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Ultrafast Ultrasound Imaging in Pediatric Cardiology

NCT ID: NCT07255144

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-11

Study Completion Date

2028-03-11

Brief Summary

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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

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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

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CHD - Congenital Heart Disease

Keywords

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Congenital heart disease Paediatric Cardiac Imaging Ultrafast ultrasounf

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CHD

Patients with CHD

Cardiac Ultrafast Ultrasound

Intervention Type OTHER

Ultrafast ultrasound imaging(UFUS), ultrasound images at a very high rate, using a Verasonics system (ultrasound open platform).

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

Cardiac Ultrafast Ultrasound

Intervention Type OTHER

Ultrafast ultrasound imaging(UFUS), ultrasound images at a very high rate, using a Verasonics system (ultrasound open platform).

Interventions

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Cardiac Ultrafast Ultrasound

Ultrafast ultrasound imaging(UFUS), ultrasound images at a very high rate, using a Verasonics system (ultrasound open platform).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Arrhythmia
* Segmental kinetic disorder.
* Pacemaker or multisite stimulation, defibrillator,
* Anechoic
* Allergy to echocardiography gel.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Cardiologique Haut Lévêque

Pessac, France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Olivier VILLEMAIN, MD, PhD

Role: CONTACT

Phone: +33 5 24 54 94 79

Email: [email protected]

Facility Contacts

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Olivier VILLEMAIN, MD,PhD

Role: primary

Other Identifiers

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CER-BDX 2024-169

Identifier Type: OTHER

Identifier Source: secondary_id

CHUBX 2024/52

Identifier Type: -

Identifier Source: org_study_id