NCT07255144

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Mar 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Mar 2025Mar 2028

Study Start

First participant enrolled

March 11, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2028

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

November 19, 2025

Last Update Submit

November 19, 2025

Conditions

CHD - Congenital Heart Disease

Keywords

Congenital heart diseasePaediatricCardiac ImagingUltrafast ultrasounf

Outcome Measures

Primary Outcomes (2)

  • Myocardial stiffness

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

    Baseline

  • Myocardial perfusion

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

    Baseline

Secondary Outcomes (1)

  • Echocardiographic parameters

    Baseline

Study Arms (2)

CHD

Patients with CHD

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

Other: Cardiac Ultrafast Ultrasound

Interventions

Cardiac Ultrafast UltrasoundOTHER

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

CHDGeneral population

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cardiologique Haut Lévêque

Pessac, France, 33604, France

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Olivier VILLEMAIN, MD, PhD

CONTACT

+33 5 24 54 94 79olivier.villemain@chu-bordeaux.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 28, 2025

Study Start

March 11, 2025

Primary Completion (Estimated)

March 11, 2028

Study Completion (Estimated)

March 11, 2028

Last Updated

November 28, 2025

Record last verified: 2025-11

Locations

FR(1)