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NCT Number: NCT07255144

Ultrafast Ultrasound Imaging in Pediatric Cardiology

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Cardiologique Haut Lévêque

Pessac, France, 33604

Location status: Recruiting

Location contact

Olivier VILLEMAIN, MD,PhD

CONTACT

[email protected]

+33 5 24 54 94 79 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac Ultrafast Ultrasound

Other

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

Primary outcomes

  1. Myocardial stiffness

    Time frame: Baseline

    assessed with ultrasound data processed using the Verasonics system, to evaluate diastolic function

  2. Myocardial perfusion

    Time frame: Baseline

    assessed with ultrasound data processed using the Verasonics system, to evaluate diastolic function

Secondary outcomes

  1. Echocardiographic parameters

    Time frame: Baseline

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Olivier VILLEMAIN, MD, PhD

CONTACT

[email protected]

+33 5 24 54 94 79 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Ultrafast Ultrasound Imaging: Application in Pediatric Cardiology: Cardiac Ultrafast

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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