Recruiting
Not applicable
Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?
Condition(s) studied
Cardiovascular Diseases in Old Age
Investigational drug(s) / intervention(s)
SuperSonic image
SuperSonic image: 3 examen performed assessed to compared evaluation type: Cardiac magnetic resonance imaging, standard ultrasound imaging and ultrafast imaging
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Myocardial stiffness assessment by elastography — Day 1
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Emmanuel MESSAS |
Paris |
France |
Recruiting |
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