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

Primary Purpose

Diastolic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
elastography function ShearWave Imaging
MRI
Sponsored by
French Cardiology Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diastolic Heart Failure

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hopital Europeen Georges Pompidou

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

healthy volunteers

diastolic Heart Failure

systolic Heart Failure

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

myocardial stiffness ( measured by kPa)

Secondary Outcome Measures

Full Information

First Posted
August 24, 2015
Last Updated
October 31, 2017
Sponsor
French Cardiology Society
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02537041
Brief Title
Non-invasive Evaluation of Myocardial Stiffness by Elastography
Acronym
Elasto-Cardio
Official Title
Non-invasive Evaluation of Myocardial Stiffness by Elastography in the Elderly Suffering From Isolated Diastolic Heart Failure: New Diagnostic Tool?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy volunteers
Arm Type
Other
Arm Description
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.
Arm Title
diastolic Heart Failure
Arm Type
Other
Arm Description
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.
Arm Title
systolic Heart Failure
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
elastography function ShearWave Imaging
Intervention Description
non-invasive assessment of myocardial stiffness by elastography
Intervention Type
Procedure
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
myocardial stiffness ( measured by kPa)
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier VILLEMAIN, MD
Organizational Affiliation
LAngevin Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29550319
Citation
Villemain O, Correia M, Mousseaux E, Baranger J, Zarka S, Podetti I, Soulat G, Damy T, Hagege A, Tanter M, Pernot M, Messas E. Myocardial Stiffness Evaluation Using Noninvasive Shear Wave Imaging in Healthy and Hypertrophic Cardiomyopathic Adults. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 1):1135-1145. doi: 10.1016/j.jcmg.2018.02.002. Epub 2018 Mar 14.
Results Reference
derived

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Non-invasive Evaluation of Myocardial Stiffness by Elastography

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