Heart FailureTER de blueSNCT07265986
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
A study testing in situ echocardiography (EIS) and two-dimensional remote echocardiography (TER) in people with Heart Failure and Remote Consultation, Teleconsultation, run by Centre Hospitalier Universitaire de la Guadeloupe at 3 sites in Guadeloupe.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Remote Consultation, Teleconsultation, Echocardiography, Doppler
- What is being tested?
- in situ echocardiography (EIS) and two-dimensional remote echocardiography (TER)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesGuadeloupe
- Study dates
- 30 Nov 2025to 8 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Guadeloupe3 sites, 3 recruiting
- Recruiting
Centre Hospitalier Sainte-Marie de Marie-Galante
Grand-Bourg, 97122
Mélanie petapermal, +590590934667, melanie.petapermal@chu-guadeloupe.fr
Mona Hedreville, MD
- Not yet recruiting
Centre de Cardiologie Zac Colin
Petit-Bourg, 97170
ségo Hedreville, MD, +590590386355, hedrevillesego.cabinet@orange.fr
- Not yet recruiting
Cabinet de cardiologie TONCOEURTONKA
Petit-Canal, 97131
mona Hedreville, MD, +590590503009, dr.monahedreville@toncoeurtonka.com
About this study
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).
Read the 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.
- Being tested
- in situ echocardiography (EIS), two-dimensional remote echocardiography (TER)
- Keywords
- heart failure, remote echocardiography doppler, telemedicine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in situ echocardiography (EIS)Diagnostic test
In situ echocardiography (EIS) will be performed by the cardiologist present in Marie-Galante Hospital.
two-dimensional remote echocardiography (TER)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: in situ ultrasound (EIS) performed first | Experimental | 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. Receives: Diagnostic Test: in situ echocardiography (EIS); Diagnostic Test: two-dimensional remote echocardiography (TER) |
| Arm B: two-dimensional remote echocardiography (TER) performed first | Experimental | 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. Receives: Diagnostic Test: in situ echocardiography (EIS); Diagnostic Test: two-dimensional remote echocardiography (TER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measured at the second visit (V2) at 2 weeks.
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Measured at V2 (2 weeks)
Duration of Echocardiography
Total duration of each echocardiography session will be recorded in minutes for both techniques.
Measured: 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.
Measured: Measured at the second visit (V2) at 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start30 Nov 2025
- Primary completion8 Sep 2026 (estimated)
- Study completion8 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a prospective multicentre study (one cardiologist in a private practice in Guadeloupe and one at the Marie-Galante Hospital) interventional cross-over study in which the measurements obtained successively by tele-echo-cardiography and standard echocardiography will be compared. Among the set of parameters to be measured, we have chosen the left ventricular ejection fraction (LVEF) as the main judgement criterion because this measure defines the type of heart failure.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Collaborators
- GIRCI SOHO
- Responsible party
- Sponsor
- Investigators
- Mona Hedreville, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265986
- Sponsor's protocol ID
- PAP_RI2_2019/02
- Acronym
- TER de blueS
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07265986
- Acronym / sponsor ID
- TER de blueS / PAP_RI2_2019/02
- Keywords
- heart failure, remote echocardiography doppler, telemedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Collaborators
- GIRCI SOHO
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 8 Sep 2026 (estimated)
- Study completion
- 8 Sep 2026 (estimated)
- First posted
- 5 Dec 2025 (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.
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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a prospective multicentre study (one cardiologist in a private practice in Guadeloupe and one at the Marie-Galante Hospital) interventional cross-over study in which the measurements obtained successively by tele-echo-cardiography and standard echocardiography will be compared. Among the set of parameters to be measured, we have chosen the left ventricular ejection fraction (LVEF) as the main judgement criterion because this measure defines the type of heart failure.
| Arm | Type | Receives |
|---|---|---|
| Arm A: in situ ultrasound (EIS) performed first | Experimental | Diagnostic Test: in situ echocardiography (EIS), Diagnostic Test: two-dimensional remote echocardiography (TER)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. |
| Arm B: two-dimensional remote echocardiography (TER) performed first | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- 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.
Key exclusion criteria (3 listed)
- Patient requiring urgent cardiological management with transfer to the University Hospital
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 |
|---|---|---|
| in situ echocardiography (EIS)In situ echocardiography (EIS) will be performed by the cardiologist present in Marie-Galante Hospital. | Diagnostic test | Arm A: in situ ultrasound (EIS) performed first, Arm B: two-dimensional remote echocardiography (TER) performed first |
| 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. | Diagnostic test | Arm A: in situ ultrasound (EIS) performed first, Arm B: two-dimensional remote echocardiography (TER) performed first |
Primary outcome
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.
9 secondary outcomes
Agreement Between Echocardiography Techniques for Diagnosis of Cardiac Anomalies
Time frame: Measured at the second visit (V2) at 2 weeks.
Dilated Cardiomyopathy Assessment
Time frame: Measured at Visit 2 (V2), 2 weeks after baseline.
Quantitative Echocardiographic Measures
Time frame: Measured at the second visit (V2) at 2 weeks.
Hypertrophic Cardiomyopathy Assessment
Time frame: Measured at Visit 2 (V2), 2 weeks after baseline.
Valvulopathy Assessment
Time frame: Measured at V2 (2 weeks)
Systolic Pulmonary Arterial Pressure (PAP)
Time frame: Measured at V2 (2 weeks)
Left Ventricular Filling Pressure
Time frame: Measured at V2 (2 weeks)
Duration of Echocardiography
Time frame: Measured at the second visit (V2) at 2 weeks.
Patient Satisfaction
Time frame: Measured at the second visit (V2) at 2 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Mona Hedreville, MD study chair
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing in situ echocardiography (EIS) and two-dimensional remote echocardiography (TER) in people with Heart Failure and Remote Consultation, Teleconsultation, run by Centre Hospitalier Universitaire de la Guadeloupe at 3 sites in Guadeloupe.
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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Guadeloupe. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact melanie petapermal, Master degree (+590590934667, melanie.petapermal@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of Left Ventricular Ejection Fraction (LVEF) Measurements Between Echocardiography Techniques (time frame: Measured at the second visit (V2) at 2 weeks.). 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 5 Dec 2025.