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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorFrench Cardiology Society

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy.

Poor echogenicity.

Allergy to echocardiography gel.

Associated pulmonary disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • SuperSonic image

    Diagnostic test

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

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: StratificationOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1

Secondary outcomes

1

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).

Time frame
Day 1
2

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.

Time frame
Day 1
3

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

Time frame
Day 1
4

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

Time frame
Day 1

Other outcomes

Sponsors and contacts

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