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NCT Number: NCT03895541

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

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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").

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

SuperSonic image

Diagnostic Test

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

Primary outcomes

  1. Myocardial rigidity assessment

    Time frame: Day 1

    Myocardial rigidity measured using this new non-invasive ultrasound imaging technique.

Secondary outcomes

  1. Norms estimation of myocardial rigidity

    Time frame: Day 1

    Estimation of physiological and pathological norms of myocardial rigidity by elastography

  2. Safety of cardiac elastography

    Time frame: Day 1

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel MESSAS, MD

CONTACT

[email protected]

33 6 65 03 85 02

Tessa BERGOT

CONTACT

[email protected]

33 144907033

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: ELASTOCARDIO2

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2019
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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