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Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?

Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03895541
Acronym
ELASTOCARDIO2
Enrollment
90
Registered
2019-03-29
Start date
2020-01-24
Completion date
2025-12-31
Last updated
2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases in Old Age

Keywords

heart failure, myocardial rigidity, new diagnosis, ultrasound imaging

Brief 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 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).

Interventions

DIAGNOSTIC_TESTSuperSonic image

3 examen performed assessed to compared evaluation type: Cardiac magnetic resonance imaging, standard ultrasound imaging and ultrafast imaging

Sponsors

French Cardiology Society
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

stratification

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Global Inclusion Criteria: * Hospitalization in cardiology services for acute pulmonary edema during heart failure * Natriuretic peptide type B ≥35 pg/ml * Echocardiographic structural alteration Specific Inclusion criteria * Group preserved LVEF: Left ventricular Ejection Fraction ≥50% * Group moderate alteration of LVEF: Left ventricular Ejection Fraction between 40% and 49% * Group Systolic heart failure: Left ventricular Ejection Fraction\< 40% Global

Exclusion criteria

* Other associated lung pathology * Other heart disease * Contraindication to MRI or echocardiography gel * Pregnancy * Poor echogenicity,

Design outcomes

Primary

MeasureTime frameDescription
Myocardial rigidity assessmentDay 1Myocardial rigidity measured using this new non-invasive ultrasound imaging technique.

Secondary

MeasureTime frameDescription
Norms estimation of myocardial rigidityDay 1Estimation of physiological and pathological norms of myocardial rigidity by elastography
Safety of cardiac elastographyDay 1patient 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

Countries

France

Contacts

Primary ContactEmmanuel MESSAS, MD
emmanuel.messas@aphp.fr33 6 65 03 85 02
Backup ContactTessa BERGOT
tessa.bergot@sfcardio.fr33 144907033

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026