Dilated CardiomyopathyNCT02619825
Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie)
A study testing Echography and Elastography in people with Dilated Cardiomyopathy and Hypertrophic Cardiomyopathy, run by French Cardiology Society at 1 site in France.
Trial summary
First, investigators must determine the physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness [VD] and left ventricular [LV]). Read more about this study
- Who is it for?
- Ages 1 day to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy
- What is being tested?
- Echography and Elastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Nov 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 1 day to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Group 1. Healthy Age criteria met by group [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]
- consultation for heart murmur
- Recipient of a social protection scheme or entitled (excluding AME)
- Signed informed consent by the holders of parental authority
- Group 2. Patients MHC nonobstructive:
- Age criteria met by group [1 month-1 year 1 year-5 years]
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- Diagnostic criteria of non-obstructive HCM validated by the medical team of pediatric cardiology center (Necker)
- Recipient of a social protection scheme or entitled (excluding AME)
- Signed informed consent by the holders of parental authority
- Group 3. Patients primitive CMD:
- Age criteria met by group [1 month-1 year 1 year-5 years]
- Diagnostic criteria of primary CMD validated by the medical team of pediatric cardiology center (Necker)
- Recipient of a social protection scheme or entitled (excluding AME)
- Signed informed consent
Who cannot join
- Group 1. Healthy Patients:
- Age> 15 years
- Heart and Systemic Pathology identified
- metabolic and tissue pathology.
- known genetic pathology may have cardiac involvement.
- No echogenicity,
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- Allergy echocardiography gel.
- Group 2. Group CMH primitive Patients
- No echogenicity,,
- Allergy echocardiography gel.
- Arrhythmia.
- Pacemaker or defibrillator
- Group 3. Patients primitive CMD:
- No echogenicity,,
- Allergy echocardiography gel.
- Arrhythmia.
- Pacemaker or defibrillator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Evaluation of Myocardial Stiffness by Elastography Pediatric Cardiology Under
First, investigators must determine the physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness [VD] and left ventricular [LV]). This will be done in groups of children without heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]).
Secondly, investigators will evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with cardiomyopathy and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values. The total population of the study will be 120 children (40 healthy, 80 patients).
Read the detailed description
Monocenter Prospective, open-label, non-randomized. All patients included in the study have a specific consultation built around a clinical examination and echocardiography, in two stages, with estimates of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measures of all echocardiographic parameters estimated in children with a clinical ultrasound machine (Philips and General Electric).
Following this consultation, clinic and electrocardiographic monitoring period will be observed for 30 minutes, to ensure the safety of our procedure.
Required subjects: 40 healthy volunteers + 80 = 120 persons
- Being tested
- Echography, Elastography
- Keywords
- Child
- Medical subject headings
- Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchographyDevice
cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measurement of all echocardiographic parameters estimated in children with a clinical ultrasound Machine
ElastographyDevice
cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and
| Study group | Role | What they receive |
|---|---|---|
| Group 1 "healthy volunteers | Other | Echography and Elastography To determine physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness [VD] and left ventricular [LV]). This will be done in groups of children without heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]). Receives: Device: Echography; Device: Elastography |
| Group 2 Patients CMH primitive | Other | Echography and Elastography To evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with Hypertrophic Cardiomyopathy (HCM) non obstructive primitive and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values. Receives: Device: Echography; Device: Elastography |
| Group 3 Patients primitive CMD: | Other | Echography and Elastography To evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with Dilated Cardiomyopathy primitive and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values. Receives: Device: Echography; Device: Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial diastolic stiffness UltrafastEcho (kPa)
Normal values and intra-observer variability and inter-observer variability to demonstrate that the Aixplorer® myocardial elastography provides a reproducible assessment of myocardial stiffness.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies 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
- 120 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
- NCT02619825
- Sponsor's protocol ID
- 2014-03
- Status last verified
- Oct 2017
- First submitted
- 23 Oct 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
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 Pediatric Cardiology Under
- ClinicalTrials.gov ID
- NCT02619825
- Acronym / sponsor ID
- 2014-03
- Keywords
- Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 2 Dec 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.
First, investigators must determine the physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness [VD] and left ventricular [LV]). This will be done in groups of children without heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]).
Secondly, investigators will evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with cardiomyopathy and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values. The total population of the study will be 120 children (40 healthy, 80 patients).
Detailed description
Monocenter Prospective, open-label, non-randomized. All patients included in the study have a specific consultation built around a clinical examination and echocardiography, in two stages, with estimates of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measures of all echocardiographic parameters estimated in children with a clinical ultrasound machine (Philips and General Electric).
Following this consultation, clinic and electrocardiographic monitoring period will be observed for 30 minutes, to ensure the safety of our procedure.
Required subjects: 40 healthy volunteers + 80 = 120 persons
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 "healthy volunteers | Other | Device: Echography, Device: ElastographyEchography and Elastography To determine physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness [VD] and left ventricular [LV]). This will be done in groups of children without heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]). |
| Group 2 Patients CMH primitive | Other | Device: Echography, Device: ElastographyEchography and Elastography To evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with Hypertrophic Cardiomyopathy (HCM) non obstructive primitive and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values. |
| Group 3 Patients primitive CMD: | Other | Device: Echography, Device: ElastographyEchography and Elastography To evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with Dilated Cardiomyopathy primitive and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values. |
Who may qualify
- Ages
- 1 day to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Group 1. Healthy Age criteria met by group [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]
- consultation for heart murmur
- Recipient of a social protection scheme or entitled (excluding AME)
- Signed informed consent by the holders of parental authority
- Age criteria met by group [1 month-1 year 1 year-5 years]
Key exclusion criteria (17 listed)
- Age> 15 years
- Heart and Systemic Pathology identified
- metabolic and tissue pathology.
- known genetic pathology may have cardiac involvement.
- No echogenicity,
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 |
|---|---|---|
| Echographycardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measurement of all echocardiographic parameters estimated in children with a clinical ultrasound Machine | Device | Group 1 "healthy volunteers, Group 2 Patients CMH primitive, Group 3 Patients primitive CMD: |
| Elastographycardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and | Device | Group 1 "healthy volunteers, Group 2 Patients CMH primitive, Group 3 Patients primitive CMD: |
Primary outcome
Myocardial diastolic stiffness UltrafastEcho (kPa)
Time frame: through study completion, an average of 1 year
Normal values and intra-observer variability and inter-observer variability to demonstrate that the Aixplorer® myocardial elastography provides a reproducible assessment of myocardial stiffness.
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.
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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 Echography and Elastography in people with Dilated Cardiomyopathy and Hypertrophic Cardiomyopathy, 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 14 inclusion and 17 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 diastolic stiffness UltrafastEcho (kPa) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.