Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle (VU3D)

Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle: A Cross-sectional Observational Multicenter Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease; Single-ventricle

Detailed Description

This is a cross-sectional, observational, multicenter, and prospective study Eligible patients will be included during their usual medical check-up. As recommended by guidelines, patients with single ventricle have an 2D echocardiography and a CPET annualy. Data required for this study will be collected from patient medical record.

3D echography data acquisition will be performed using 2D ultrasound post-processing by TOMTEC software. No supplementary visit, directly related to the research, will be necessary. This study does not change the usual care management of the patient.

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

• Study Contact: Name: Pascal FEMENIA, MD-PhD; Phone Number: 04 67 33 66 43; Email: p-amedro@chu-montpellier.fr
• Study Contact Backup: Name: Valentin FEMENIA, resident; Phone Number: 33 467336632; Email: valentinfemenia@gmail.com

Study Locations

• France
  • Montpellier, France, 34295
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with a single ventricle or univentricular heart

Description

Inclusion criteria:

• Patient over 8 years old with univentricular heart disease as defined by the ACC-CHD classification
• Agreement from adults or parents if minor patients
• CPET performed within the 6 months before or after performing echocardiography

Exclusion criteria:

• Cardiomyopathy unrelated to CHD (eg coronary artery disease, toxic cardiomyopathy)
• Significant clinical status change between performing CPET and performing echocardiography, according to the investigator's opinion

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between single ventricle volumes and function parameters in 3D echocardiography	Association between single ventricle volumes and function parameters in 3D echocardiography (End-diastolic volume, End-systolic volume, Stroke volume)	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between 3D echocardiography and clinical data collected	Association between 3D echocardiography and clinical data collected in usual medical check-up.	day 1
Association between 3D echocardiography and quality of life data usually collected	Association between 3D echocardiography and quality of life data usually collected.	day 1
ssociation between 3D echocardiography and 2D echocardiography data usually collected	Association between 3D echocardiography and 2D echocardiography data usually collected.	day 1
Association between 3D echocardiography and blood test data usually collected.	Association between 3D echocardiography and blood test data usually collected.	day 1
Association between 3D echocardiography and MRI data usually collected.	Association between 3D echocardiography and MRI data usually collected.	day 1
Assessment of 3D echocardiography interobserver and intraobserver variability	Assessment of 3D echocardiography interobserver and intraobserver variability.	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: University Hospital, Bordeaux
• Investigators: Principal Investigator: Valentin FEMENIA, resident, UH Montpellier; Study Director: Pascal AMEDRO, MD-PhD, UH Montpellier

Publications and helpful links

General Publications

• Femenia V, Pommier V, Huguet H, Iriart X, Picot MC, Bredy C, Lorca L, De La Villeon G, Guillaumont S, Pasquie JL, Matecki S, Roubertie F, Leobon B, Thambo JB, Jalal Z, Thomas J, Mouton JB, Avesani M, Amedro P. Correlation between three-dimensional echocardiography and cardiopulmonary fitness in patients with univentricular heart: A cross-sectional multicentre prospective study. Arch Cardiovasc Dis. 2023 Apr;116(4):202-209. doi: 10.1016/j.acvd.2023.02.002. Epub 2023 Mar 9.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cardiopulmonary exercise test; univentricular heart; Paediatric cardiology; 3D echocardiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Univentricular Heart
• Other Study ID Numbers: RECHMPL21_0289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No