AzTrials
AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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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
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.

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 groups in NCT07427303
Study groupRoleWhat they receive
Targeted Echo GroupActive comparatorNot described
Receives: Device: point of care ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted23 Feb 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

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)
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

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.

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