Age 65 and OlderUPCOMINGNCT07427303
Focused Echocardiography for Primary Care Physicians
A study testing point of care ultrasound in people with Age 65 and Older and Cardiac Risk Factors, run by University Hospital, Caen.
Trial summary
Our society is characterized by a steady improvement in the standard of living of its inhabitants, which is reflected, among other things, in improved healthcare and quality of life (longer life expectancy, lower infant mortality, treatment of chronic diseases, cancer plan). Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Age 65 and Older, Cardiac Risk Factors, Dyspnea; Cardiac
- What is being tested?
- point of care ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 May 2027
- 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 65 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and women aged 65 or older with no cardiac symptoms and presenting with a treated or untreated cardiovascular risk factor (hypertension and/or diabetes and/or dyslipidemia) or
- Adult men and women presenting with one of the following signs:
- Stage I-II exertional dyspnea
- Lower limb edema
- Unexplained fatigue
- Weight gain
- Unexplained cough
- History of carpal tunnel surgery (search for signs of myocardial infiltration by cardiac amyloidosis)
Who cannot join
- Patients with arrhythmia or ventricular or supraventricular hyper excitability.
- Symptomatic patients:
- exertional dyspnea (NYHA >2)
- palpitations
- malaise
- chest pain
Show all 15Show fewer
- Obese individuals with a BMI >35
- Patients with breast implants
- Patients under guardianship, conservatorship, or legal protection
- Patients without health insurance coverage or equivalent
- Patients known to have heart disease
- Patients who have had a cardiology consultation within the last 5 years
- Subjects with known heart disease, whether monitored or not.
- Known valvular heart disease (whether monitored or not)
- Known coronary artery disease (whether monitored or not)
About this study
Official title: CLINICAL FEASIBILITY OF ULTRAPORTABLE CARDIAC ULTRASOUND PERFORMED IN THE GENERAL PRACTITIONER'S OFFICE TO IDENTIFY CARDIOVASCULAR ABNORMALITIES
Our society is characterized by a steady improvement in the standard of living of its inhabitants, which is reflected, among other things, in improved healthcare and quality of life (longer life expectancy, lower infant mortality, treatment of chronic diseases, cancer plan). Many factors contribute to this, but technological innovations and therapeutic advances are the main ones. This positive overall picture should not obscure the fact that there are significant regional disparities.
For more than 15 years, the former Lower Normandy region (Calvados, Manche, and Orne), like many other regions in France, has been marked by increasingly complex access to healthcare, whether for primary care or for so-called specialty disciplines. This situation is gradually leading to the creation of medical deserts. There are many reasons for this (numerus clausus, sociological changes, urbanization of young practitioners, attraction of small rural towns by medium-sized cities), which are chronic and have no clearly identified solution.
Read more
This situation complicates patient care and, in some cases, represents a major public health challenge, such as in the treatment of heart failure (HF), which affects more than one million people in France, or 2.3% of the adult population. For 2.3 times more deaths each year than strokes and five times more than myocardial infarctions.
Some healthcare innovations can reduce the consequences of these areas of stress. In the field of cardiology, recent initiatives based on the creation of specialized cardiology and telemedicine care teams have been proposed. In primary care, point-of-care solutions enable many tests to be performed on an outpatient basis. Imaging plays a central role in patient care, and ultrasound is often the first-line modality in cardiology. Technological innovations in this field have made it possible to miniaturize ultrasound machines to such an extent that some of them can now be considered POCUS (point-of-care ultrasound). Their reduced manufacturing costs, combined with the maturity of the technique, make it possible to offer simplified acquisition protocols adapted to specific questions, known as targeted clinical ultrasound.
This simplification/miniaturization of ultrasound equipment has facilitated the spread of this technique outside the field of cardiology and now allows for its use by general practitioners close to patients, specifically for screening purposes. Many diseases would benefit from early screening in order to reduce hospitalizations, mortality, and societal costs. In cardiology, this approach remains difficult because the majority of patients admitted to healthcare facilities have already developed the disease. HF is characterized by an initial silent phase which, if left untreated, inevitably leads to complications and death. It is responsible for 200,000 hospitalizations per year in France, causing the deaths of 70,000 people. Certain signs, grouped under the French acronym EPOF, appear early on and can be warning signs, but they are often vague and unfamiliar to the general public. This fact is well illustrated by the results of a survey conducted by the Heart Failure and Cardiomyopathy Group (GICC) of the French Society of Cardiology (SFC) in 2017 (5,000 subjects representative of the French population aged 18 to 80). This survey noted that two-thirds of subjects presenting four of these signs (EPOF) had not consulted a cardiologist in the 12 months prior to the questionnaire. In the majority of cases, these patients, whether asymptomatic or paucisymptomatic (EPOF), have morphological and functional abnormalities of the heart, which are the first step toward more severe complications and can be detected by cardiac echocardiography.
There is currently a favorable alignment between echocardiography as a public health need (early detection of conditions that can lead to heart failure) and frontline practitioners (general practitioners). This alignment could lead to the definition of new practices and a new care pathway. While echocardiography is technically feasible in a general practitioner's office, its implementation remains to be evaluated (HAS report). This report emphasizes the lack of data in the literature to identify use cases and clinical impact in general medicine in France.
- Conditions
- Age 65 and Older, Cardiac Risk Factors, Dyspnea; Cardiac, Oedema, Fatigability, Cough
- Being tested
- point of care ultrasound
- Medical subject headings
- Dyspnea, Edema, Cough, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
point of care ultrasoundDevice
TargetedClinical Ultrasound exam
| Study group | Role | What they receive |
|---|---|---|
| Targeted Echo Group | Active comparator | Not described Receives: Device: point of care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical feasibility of cardiac ultrasound performed in a GP office within the specific framework of the proposed acquisition protocol.
Concordance between the interpretation by the general practitioner and by the expert of the ECC1 examination performed by the general practitioner in his office in the study population
Measured: The targeted ultrasound performed by the general practitioner will be reviewed by the specialist within 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age 65 and OlderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427303
- Sponsor's protocol ID
- 23-0197
- Other IDs
- 2023-A02068-37
- Acronym
- UPCOMING
- Status last verified
- Feb 2026
- First submitted
- 22 Sep 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL FEASIBILITY OF ULTRAPORTABLE CARDIAC ULTRASOUND PERFORMED IN THE GENERAL PRACTITIONER'S OFFICE TO IDENTIFY CARDIOVASCULAR ABNORMALITIES
- ClinicalTrials.gov ID
- NCT07427303
- Acronym / sponsor ID
- UPCOMING / 23-0197
- Conditions
- Age 65 and Older, Cardiac Risk Factors, Dyspnea; Cardiac, Oedema, Fatigability, Cough
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 23 Feb 2026 (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.
Our society is characterized by a steady improvement in the standard of living of its inhabitants, which is reflected, among other things, in improved healthcare and quality of life (longer life expectancy, lower infant mortality, treatment of chronic diseases, cancer plan). Many factors contribute to this, but technological innovations and therapeutic advances are the main ones. This positive overall picture should not obscure the fact that there are significant regional disparities.
For more than 15 years, the former Lower Normandy region (Calvados, Manche, and Orne), like many other regions in France, has been marked by increasingly complex access to healthcare, whether for primary care or for so-called specialty disciplines. This situation is gradually leading to the creation of medical deserts. There are many reasons for this (numerus clausus, sociological changes, urbanization of young practitioners, attraction of small rural towns by medium-sized cities), which are chronic and have no clearly identified solution.
This situation complicates patient care and, in some cases, represents a major public health challenge, such as in the treatment of heart failure (HF), which affects more than one million people in France, or 2.3% of the adult population. For 2.3 times more deaths each year than strokes and five times more than myocardial infarctions.
Some healthcare innovations can reduce the consequences of these areas of stress. In the field of cardiology, recent initiatives based on the creation of specialized cardiology and telemedicine care teams have been proposed. In primary care, point-of-care solutions enable many tests to be performed on an outpatient basis. Imaging plays a central role in patient care, and ultrasound is often the first-line modality in cardiology. Technological innovations in this field have made it possible to miniaturize ultrasound machines to such an extent that some of them can now be considered POCUS (point-of-care ultrasound). Their reduced manufacturing costs, combined with the maturity of the technique, make it possible to offer simplified acquisition protocols adapted to specific questions, known as targeted clinical ultrasound.
This simplification/miniaturization of ultrasound equipment has facilitated the spread of this technique outside the field of cardiology and now allows for its use by general practitioners close to patients, specifically for screening purposes. Many diseases would benefit from early screening in order to reduce hospitalizations, mortality, and societal costs. In cardiology, this approach remains difficult because the majority of patients admitted to healthcare facilities have already developed the disease. HF is characterized by an initial silent phase which, if left untreated, inevitably leads to complications and death. It is responsible for 200,000 hospitalizations per year in France, causing the deaths of 70,000 people. Certain signs, grouped under the French acronym EPOF, appear early on and can be warning signs, but they are often vague and unfamiliar to the general public. This fact is well illustrated by the results of a survey conducted by the Heart Failure and Cardiomyopathy Group (GICC) of the French Society of Cardiology (SFC) in 2017 (5,000 subjects representative of the French population aged 18 to 80). This survey noted that two-thirds of subjects presenting four of these signs (EPOF) had not consulted a cardiologist in the 12 months prior to the questionnaire. In the majority of cases, these patients, whether asymptomatic or paucisymptomatic (EPOF), have morphological and functional abnormalities of the heart, which are the first step toward more severe complications and can be detected by cardiac echocardiography.
There is currently a favorable alignment between echocardiography as a public health need (early detection of conditions that can lead to heart failure) and frontline practitioners (general practitioners). This alignment could lead to the definition of new practices and a new care pathway. While echocardiography is technically feasible in a general practitioner's office, its implementation remains to be evaluated (HAS report). This report emphasizes the lack of data in the literature to identify use cases and clinical impact in general medicine in France.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted Echo Group | Active comparator | Device: point of care ultrasound |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Men and women aged 65 or older with no cardiac symptoms and presenting with a treated or untreated cardiovascular risk factor (hypertension and/or diabetes and/or dyslipidemia) or
- Adult men and women presenting with one of the following signs:
Key exclusion criteria (15 listed)
- Patients with arrhythmia or ventricular or supraventricular hyper excitability.
- Symptomatic patients:
- Obese individuals with a BMI >35
- Patients with breast implants
- Patients under guardianship, conservatorship, or legal protection
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 |
|---|---|---|
| point of care ultrasoundTargetedClinical Ultrasound exam | Device | Targeted Echo Group |
Primary outcome
Clinical feasibility of cardiac ultrasound performed in a GP office within the specific framework of the proposed acquisition protocol.
Time frame: The targeted ultrasound performed by the general practitioner will be reviewed by the specialist within 72 hours.
Concordance between the interpretation by the general practitioner and by the expert of the ECC1 examination performed by the general practitioner in his office in the study population
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 23 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing point of care ultrasound in people with Age 65 and Older and Cardiac Risk Factors, run by University Hospital, Caen.
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 15 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: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Clinical feasibility of cardiac ultrasound performed in a GP office within the specific framework of the proposed acquisition protocol. (time frame: The targeted ultrasound performed by the general practitioner will be reviewed by the specialist within 72 hours.). 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 23 Feb 2026.