Congenital Heart DiseaseFollow-HeartNCT04815577
Evolution of Cardiopulmonary Fitness in Children With Congenital Heart Disease
An observational study of Congenital Heart Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
With an incidence of 0.8 %, congenital heart disease (CHD) is the leading cause of congenital anomalies at birth. Medical advances in CHD have transferred the mortality from childhood to adulthood and today there are more adults with CHD than children. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 20 Feb 2021
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: * Children with congenital heart disease with 2 CPET separated at least by 1 year * Controlled children with completely normal check-up, including physical examination, ECG, echocardiography and spirometry
Who may be able to join
- children with CHD included in the first study carried out from 2010 to 2015 6 and who have had at least 1 CPET 1 year after the first.
- children referred for a nonsevere functional symptom linked to exercise (murmur, palpitation or dyspnoea) or for a medical sports certificate.
- completely normal check-up, including physical examination, ECG, echocardiography and spirometry.
Who cannot join
- Children with any chronic disease, medical condition (cardiac, neurological, respiratory, muscular or renal)
- Children with any medical treatment
- Children requiring any further specialised medical consultation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Cardiopulmonary Fitness in Children With Congenital Heart Disease : a Longitudinal Multi-center Study
With an incidence of 0.8 %, congenital heart disease (CHD) is the leading cause of congenital anomalies at birth. Medical advances in CHD have transferred the mortality from childhood to adulthood and today there are more adults with CHD than children. After focusing on survival, more attention is being given to health-related quality of life and secondary prevention in this population where warning signals are launched on the risk of sedentary lifestyle, obesity, cardiovascular risk 1.
The cardiopulmonary exercise test (CPET), which is a non-invasive and dynamic examination, is becoming the gold standard to the follow-up 2 of these patients by allowing to quantify disease severity, to evaluate the quality of life 3, to give important prognostic information on functional capacity and haemodynamic response 4, to facilitate a safe decision-making when prescribing exercise programmes and sport participation for these children with CHD 5.
Read more
In this context, in a cross-sectional study from 2010 to 2015, the investigators evaluated the cardiopulmonary fitness of children with CHD by comparing them with healthy children 6. In this study, 496 children with CHD compared to 302 healthy children were included. It showed that maximum oxygen uptake (VO2max) and ventilatory anaerobic threshold (VAT) are decreased in CHD children compared to healthy children, clinical determinants of decreased VO2max have been defined for CHD children. This study was proposed, despite the cross-sectional nature, an average decrease in annual VO2max (0,84 ml/kg/min per year) to make pediatric and congenital cardiologist aware of the need to a regular follow up for these patients.
In this new study, the main objective was to know the real evolution of VO2max in these patients from this same cohort, with a longitudinal design, by collecting a new CPET carried out between 2015 and 2020 and compared these results to healthy pediatric population.
The secondary objectives were: to know the evolution of the VAT, to define the clinical determinants in relation to the annual decrease of the VO2max. And to describe the population lost to follow-up in this retrospective study which represents current practice.
Read the detailed description
Longitudinal multi-center study from November 2010 to September 2020 in two pediatric CPET laboratories (center 1: M3C Regional Pediatric and Congenital Cardiology Centre, Montpellier University Hospital, France; center 2: Pediatric Cardiology and Rehabilitation Centre, Institut-Saint-Pierre, Palavas-Les-Flots, France).
Two groups will be identify: CHD group and control group. The CHD group is made up of the children included in the first study6. From these 496 children with CHD, children with a second CPET more than one year from the first referral CPET were included. If several CPETs were performed in the follow-up, we retain the most distant CPET from the first. The patients included in the initial study were aged 5-18 years old and they were referred by their paediatric cardiologists to one of the two CPET laboratories after their annual medical check-up.
The control group consisted of children referred for a nonsevere functional symptom linked to exercise (murmur, palpitation or dyspnoea) or for a medical sports certificate. These children were classified in the control group only after a completely normal check-up, including physical examination, ECG, echocardiography and spirometry. Children with any chronic disease, medical condition (cardiac, neurological, respiratory, muscular or renal), or medical treatment and those requiring any further specialised medical consultation were not eligible. We included controlled children from 2015-2020 period who will be added to the controlled patients of the initial study6. These patients only had one CPET.
The main objective was to describe the annual evolution in VO2max for patients with CHD compared to control children.
Secondary obectives were :
- describe the annual evolution of ventilatory anaerobic threshold (VAT) for patients with CHD compared to control children.
- define the clinical determinants in relation to the annual decrease of the VO2 max.
- describe the population lost to follow-up in this retrospective study which represents current practice
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, VO2max, Cardio-pulmonary exercise test
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CHD group | The CHD group is made up of the children included in the first study. From these 496 children with CHD, children with a second CPET more than one year from the first referral CPET were included. If several CPETs were performed in the follow-up, we retain the most distant CPET from the first, excluding the CPETs that were performed after a cardiopulmonary rehabilitation program implemented in the region in 2018. The group corresponding to the first CPET was called. Among the initial 496 children, if patients had not had a second CPET, the cause was indicated. As a reminder, the patients included in the initial study were aged 5-18 years old and they were referred by their paediatric cardiologists to one of the two CPET laboratories after their annual medical check-up. The anatomical and clinical classification of congenital heart diseases was used to define the type of malformation. The demographic, clinical, echocardiographic data were collected during the first CPET. | |
| Controle | The controle Group consisted of children referred for nonsevere functional symptom linked to exercise (murmur, palpitations or dyspnea) or for a medical sports certificate. We included controlled children from 2015 to 2020 period who will be added to the controlled patients of the initial study. These patients only had one CPET. |
What is being measured
The primary outcome is the main question the study is designed to answer.
to give the annual evolution in VO2max for patients with CHD compared to control children
comparison of the VO2max value in ml/kg/min between point 1 and point 2 (greater than 1 year) and report the value per year. These results will be compared to evolution of VO2max in controlled children.
Measured: more than 1 year (maximum 8 years)
Secondary outcomes (3)
to give the annual evolution in VAT for patients with CHD compared to control children
comparison of the VAT value in ml/kg/min between point 1 and point 2 (greater than 1 year) and report the value per year. These results will be compared to evolution of VO2max in controlled children.
Measured: more than 1 year (maximum 8 years)
correlation between clinical determinants and annual decrease of the VO2 max in the CHD group
with multivariate analysis, we will look for the correlation between the clinical determinants (collected during the first CPET) and the annual decreased of VO2max in CHD group.
Measured: more than 1 year (maximum 8 years)
description of the population lost to follow-up in this retrospective study which represents current practice
description of demographic data and severity of CHD
Measured: more than 1 year (maximum 8 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Mar 2020
- Primary completion1 Feb 2021
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies 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
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur GAVOTTO, MD, Principal investigator, University Hospital, MontpellierPascal AMEDRO, MD, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815577
- Sponsor's protocol ID
- RECHMPL19_0476
- Acronym
- Follow-Heart
- Status last verified
- Oct 2023
- First submitted
- 22 Mar 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
Amedro P, Mura T, Matecki S, Guillaumont S, Requirand A, Jeandel C, Kollen L, Gavotto A. Use of new paediatric VO2max reference equations to evaluate aerobic fitness in overweight or obese children with congenital heart disease. Eur J Prev Cardiol. 2023 Nov 30;30(17):1865-1873. doi: 10.1093/eurjpc/zwad201.
PubMed 37314435Gavotto A, Ladeveze M, Avesani M, Huguet H, Guillaumont S, Picot MC, Requirand A, Matecki S, Amedro P. Aerobic fitness change with time in children with congenital heart disease: A retrospective controlled cohort study. Int J Cardiol. 2023 Jan 15;371:140-146. doi: 10.1016/j.ijcard.2022.09.068. Epub 2022 Sep 29.
PubMed 36181952
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
- Evolution of Cardiopulmonary Fitness in Children With Congenital Heart Disease : a Longitudinal Multi-center Study
- ClinicalTrials.gov ID
- NCT04815577
- Acronym / sponsor ID
- Follow-Heart / RECHMPL19_0476
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, VO2max, Cardio-pulmonary exercise test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 25 Mar 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.
With an incidence of 0.8 %, congenital heart disease (CHD) is the leading cause of congenital anomalies at birth. Medical advances in CHD have transferred the mortality from childhood to adulthood and today there are more adults with CHD than children. After focusing on survival, more attention is being given to health-related quality of life and secondary prevention in this population where warning signals are launched on the risk of sedentary lifestyle, obesity, cardiovascular risk 1.
The cardiopulmonary exercise test (CPET), which is a non-invasive and dynamic examination, is becoming the gold standard to the follow-up 2 of these patients by allowing to quantify disease severity, to evaluate the quality of life 3, to give important prognostic information on functional capacity and haemodynamic response 4, to facilitate a safe decision-making when prescribing exercise programmes and sport participation for these children with CHD 5.
In this context, in a cross-sectional study from 2010 to 2015, the investigators evaluated the cardiopulmonary fitness of children with CHD by comparing them with healthy children 6. In this study, 496 children with CHD compared to 302 healthy children were included. It showed that maximum oxygen uptake (VO2max) and ventilatory anaerobic threshold (VAT) are decreased in CHD children compared to healthy children, clinical determinants of decreased VO2max have been defined for CHD children. This study was proposed, despite the cross-sectional nature, an average decrease in annual VO2max (0,84 ml/kg/min per year) to make pediatric and congenital cardiologist aware of the need to a regular follow up for these patients.
In this new study, the main objective was to know the real evolution of VO2max in these patients from this same cohort, with a longitudinal design, by collecting a new CPET carried out between 2015 and 2020 and compared these results to healthy pediatric population.
The secondary objectives were: to know the evolution of the VAT, to define the clinical determinants in relation to the annual decrease of the VO2max. And to describe the population lost to follow-up in this retrospective study which represents current practice.
Detailed description
Longitudinal multi-center study from November 2010 to September 2020 in two pediatric CPET laboratories (center 1: M3C Regional Pediatric and Congenital Cardiology Centre, Montpellier University Hospital, France; center 2: Pediatric Cardiology and Rehabilitation Centre, Institut-Saint-Pierre, Palavas-Les-Flots, France).
Two groups will be identify: CHD group and control group. The CHD group is made up of the children included in the first study6. From these 496 children with CHD, children with a second CPET more than one year from the first referral CPET were included. If several CPETs were performed in the follow-up, we retain the most distant CPET from the first. The patients included in the initial study were aged 5-18 years old and they were referred by their paediatric cardiologists to one of the two CPET laboratories after their annual medical check-up.
The control group consisted of children referred for a nonsevere functional symptom linked to exercise (murmur, palpitation or dyspnoea) or for a medical sports certificate. These children were classified in the control group only after a completely normal check-up, including physical examination, ECG, echocardiography and spirometry. Children with any chronic disease, medical condition (cardiac, neurological, respiratory, muscular or renal), or medical treatment and those requiring any further specialised medical consultation were not eligible. We included controlled children from 2015-2020 period who will be added to the controlled patients of the initial study6. These patients only had one CPET.
The main objective was to describe the annual evolution in VO2max for patients with CHD compared to control children.
Secondary obectives were :
- describe the annual evolution of ventilatory anaerobic threshold (VAT) for patients with CHD compared to control children.
- define the clinical determinants in relation to the annual decrease of the VO2 max.
- describe the population lost to follow-up in this retrospective study which represents current practice
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHD group | – | –The CHD group is made up of the children included in the first study. From these 496 children with CHD, children with a second CPET more than one year from the first referral CPET were included. If several CPETs were performed in the follow-up, we retain the most distant CPET from the first, excluding the CPETs that were performed after a cardiopulmonary rehabilitation program implemented in the region in 2018. The group corresponding to the first CPET was called. Among the initial 496 children, if patients had not had a second CPET, the cause was indicated. As a reminder, the patients included in the initial study were aged 5-18 years old and they were referred by their paediatric cardiologists to one of the two CPET laboratories after their annual medical check-up. The anatomical and clinical classification of congenital heart diseases was used to define the type of malformation. The demographic, clinical, echocardiographic data were collected during the first CPET. |
| Controle | – | –The controle Group consisted of children referred for nonsevere functional symptom linked to exercise (murmur, palpitations or dyspnea) or for a medical sports certificate. We included controlled children from 2015 to 2020 period who will be added to the controlled patients of the initial study. These patients only had one CPET. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- * Children with congenital heart disease with 2 CPET separated at least by 1 year * Controlled children with completely normal check-up, including physical examination, ECG, echocardiography and spirometry
Key inclusion criteria (3 listed)
- children with CHD included in the first study carried out from 2010 to 2015 6 and who have had at least 1 CPET 1 year after the first.
- children referred for a nonsevere functional symptom linked to exercise (murmur, palpitation or dyspnoea) or for a medical sports certificate.
- completely normal check-up, including physical examination, ECG, echocardiography and spirometry.
Key exclusion criteria (3 listed)
- Children with any chronic disease, medical condition (cardiac, neurological, respiratory, muscular or renal)
- Children with any medical treatment
- Children requiring any further specialised medical consultation
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
to give the annual evolution in VO2max for patients with CHD compared to control children
Time frame: more than 1 year (maximum 8 years)
comparison of the VO2max value in ml/kg/min between point 1 and point 2 (greater than 1 year) and report the value per year. These results will be compared to evolution of VO2max in controlled children.
3 secondary outcomes
to give the annual evolution in VAT for patients with CHD compared to control children
Time frame: more than 1 year (maximum 8 years)
correlation between clinical determinants and annual decrease of the VO2 max in the CHD group
Time frame: more than 1 year (maximum 8 years)
description of the population lost to follow-up in this retrospective study which represents current practice
Time frame: more than 1 year (maximum 8 years)
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 37314435Amedro P, Mura T, Matecki S, Guillaumont S, Requirand A, Jeandel C, Kollen L, Gavotto A. Use of new paediatric VO2max reference equations to evaluate aerobic fitness in overweight or obese children with congenital heart disease. Eur J Prev Cardiol. 2023 Nov 30;30(17):1865-1873. doi: 10.1093/eurjpc/zwad201.
- Derived from this study: PubMed 36181952Gavotto A, Ladeveze M, Avesani M, Huguet H, Guillaumont S, Picot MC, Requirand A, Matecki S, Amedro P. Aerobic fitness change with time in children with congenital heart disease: A retrospective controlled cohort study. Int J Cardiol. 2023 Jan 15;371:140-146. doi: 10.1016/j.ijcard.2022.09.068. Epub 2022 Sep 29.
- 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.
Arthur GAVOTTO, MD principal investigator
University Hospital, Montpellier
Pascal AMEDRO, MD, PhD study director
University Hospital, 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 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 3 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?
to give the annual evolution in VO2max for patients with CHD compared to control children (time frame: more than 1 year (maximum 8 years)). 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 NCT04815577, which also lists 2 linked publications.
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.