease and/or sudden death

Exclusion Criteria:

  • Patient requiring urgent cardiological management with transfer to the University Hospital

    • Acute unstable heart failure, admission to CH Marie-Galante less than 5 days (less than one week)
    • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: in situ ultrasound (EIS) performed first
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)
In situ echocardiography (EIS) will be performed by the cardiologist present in Marie-Galante Hospital.
Diagnostic test: two-dimensional remote echocardiography (TER)
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.
Experimental: Arm B: two-dimensional remote echocardiography (TER) performed first
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)
In situ echocardiography (EIS) will be performed by the cardiologist present in Marie-Galante Hospital.
Diagnostic test: two-dimensional remote echocardiography (TER)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement of Left Ventricular Ejection Fraction (LVEF) Measurements Between Echocardiography Techniques
Time Frame: Measured at the second visit (V2) at 2 weeks.
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.
Measured at the second visit (V2) at 2 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement Between Echocardiography Techniques for Diagnosis of Cardiac Anomalies
Time Frame: Measured at the second visit (V2) at 2 weeks.
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.
Measured at the second visit (V2) at 2 weeks.
Dilated Cardiomyopathy Assessment
Time Frame: Measured at Visit 2 (V2), 2 weeks after baseline.
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.
Measured at Visit 2 (V2), 2 weeks after baseline.
Quantitative Echocardiographic Measures
Time Frame: Measured at the second visit (V2) at 2 weeks.

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.
Measured at the second visit (V2) at 2 weeks.
Hypertrophic Cardiomyopathy Assessment
Time Frame: Measured at Visit 2 (V2), 2 weeks after baseline.
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.
Measured at Visit 2 (V2), 2 weeks after baseline.
Valvulopathy Assessment
Time Frame: Measured at V2 (2 weeks)
Presence or absence of aortic or mitral stenosis and regurgitation will be reported as number of participants with valvulopathies for each technique.
Measured at V2 (2 weeks)
Systolic Pulmonary Arterial Pressure (PAP)
Time Frame: Measured at V2 (2 weeks)
Systolic PAP will be measured from tricuspid regurgitation or estimated indirectly from systolic pulmonary ejection flow. Reported in mmHg.
Measured at V2 (2 weeks)
Left Ventricular Filling Pressure
Time Frame: Measured at V2 (2 weeks)
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).
Measured at V2 (2 weeks)
Duration of Echocardiography
Time Frame: Measured at the second visit (V2) at 2 weeks.
Total duration of each echocardiography session will be recorded in minutes for both techniques.
Measured at the second visit (V2) at 2 weeks.
Patient Satisfaction
Time Frame: Measured at the second visit (V2) at 2 weeks.

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.
Measured at the second visit (V2) at 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Collaborators

GIRCI SOHO

Investigators

  • Study Chair: Mona Hedreville, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2025

Primary Completion (Estimated)

September 8, 2026

Study Completion (Estimated)

September 8, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAP_RI2_2019/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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