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

NCT ID: NCT03895541

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-24
• Study Completion Date: 2025-12-31

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").

Conditions

Cardiovascular Diseases in Old Age

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Stratification

All patient will have the same intervention. They will be stratified regarding their degree of heart failure gravity.

Group Type: OTHER

SuperSonic image

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

SuperSonic image

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Hospitalization in cardiology services for acute pulmonary edema during heart failure
• Natriuretic peptide type B ≥35 pg/ml
• Echocardiographic structural alteration

• 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%

Exclusion Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French Cardiology Society

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel MESSAS, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Européen Georges Pompidou

Locations

Emmanuel MESSAS

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Emmanuel MESSAS, MD

Role: CONTACT

emmanuel.messas@aphp.fr

33 6 65 03 85 02

Tessa BERGOT

Role: CONTACT

tessa.bergot@sfcardio.fr

33 144907033

Facility Contacts

Emmanuel MESSAS, Pr

Role: primary

emmanuel.messas@aphp.fr

33 6 65 03 85 02

Samuel ZARKA, Dr

Role: backup

samuel.zarka@aphp.fr

33 1 56 09 37 55

Other Identifiers

2017-04

Identifier Type: -

Identifier Source: org_study_id