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Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle

NCT05118152 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2023-10-27

No results posted yet for this study

Summary

Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Among CHD, univentricular heart disease or "single ventricle" is rare and complex. As a result of the improved patient care over the last decades, the number of children and adults with single ventricle is increasing significantly. Today, the main challenge is to ensure an optimal follow-up of these new patients in order to improve their life expenctancy as well as their quality of life (QoL). Currently, echocardiography and cardiopulmonary exercice test (CPET) are central in management of patients with single ventricle as part of good clinical practice guidelines.

Single ventricle volumes and function are very difficult to asses with conventional echocardiography because of their complex geometry. Indeed, single ventricle size and morphology vary depending on the patient characteristics and on the initial CHD (before surgical repair). That's why conventional 2D echocardiographic parameters are not reliable for single ventricle assessment.

Magnetic resonance imaging (MRI) is more effective in assessing single ventricle volumes and function. Nevertheless, MRI is not universally available, is not practical in many situations, is expensive, and is a relative contraindication in patients with pacemakers.

Over the past decade, the use of the 3D echocardiography has increased. This is an available tool that can assess ventricular function and volumes in few seconds. Recent studies shown a good correlation between 3D echocardiography and MRI for assessment of ventricular volumes and function in patient with CHD and especially in those with single ventricle.

Moreover, according to some authors, CPET parameters are strongly correlated with risk of hospitalization, risk of death, physical activity and quality of life, especially in patients with single ventricle.

To date, there is no study performed about the relationship between 3D echocardiography and CPET parameters in patients with single ventricle.

Conditions

  • Single-ventricle
  • Congenital Heart Disease

Sponsors & Collaborators

  • University Hospital, Bordeaux

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Pascal AMEDRO, MD-PhD · UH MONTPELLIER

  • Valentin FEMENIA, resident · UH MONTPELLIER

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05118152 on ClinicalTrials.gov