Diastolic Heart FailureElasto-CardioNCT02537041
Non-invasive Evaluation of Myocardial Stiffness by Elastography
A study testing elastography function ShearWave Imaging and MRI in people with Diastolic Heart Failure, run by French Cardiology Society at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diastolic Heart Failure
- What is being tested?
- elastography function ShearWave Imaging and MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant woman
- atrial fibrillation
- patient with defibrillator, pacemaker
- contraindication to MRI
- no consent form
- echography gel allergy
- participation to another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Evaluation of Myocardial Stiffness by Elastography in the Elderly Suffering From Isolated Diastolic Heart Failure: New Diagnostic Tool?
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.
Read more
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.
Read the 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.
- Conditions
- Diastolic Heart Failure
- Being tested
- elastography function ShearWave Imaging, MRI
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastography function ShearWave ImagingProcedure or surgery
non-invasive assessment of myocardial stiffness by elastography
MRIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Procedure: elastography function ShearWave Imaging; Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial stiffness ( measured by kPa)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diastolic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier VILLEMAIN, MD, Study chair, LAngevin Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537041
- Sponsor's protocol ID
- 2014-02
- Acronym
- Elasto-Cardio
- Status last verified
- Oct 2017
- First submitted
- 24 Aug 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29550319
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Evaluation of Myocardial Stiffness by Elastography in the Elderly Suffering From Isolated Diastolic Heart Failure: New Diagnostic Tool?
- ClinicalTrials.gov ID
- NCT02537041
- Acronym / sponsor ID
- Elasto-Cardio / 2014-02
- Conditions
- Diastolic Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Sep 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Other | Procedure: elastography function ShearWave Imaging, Procedure: MRIto 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. |
| diastolic Heart Failure | Other | Procedure: elastography function ShearWave Imaging, Procedure: MRIolder 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. |
| systolic Heart Failure | Other | Procedure: elastography function ShearWave Imaging, Procedure: MRIelderly 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- pregnant woman
- atrial fibrillation
- patient with defibrillator, pacemaker
- contraindication to MRI
- no consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elastography function ShearWave Imagingnon-invasive assessment of myocardial stiffness by elastography | Procedure or surgery | diastolic Heart Failure, healthy volunteers, systolic Heart Failure |
| MRI | Procedure or surgery | diastolic Heart Failure, healthy volunteers, systolic Heart Failure |
Primary outcome
myocardial stiffness ( measured by kPa)
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 29550319Villemain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier VILLEMAIN, MD study chair
LAngevin Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing elastography function ShearWave Imaging and MRI in people with Diastolic Heart Failure, run by French Cardiology Society at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial stiffness ( measured by kPa) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02537041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.