Clinical trial NCT02619825: Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie)
Official title: Non-Invasive Evaluation of Myocardial Stiffness by Elastography Pediatric Cardiology Under
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dilated Cardiomyopathy
Hypertrophic Cardiomyopathy
Keywords: Child
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: First, investigators must determine the physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness \[VD\] and left ventricular \[LV\]). This will be done in groups of children without heart condition, age group (10 children per group, four age groups \[0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years\]).

Secondly, investigators will evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with cardiomyopathy and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values. The total population of the study will be 120 children (40 healthy, 80 patients).

Detailed description: Monocenter Prospective, open-label, non-randomized. All patients included in the study have a specific consultation built around a clinical examination and echocardiography, in two stages, with estimates of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measures of all echocardiographic parameters estimated in children with a clinical ultrasound machine (Philips and General Electric).

Following this consultation, clinic and electrocardiographic monitoring period will be observed for 30 minutes, to ensure the safety of our procedure.

Required subjects: 40 healthy volunteers + 80 = 120 persons

Eligibility criteria: Inclusion Criteria:

Group 1. Healthy Age criteria met by group \[0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years\]

* consultation for heart murmur
* Recipient of a social protection scheme or entitled (excluding AME)
* Signed informed consent by the holders of parental authority

Group 2. Patients MHC nonobstructive:

* Age criteria met by group \[1 month-1 year 1 year-5 years\]
* Diagnostic criteria of non-obstructive HCM validated by the medical team of pediatric cardiology center (Necker)
* Recipient of a social protection scheme or entitled (excluding AME)
* Signed informed consent by the holders of parental authority

Group 3. Patients primitive CMD:

* Age criteria met by group \[1 month-1 year 1 year-5 years\]
* Diagnostic criteria of primary CMD validated by the medical team of pediatric cardiology center (Necker)
* Recipient of a social protection scheme or entitled (excluding AME)
* Signed informed consent

Exclusion Criteria:

Group 1. Healthy Patients:

* Age\> 15 years
* Heart and Systemic Pathology identified
* metabolic and tissue pathology.
* known genetic pathology may have cardiac involvement.
* No echogenicity,
* Allergy echocardiography gel.

Group 2. Group CMH primitive Patients

* No echogenicity,,
* Allergy echocardiography gel.
* Arrhythmia.
* Pacemaker or defibrillator

Group 3. Patients primitive CMD:

* No echogenicity,,
* Allergy echocardiography gel.
* Arrhythmia.
* Pacemaker or defibrillator

Primary outcomes:
measure: Myocardial diastolic stiffness UltrafastEcho (kPa)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Chu Necker
Study officials:
affiliation: LAngevin Institute
name: Olivier VILLEMAIN, MD
role: STUDY_CHAIR
References: