NCT03895541Recruiting
Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 28 Mar 2019
- Start date
- 24 Jan 2020
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- French Cardiology Society
- Diseases
- Heart failure
- NCT number
- NCT03895541
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 24 Jan 2020 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emmanuel MESSAS Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.