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

NCT05118152 | Completed

• 1 other identifier: RECHMPL21_0289
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

univentricular heart; Paediatric cardiology; cardiopulmonary exercise test; 3D echocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Association between 3D echocardiography and clinical data collected

  day 1

• Association between 3D echocardiography and quality of life data usually collected

  day 1

• ssociation between 3D echocardiography and 2D echocardiography data usually collected

  day 1

• Association between 3D echocardiography and blood test data usually collected.

  day 1

• Association between 3D echocardiography and MRI data usually collected.

  day 1

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a single ventricle or univentricular heart

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• University Hospital, Bordeaux: collaborator

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 36966111 BACKGROUND

MeSH Terms

Conditions

Univentricular Heart; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pascal AMEDRO, MD-PhD

  UH MONTPELLIER

  STUDY DIRECTOR

• Valentin FEMENIA, resident

  UH MONTPELLIER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: November 11, 2021
• Study Start: June 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

FR (1)