Single-ventricleVU3DNCT05118152
Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle
An observational study of Single-ventricle and Congenital Heart Disease, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Single-ventricle, Congenital Heart Disease
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with a single ventricle or univentricular heart
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Single-ventricle, Congenital Heart Disease
- Keywords
- univentricular heart, Paediatric cardiology, cardiopulmonary exercise test, 3D echocardiography
- Medical subject headings
- Univentricular Heart, Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: day 1
Secondary outcomes (6)
Association between 3D echocardiography and clinical data collected
Association between 3D echocardiography and clinical data collected in usual medical check-up.
Measured: day 1
Association between 3D echocardiography and quality of life data usually collected
Association between 3D echocardiography and quality of life data usually collected.
Measured: day 1
ssociation between 3D echocardiography and 2D echocardiography data usually collected
Association between 3D echocardiography and 2D echocardiography data usually collected.
Measured: day 1
Association between 3D echocardiography and blood test data usually collected.
Association between 3D echocardiography and blood test data usually collected.
Measured: day 1
Association between 3D echocardiography and MRI data usually collected.
Association between 3D echocardiography and MRI data usually collected.
Measured: day 1
Assessment of 3D echocardiography interobserver and intraobserver variability
Assessment of 3D echocardiography interobserver and intraobserver variability.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Jun 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Single-ventricleStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD-PhD, Study director, UH MONTPELLIERValentin FEMENIA, resident, Principal investigator, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118152
- Sponsor's protocol ID
- RECHMPL21_0289
- Acronym
- VU3D
- Status last verified
- Oct 2023
- First submitted
- 19 Jul 2021
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
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.
PubMed 36966111
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle: A Cross-sectional Observational Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT05118152
- Acronym / sponsor ID
- VU3D / RECHMPL21_0289
- Conditions
- Single-ventricle, Congenital Heart Disease
- Keywords
- univentricular heart, Paediatric cardiology, cardiopulmonary exercise test, 3D echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a single ventricle or univentricular heart
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between single ventricle volumes and function parameters in 3D echocardiography
Time frame: day 1
Association between single ventricle volumes and function parameters in 3D echocardiography (End-diastolic volume, End-systolic volume, Stroke volume)
6 secondary outcomes
Association between 3D echocardiography and clinical data collected
Time frame: day 1
Association between 3D echocardiography and quality of life data usually collected
Time frame: day 1
ssociation between 3D echocardiography and 2D echocardiography data usually collected
Time frame: day 1
Association between 3D echocardiography and blood test data usually collected.
Time frame: day 1
Association between 3D echocardiography and MRI data usually collected.
Time frame: day 1
Assessment of 3D echocardiography interobserver and intraobserver variability
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Background: PubMed 36966111Femenia 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.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal AMEDRO, MD-PhD study director
UH MONTPELLIER
Valentin FEMENIA, resident principal investigator
UH MONTPELLIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single-ventricle and Congenital Heart Disease, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between single ventricle volumes and function parameters in 3D echocardiography (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05118152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.