Non-invasive Evaluation of Myocardial Stiffness by Elastography

NCT02537041 | Completed

• 1 other identifier: 2014-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastolic Heart Failure

Outcome Measures

Primary Outcomes (1)

• myocardial stiffness ( measured by kPa)

  18 months

Study Arms (3)

healthy volunteers

OTHER

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; Procedure: MRI

diastolic Heart Failure

OTHER

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; Procedure: MRI

systolic Heart Failure

OTHER

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; Procedure: MRI

Interventions

elastography function ShearWave Imaging PROCEDURE

non-invasive assessment of myocardial stiffness by elastography

diastolic Heart Failure; healthy volunteers; systolic Heart Failure

MRI PROCEDURE

diastolic Heart Failure; healthy volunteers; systolic Heart Failure

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• French Cardiology Society: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

• 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.

  PMID: 29550319 DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Olivier VILLEMAIN, MD

  LAngevin Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-10

Locations

FR (1)