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
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