NCT05118152: VU3D

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

Completed Last updated 27 October 2023

What this trial tests

trial in Single-ventricle in 33 participants. Completed in 30 June 2022.

Timeline

1 June 2021

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	University Hospital, Montpellier
Status	Completed
Study type	OBSERVATIONAL
Enrollment	33
Start date	1 June 2021
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	1 location across France

Conditions studied

• Single-ventricle — all drugs for Single-ventricle →
• Congenital Heart Disease — all drugs for Congenital Heart Disease →

Sponsor

University Hospital, Montpellier

Who can join

8 and older, any sex, with Single-ventricle or Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.