Cardiovascular Diseases in Old AgeELASTOCARDIO2NCT03895541
Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?
A study testing SuperSonic image in people with Cardiovascular Diseases in Old Age, run by French Cardiology Society at 1 site in France.
Trial summary
The new approach propose in this protocol is based on ultrafast ultrasound and remote palpation of tissue by ultrasonic radiation pressure. Ultrafast ultrasound of biological tissues is based on an innovative ultrasound imaging approach that can image very fast soft tissue events at a rate of several thousands of… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular Diseases in Old Age
- What is being tested?
- SuperSonic image
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2020to 31 Dec 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
General inclusion criteria:
- Subjects who have received information about the study and signed the informed consent form.
- Beneficiary of a social security scheme.
- Age ≥18 years.
- Hospitalization in a cardiology department.
Specific inclusion criteria:
HFpEF group (preserved left ventricular ejection fraction):
- Left ventricular ejection fraction (LVEF) ≥50%.
- BNP ≥35 pg/mL or NT-proBNP ≥135 pg/mL.
- At least one of the following:
- Echocardiographic structural alteration: left atrial dilatation (biplane volume ≥34 mL/m²) or left ventricular hypertrophy (LV mass index ≥115 g/m² in men or ≥95 g/m² in women).
- Echocardiographic functional alteration: criteria of diastolic dysfunction including E >50 cm/s, mean septal-lateral e' <9 cm/s, E/e' ≥13, or peak tricuspid regurgitation velocity ≥2.8 m/s.
- For 25 patients: documented cardiac amyloidosis.
HFmrEF group (moderately reduced left ventricular ejection fraction):
- LVEF between 40% and 49%.
- BNP ≥35 pg/mL or NT-proBNP ≥135 pg/mL.
- At least one of the following:
- Echocardiographic structural alteration: left atrial dilatation (biplane volume ≥34 mL/m²) or left ventricular hypertrophy (LV mass index ≥115 g/m² in men or ≥95 g/m² in women).
- Echocardiographic functional alteration: criteria of diastolic dysfunction including mean septal-lateral e' <9 cm/s, E/e' ≥13, or peak tricuspid regurgitation velocity ≥2.8 m/s.
HFrEF group (reduced left ventricular ejection fraction):
- Diagnosis of heart failure with reduced ejection fraction according to the ESC Guidelines.
- Presence of symptoms of heart failure.
- Presence of clinical signs of heart failure.
- LVEF <40%.
General exclusion criteria:
- Pregnancy.
- Poor echogenicity.
- Allergy to echocardiography gel.
Specific exclusion criteria:
HFpEF group:
- Associated pulmonary disease.
- Regional wall motion abnormality.
HFmrEF group:
- Associated pulmonary disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Emmanuel MESSAS
Paris, 75015
Emmanuel MESSAS, Pr, 33 6 65 03 85 02, emmanuel.messas@aphp.fr
Samuel ZARKA, Dr, 33 1 56 09 37 55, samuel.zarka@aphp.fr
About this study
The new approach propose in this protocol is based on ultrafast ultrasound and remote palpation of tissue by ultrasonic radiation pressure. Ultrafast ultrasound of biological tissues is based on an innovative ultrasound imaging approach that can image very fast soft tissue events at a rate of several thousands of frames per second and provide quantitative mapping of the elasticity of the tissues. This current project aims is to focus on myocardial rigidity in diastole to better assess the function of the heart failure.
Read the detailed description
Diastolic heart failure or heart failure with preserved systolic function is the leading cause of heart failure in elderly subjects (more than 2/3 of heart failure in subjects over 60 years). Its main etiology is high blood pressure. Diagnosis of diastolic heart failure remains controversial in clinical practice. It is based on ultrasound and biological criteria. These are mainly acute edema of the lung for patients with preserved Ejection Fraction and high Brain Natriuretic Peptid. It is now recognized that the "primum movens" of this type of heart failure is the increase in myocardial stiffness secondary to left ventricular hypertrophy. The noninvasive evaluation of this parameter would allow a more accurate and reliable diagnosis since it does not depend on the loading conditions, unlike the heart failure and the trans-mitral Doppler). However, the absence of a non-invasive tool for the direct evaluation of diastolic (so-called passive) rigidity prevents the use of this diagnostic parameter. Investigators propose here to non-invasively evaluate the myocardial stiffness in the elderly patient with diastolic heart failure thanks to a new imaging tool using an innovative ultrasonic technology, the ultrafast-echo associated with its elastographic mode "ShearWave Imaging". Investigators have been working for several years in collaboration with the Langevin Institute on this technology, which has recently been validated on experimental models. Its principle is based on the creation of a shear wave from a standard ultrasound probe and the calculation of the velocity of this wave thanks to the very high temporal resolution of the ultrasound system, this speed being correlated to the myocardial rigidity. The human study was recently made possible by the development of a phased array probe with the ability to work with the elastography mode ("ShearWave Imaging").
- Conditions
- Cardiovascular Diseases in Old Age
- Being tested
- SuperSonic image
- Keywords
- heart failure, myocardial rigidity, new diagnosis, ultrasound imaging
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperSonic imageDiagnostic test
3 examen performed assessed to compared evaluation type: Cardiac magnetic resonance imaging, standard ultrasound imaging and ultrafast imaging
| Study group | Role | What they receive |
|---|---|---|
| Stratification | Other | All patient will have the same intervention. They will be stratified regarding their degree of heart failure gravity.
* HFpEF : 80 patients (including 25 with cardiac amyloidosis)
* HFmrEF : 30 patients
* HFrEF : 30 patients Receives: Diagnostic Test: SuperSonic image |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial stiffness assessment by elastography
Assessment of myocardial stiffness using non-invasive ultrasound elastography, and comparison of the elastography-derived myocardial stiffness parameters with conventional echocardiographic and biological parameters used for the diagnosis of diastolic heart failure.
Measured: Day 1
Secondary outcomes (4)
Norms estimation of myocardial rigidity
Estimation of physiological and pathological norms of myocardial rigidity by elastography to detect and diagnose heart failure according to the left ventricular ejection fraction phenotype (HFpEF, HFmrEF and HFrEF).
Measured: Day 1
Characterization of myocardial stiffness in patients with HFpEF
Evaluation of myocardial stiffness assessed by elastography in a larger population of patients with heart failure with preserved ejection fraction (LVEF ≥50%), including characterization of patients with and without documented cardiac amyloidosis.
Measured: Day 1
Diagnostic parameters of SWI in cardiac amyloidosis
Evaluation of differences in myocardial stiffness and other ShearWave Imaging -derived parameters between patients with HFpEF with and without documented cardiac amyloidosis, in order to further characterize the diagnostic performance of ShearWave Imaging
Measured: Day 1
Safety of cardiac elastography
patient monitoring (electrocardiogram scope and constants every10 min) for 30 minutes post-examination associated with a "comfort questionnaire" to be completed by the patient after the examination
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start24 Jan 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases in Old AgeStudies 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
- Model description
- stratification
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel MESSAS, MD, Principal investigator, Hopital Européen Georges Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895541
- Sponsor's protocol ID
- 2017-04
- Acronym
- ELASTOCARDIO2
- Status last verified
- Oct 2026
- First submitted
- 28 Mar 2019
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?
- ClinicalTrials.gov ID
- NCT03895541
- Acronym / sponsor ID
- ELASTOCARDIO2 / 2017-04
- Conditions
- Cardiovascular Diseases in Old Age
- Keywords
- heart failure, myocardial rigidity, new diagnosis, ultrasound imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Mar 2019 (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 new approach propose in this protocol is based on ultrafast ultrasound and remote palpation of tissue by ultrasonic radiation pressure. Ultrafast ultrasound of biological tissues is based on an innovative ultrasound imaging approach that can image very fast soft tissue events at a rate of several thousands of frames per second and provide quantitative mapping of the elasticity of the tissues. This current project aims is to focus on myocardial rigidity in diastole to better assess the function of the heart failure.
Detailed description
Diastolic heart failure or heart failure with preserved systolic function is the leading cause of heart failure in elderly subjects (more than 2/3 of heart failure in subjects over 60 years). Its main etiology is high blood pressure. Diagnosis of diastolic heart failure remains controversial in clinical practice. It is based on ultrasound and biological criteria. These are mainly acute edema of the lung for patients with preserved Ejection Fraction and high Brain Natriuretic Peptid. It is now recognized that the "primum movens" of this type of heart failure is the increase in myocardial stiffness secondary to left ventricular hypertrophy. The noninvasive evaluation of this parameter would allow a more accurate and reliable diagnosis since it does not depend on the loading conditions, unlike the heart failure and the trans-mitral Doppler). However, the absence of a non-invasive tool for the direct evaluation of diastolic (so-called passive) rigidity prevents the use of this diagnostic parameter. Investigators propose here to non-invasively evaluate the myocardial stiffness in the elderly patient with diastolic heart failure thanks to a new imaging tool using an innovative ultrasonic technology, the ultrafast-echo associated with its elastographic mode "ShearWave Imaging". Investigators have been working for several years in collaboration with the Langevin Institute on this technology, which has recently been validated on experimental models. Its principle is based on the creation of a shear wave from a standard ultrasound probe and the calculation of the velocity of this wave thanks to the very high temporal resolution of the ultrasound system, this speed being correlated to the myocardial rigidity. The human study was recently made possible by the development of a phased array probe with the ability to work with the elastography mode ("ShearWave Imaging").
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- stratification
| Arm | Type | Receives |
|---|---|---|
| Stratification | Other | Diagnostic Test: SuperSonic imageAll patient will have the same intervention. They will be stratified regarding their degree of heart failure gravity. * HFpEF : 80 patients (including 25 with cardiac amyloidosis) * HFmrEF : 30 patients * HFrEF : 30 patients |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SuperSonic image3 examen performed assessed to compared evaluation type: Cardiac magnetic resonance imaging, standard ultrasound imaging and ultrafast imaging | Diagnostic test | Stratification |
Primary outcome
Myocardial stiffness assessment by elastography
Time frame: Day 1
Assessment of myocardial stiffness using non-invasive ultrasound elastography, and comparison of the elastography-derived myocardial stiffness parameters with conventional echocardiographic and biological parameters used for the diagnosis of diastolic heart failure.
4 secondary outcomes
Norms estimation of myocardial rigidity
Time frame: Day 1
Characterization of myocardial stiffness in patients with HFpEF
Time frame: Day 1
Diagnostic parameters of SWI in cardiac amyloidosis
Time frame: Day 1
Safety of cardiac elastography
Time frame: Day 1
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 9 Oct 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.
Emmanuel MESSAS, MD principal investigator
Hopital Européen Georges Pompidou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SuperSonic image in people with Cardiovascular Diseases in Old Age, run by French Cardiology Society at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Emmanuel MESSAS, MD (33 6 65 03 85 02, emmanuel.messas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial stiffness assessment by elastography (time frame: Day 1). 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 9 Oct 2026.