Non-invasive Evaluation of Myocardial Stiffness by Elastography
Condition: Diastolic Heart Failure
MeSH terms: Heart Failure; Heart Failure, Diastolic
Study type: Interventional

Summary: 
      SITUATION ON RESEARCH Diastolic heart failure (HF) or heart failure with preserved systolic
      function (SF) is the primary cause of heart failure in the elderly (over 2/3 of heart failure
      in patients over 60 years). Its main cause is hypertension. The diagnosis of diastolic heart
      failure is still controversial in clinical practice. It is based on ultrasound and biological
      criteria (or MRI). Basically, it is concerned patients making acute pulmonary edema with
      preserved SF and high BNP. It is now recognized that the "primum movens" of this type of HF
      is increased myocardial stiffness secondary to LVH. Noninvasive assessment of this parameter
      would allow a more accurate and reliable diagnosis because not dependent on load conditions
      unlike the ejection fraction (EF) and trans-mitral Doppler. However, the absence of
      non-invasive tool for the direct evaluation of the diastolic stiffness (so-called passive)
      prevents to date to use this diagnostic parameter.

      The investigators propose here to evaluate noninvasively myocardial stiffness in elderly
      patients with diastolic heart failure using a new imaging tool that uses an innovative
      ultrasonic technology, the ultrafast echo associated with its elastography function
      "ShearWave Imaging" (SWI). The investigators work for several years in collaboration with the
      Langevin Institute on this technology which was recently validated in experimental models.
      Its principle is based on the creation of a shear wave from a standard ultrasound and
      calculating the velocity of this wave with the high time resolution of the ultrasound probe,
      this being correlated with the speed myocardial stiffness.

      The human study was recently made possible by the development of a phased array probe having
      the opportunity to work with elastography mode (SWI).

      PURPOSE OF RESEARCH The goal will be to demonstrate the interest of the non-invasive
      evaluation by ultrafast echo (SWI) of myocardial stiffness in the diagnosis of diastolic
      heart failure in the elderly.
    

Detailed description: 
      DESCRIPTION PROJECT SUMMARY

      Three groups of patients in sinus rhythm will be studied (n total = 100 patients):

        -  Group 1 "healthy volunteers" (n = 40): two age classes determined ([20-40ans, n = 20]
           and [60-80 years, n = 20]), to obtain normal values diastolic myocardial stiffness
           references. The objective will be to confirm the increase with age in myocardial
           stiffness assessed by elastography in healthy subjects.

        -  Group 2 "diastolic HF" (n = 40): older patients with isolated diastolic HF (EF> 45%,
           60-80 years, n = 20) and infiltrative cardiomyopathy restrictive-type amyloidosis (n =
           20) . The objective will be to study the results of elastography on two separate
           clinical types of IC diastolic well identified.

        -  Group 3 "systolic HF" (n = 20): elderly patients with heart failure with impaired
           ejection (<45%) fraction, but no segmental dysfunction.

      The evaluation of myocardial stiffness by elastography in all these patients will be compared
      to conventionally ultrasound and biological parameters currently used for diagnosis of
      elderly's diastolic HF. Our hypothesis is that myocardial stiffness assessed by SWI is a
      powerful parameter for predicting diastolic heart failure. To this end, a univariate and
      multivariate statistical analysis will be carried out from all of these data.

      EXPECTED RESULTS AND OUTLOOK The current ultrasound diagnostic parameters of diastolic heart
      failure (ESC 2012) using Doppler (trans-mitral tissue) anatomical, or functional (strain,
      strain rate, speckle tracking) criteria that are dependent on load conditions and are not
      specific to diastolic HF. This study should demonstrate the continuity of our preclinical
      studies, the non-invasive assessment of myocardial stiffness by elastography is a powerful
      test for the detection and diagnosis of diastolic heart failure. Secondly the prognosis
      character of recovery rates will be studied over a large population of people with HF and FE
      preserved (diastolic HF) with longitudinal follow-up.
    

Intervention name(s): elastography function ShearWave Imaging; MRI
Intervention type(s): Procedure; Procedure
Intervention description(s): non-invasive assessment of myocardial stiffness by elastography
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic