CHD - Congenital Heart DiseaseNCT07255144
Ultrafast Ultrasound Imaging in Pediatric Cardiology
An observational study of CHD - Congenital Heart Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
About 13 in 1000 children are born with heart disease. Current tools poorly assess heart filling in children, limiting treatment. This study explores ultrafast ultrasound imaging to measure heart stiffness and perfusion in children with congenital heart disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CHD - Congenital Heart Disease
- What is being tested?
- Cardiac Ultrafast Ultrasound
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2025to 11 Mar 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Every patient of CHD department of any age or any sex: 300 participants including 100 general population patients and 200 patients with CHD
Who may be able to join
- Every patient of CHD department of any age or any sex:
- Patients with CHD
- General population patients in good general health as evidenced by medical history coming to our department for a check-up OR diagnosed with small Atrial Septal Defect or small Patent Foramen Ovale
- Social security affiliation
- Parental or legal guardian's non-opposition
Who cannot join
- Arrhythmia
- Segmental kinetic disorder.
- Pacemaker or multisite stimulation, defibrillator,
- Anechoic
- Allergy to echocardiography gel.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Cardiologique Haut Lévêque
Pessac, France, 33604
Olivier VILLEMAIN, MD,PhD, +33 5 24 54 94 79 ext. +33, olivier.villemain@chu-bordeaux.fr
About this study
Official title: Ultrafast Ultrasound Imaging: Application in Pediatric Cardiology: Cardiac Ultrafast
About 13 in 1000 children are born with heart disease. Current tools poorly assess heart filling in children, limiting treatment. This study explores ultrafast ultrasound imaging to measure heart stiffness and perfusion in children with congenital heart disease.
Read the detailed description
About 13/1000 children are born with heart disease. As a result of better treatment, there is an increasing population of children surviving with congenital heart disease (CHD) as well as a growing number of children with obesity, hypertension and serious chronic diseases, such as cancer and kidney disease, who are at risk of developing heart disease. All of these diseases affect the heart muscle and one of the main mechanisms resulting in heart muscle damage is the development of scar tissue (fibrosis). Fibrosis makes the heart muscle stiffer and therefore more difficult to fill. The heart must fill properly with blood in order to function well; but it is very difficult to study the filling of the heart using current diagnostic tools. One of the main challenges in pediatric cardiology is that non-invasive diagnostic approaches used in adult patients to assess heart filling (diastolic function) have proven inadequate in children. This knowledge gap has limited therapeutic progress in this vulnerable population; and to date there is no effective therapy that improves the filling of the heart.
The aim of this study is to explore new potential of ultrasound to assess diastolic function in CHD children. Ultrafast ultrasound imaging (UFUS), consisting of ultrasound images at a very high rate, is a new ultrasound approach to assess cardiac function.
Using a Verasonics system (ultrasound open platform), we will assess the myocardial stiffness and the myocardial perfusion by UFUS.
- Conditions
- CHD - Congenital Heart Disease
- Being tested
- Cardiac Ultrafast Ultrasound
- Keywords
- Congenital heart disease, Paediatric, Cardiac Imaging, Ultrafast ultrasounf
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Ultrafast UltrasoundOther
Ultrafast ultrasound imaging(UFUS), ultrasound images at a very high rate, using a Verasonics system (ultrasound open platform).
| Study group | Role | What they receive |
|---|---|---|
| CHD | Patients with CHD Receives: Other: Cardiac Ultrafast Ultrasound | |
| General population | General population patients in good general health as evidenced by medical history coming to our department for a check-up OR diagnosed with small Atrial Septal Defect or small Patent Foramen Ovale Receives: Other: Cardiac Ultrafast Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial stiffness
assessed with ultrasound data processed using the Verasonics system, to evaluate diastolic function
Measured: Baseline
Myocardial perfusion
assessed with ultrasound data processed using the Verasonics system, to evaluate diastolic function
Measured: Baseline
Secondary outcomes (1)
Echocardiographic parameters
- Echocardiographic parameters according to international guidelines for screening for structural or functional intra-cardiac abnormalities (Lopez et al. JASE. 2024) and assessed by conventional ultrasound and ultrafast ultrasound.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start11 Mar 2025
- Primary completion11 Mar 2028 (estimated)
- Study completion11 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHD - Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255144
- Sponsor's protocol ID
- CHUBX 2024/52
- Other IDs
- CER-BDX 2024-169
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrafast Ultrasound Imaging: Application in Pediatric Cardiology: Cardiac Ultrafast
- ClinicalTrials.gov ID
- NCT07255144
- Acronym / sponsor ID
- CHUBX 2024/52
- Conditions
- CHD - Congenital Heart Disease
- Keywords
- Congenital heart disease, Paediatric, Cardiac Imaging, Ultrafast ultrasounf
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 11 Mar 2028 (estimated)
- Study completion
- 11 Mar 2028 (estimated)
- First posted
- 28 Nov 2025 (actual)
- 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.
About 13 in 1000 children are born with heart disease. Current tools poorly assess heart filling in children, limiting treatment. This study explores ultrafast ultrasound imaging to measure heart stiffness and perfusion in children with congenital heart disease.
Detailed description
About 13/1000 children are born with heart disease. As a result of better treatment, there is an increasing population of children surviving with congenital heart disease (CHD) as well as a growing number of children with obesity, hypertension and serious chronic diseases, such as cancer and kidney disease, who are at risk of developing heart disease. All of these diseases affect the heart muscle and one of the main mechanisms resulting in heart muscle damage is the development of scar tissue (fibrosis). Fibrosis makes the heart muscle stiffer and therefore more difficult to fill. The heart must fill properly with blood in order to function well; but it is very difficult to study the filling of the heart using current diagnostic tools. One of the main challenges in pediatric cardiology is that non-invasive diagnostic approaches used in adult patients to assess heart filling (diastolic function) have proven inadequate in children. This knowledge gap has limited therapeutic progress in this vulnerable population; and to date there is no effective therapy that improves the filling of the heart.
The aim of this study is to explore new potential of ultrasound to assess diastolic function in CHD children. Ultrafast ultrasound imaging (UFUS), consisting of ultrasound images at a very high rate, is a new ultrasound approach to assess cardiac function.
Using a Verasonics system (ultrasound open platform), we will assess the myocardial stiffness and the myocardial perfusion by UFUS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHD | – | Other: Cardiac Ultrafast UltrasoundPatients with CHD |
| General population | – | Other: Cardiac Ultrafast UltrasoundGeneral population patients in good general health as evidenced by medical history coming to our department for a check-up OR diagnosed with small Atrial Septal Defect or small Patent Foramen Ovale |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Every patient of CHD department of any age or any sex: 300 participants including 100 general population patients and 200 patients with CHD
Key inclusion criteria (5 listed)
- Every patient of CHD department of any age or any sex:
- Social security affiliation
- Parental or legal guardian's non-opposition
Key exclusion criteria (5 listed)
- Arrhythmia
- Segmental kinetic disorder.
- Pacemaker or multisite stimulation, defibrillator,
- Anechoic
- Allergy to echocardiography gel.
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 |
|---|---|---|
| Cardiac Ultrafast UltrasoundUltrafast ultrasound imaging(UFUS), ultrasound images at a very high rate, using a Verasonics system (ultrasound open platform). | Other | CHD, General population |
Primary outcome
Myocardial stiffness
Time frame: Baseline
assessed with ultrasound data processed using the Verasonics system, to evaluate diastolic function
Myocardial perfusion
Time frame: Baseline
assessed with ultrasound data processed using the Verasonics system, to evaluate diastolic function
1 secondary outcome
Echocardiographic parameters
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
Related trials for CHD - Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CHD - Congenital Heart Disease, run by University Hospital, Bordeaux 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier VILLEMAIN, MD, PhD (+33 5 24 54 94 79 ext. +33, olivier.villemain@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial stiffness (time frame: Baseline). The study lists 2 primary outcomes in all. 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 28 Nov 2025.