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Non-invasive Evaluation of Myocardial Stiffness by Elastography (Elasto-Cardio)

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ClinicalTrials.gov Identifier: NCT02537041
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
French Cardiology Society

Brief 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.


Condition or disease Intervention/treatment Phase
Diastolic Heart Failure Procedure: elastography function ShearWave Imaging Procedure: MRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Evaluation of Myocardial Stiffness by Elastography in the Elderly Suffering From Isolated Diastolic Heart Failure: New Diagnostic Tool?
Study Start Date : September 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
healthy volunteers
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.
Procedure: elastography function ShearWave Imaging
non-invasive assessment of myocardial stiffness by elastography

Procedure: MRI
diastolic Heart Failure
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.
Procedure: elastography function ShearWave Imaging
non-invasive assessment of myocardial stiffness by elastography

Procedure: MRI
systolic Heart Failure

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

Procedure: elastography function ShearWave Imaging
non-invasive assessment of myocardial stiffness by elastography

Procedure: MRI



Primary Outcome Measures :
  1. myocardial stiffness ( measured by kPa) [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Group 1 "healthy volunteers" (n = 40): two age classes determined ([20-40ans, n = 20] and [60-80 years, n = 20]),
  • 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)
  • Group 3 "systolic HF" (n = 20): elderly patients with heart failure with impaired ejection (<45%) fraction, but no segmental dysfunction

Exclusion Criteria:

  • pregnant woman
  • atrial fibrillation
  • patient with defibrillator, pacemaker
  • contraindication to MRI
  • no consent form
  • echography gel allergy
  • participation to another study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537041


Locations
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France
Hopital Europeen Georges Pompidou
Paris, France, 75015
Sponsors and Collaborators
French Cardiology Society
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Study Chair: Olivier VILLEMAIN, MD LAngevin Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT02537041    
Other Study ID Numbers: 2014-02
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases