Univentricular HeartSVNCT04026542
Factors Associated With Normal Exercise Capacity in Patients With Single Ventricle
An observational study of Univentricular Heart, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The congenital heart disease (CHD) is the firts cause of congenital birth defects. Medical and surgical advances completely changed the epidemiology of CHD. Among these CHD, the univentricular heart, or single ventricle (SV), is a disease whose medical-surgical progress has completely changed the epidemiology. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Univentricular Heart
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2019to 31 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a single ventricle according to the international classification ACC-CHD who had a cardiopulmonary exercise test in the year during usual follow-up.
Who may be able to join
- Children ≥ 6 years old and adults with a single ventricle according to the international classification ACC-CHD and who had a cardiopulmonary exercise test in the year during usual follow-up.
Who cannot join
- Patients refuse the use of medical data will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Associated With Normal Exercise Capacity in Patients With Single Ventricle: the Multicenter Cross-sectional Study
The congenital heart disease (CHD) is the firts cause of congenital birth defects. Medical and surgical advances completely changed the epidemiology of CHD. Among these CHD, the univentricular heart, or single ventricle (SV), is a disease whose medical-surgical progress has completely changed the epidemiology.
The SV at birth receives systemic and pulmonary venous returns in the single functional cavity and provides systemic and pulmonary flow. The SV undergoes a severe volumetric overload and considerably increases its work, which is not viable for the long time.
Read more
In 1968, Professor Francis Fontan created the palliative surgery of the univentricular heart. It consists in establishing a derivation of the systemic venous blood from the two vena cava veins directly to the pulmonary arteries, without a sub-pulmonary ventricle. So, the VU no longer undergoes volumetric overload, and eliminates cyanosis.
In this "Fontan circulation", there is no pump to push the blood in the pulmonary arteries, only the remaining systemic post-capillary energy (reflection of the central venous pressure) allows to drive the blood through the lungs with a risk of stasis upstream (right overload) and a limited pre-charge downstream, which can lead to severe consequences: limited exercise capacity, systolic and diastolic dysfunction of the SV, arrhythmia, cyanosis, cirrhosis and hepatic carcinoma, exudative enteropathy , plastic bronchitis, venous thromboses, deaths.
There is a great heterogeneity within this family of SV with extremely varied evolutionary profiles. The cardiorespiratory exercise test, which has become a "gold standard", makes it possible to assess the severity of CHD. In our study on the aerobic fitness of children with CHD, the investigators found that 44% of children with SV had normal aerobic fitness (> 80% of the theoretical VO2max)1. Some good prognostic criteria are already described: left SV, good VU function, total cavopulmonary shunt in young age, etc. But the investigators know that these elements are not enough to explain why some SV, which the investigators will call the "great-SV", have a better aerobic fitness.
The main objective of our study is to describe the population of "great SV" (VO2max ≥ 80%) within the general population of SV. The investigators thus wish to determine the prognostic criteria favorable to a good aerobic fitness in univenticular heart disease.
Read the detailed description
This study is cross-sectionnal, multicentric national (M3C network), descriptive, observational.
Children ≥ 6 years old and adults with a single ventricle according to the international classification ACC-CHD and who had a cardiopulmonary exercise test in the year during usual follow-up will be included. Patients refuse the use of medical data will be excluded.
The main objective of our study is to describe the rate of "great SV" (VO2max ≥ 80%) within the general population of SV. The secondary objectives are to compare the two groups: group "great SV" with VO2max ≥ 80% versus group SV with VO2max < 80%.
The following criteria will be collected
Anatomical : left SV, right SV, undetermined SV, total cavopulmoary shunt, partial cavopulmonary shunt
Clinic: NYHA status, saturation, medical treatment, number of surgery procedure, number of catheterization procedure, presence of pacemaker or implantable defibrillator, presence of arrythmia.
Morbidity: number oh hospitalization during the year, presence of arrhythmia, cirrhosis and hepatic carcinoma, exudative enteropathy , plastic bronchitis, venous thromboses, stroke.
Echocardiography: ejection fraction of SV, 2D Strain of SV, atrioventricular valve regurgitation, aortic stenosis, aspect of the flow in the cavopulmonary shunt.
Cardiac MRI: ejection fraction of SV
Cardiac catheterization: mean pulmonary arterial pressure, pulmonary arterial wedge pressure, presence of fistulae.
Cardiopulmonary exercise test : VO2max, anaerobic threesold, VE/VCO2 slope, oxygen uptake efficiciency slope, maximal heart rate, oxygene pulse and saturation at exercise.
Pulmonary functional test : forced expiratory volume in 1 seconde (FEV1), the forced vital capacity (FVC), the FEV1/FVC ratio (FEV1/FVC%), DLCO and residual volume.
- Conditions
- Univentricular Heart
- Keywords
- VO2max, Fontan, Congenital heart disease, Single ventricle
- 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.
rate of "great SV" (VO2max ≥ 80%) within the general population of SV
- measurement of the VO2max at the annual cardiopulmonary exercise test.
- rate of patient who have a VO2max ≥ 80% in this population of SV recruited.
Measured: 1 day
Secondary outcomes (1)
Comparison of the 2 groups: "great SV" versus others SV.
Multivariate analysis with the following data to define parameters associated with "great SV": Anatomical, Clinic, Morbidity, Echocardiography, Cardiac MRI, Cardiac catheterization, Cardiopulmonary exercise test, Pulmonary functional test
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Sep 2019
- Primary completion1 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Univentricular HeartStudies of the same condition, open and under way.
- 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- M3C (complex congenital heart disease) French Network
- 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
- NCT04026542
- Sponsor's protocol ID
- RECHMPL19_0330
- Acronym
- SV
- Status last verified
- Mar 2020
- First submitted
- 17 Jul 2019
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Normal Exercise Capacity in Patients With Single Ventricle: the Multicenter Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04026542
- Acronym / sponsor ID
- SV / RECHMPL19_0330
- Conditions
- Univentricular Heart
- Keywords
- VO2max, Fontan, Congenital heart disease, Single ventricle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- M3C (complex congenital heart disease) French Network
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Jul 2019 (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.
The congenital heart disease (CHD) is the firts cause of congenital birth defects. Medical and surgical advances completely changed the epidemiology of CHD. Among these CHD, the univentricular heart, or single ventricle (SV), is a disease whose medical-surgical progress has completely changed the epidemiology.
The SV at birth receives systemic and pulmonary venous returns in the single functional cavity and provides systemic and pulmonary flow. The SV undergoes a severe volumetric overload and considerably increases its work, which is not viable for the long time.
In 1968, Professor Francis Fontan created the palliative surgery of the univentricular heart. It consists in establishing a derivation of the systemic venous blood from the two vena cava veins directly to the pulmonary arteries, without a sub-pulmonary ventricle. So, the VU no longer undergoes volumetric overload, and eliminates cyanosis.
In this "Fontan circulation", there is no pump to push the blood in the pulmonary arteries, only the remaining systemic post-capillary energy (reflection of the central venous pressure) allows to drive the blood through the lungs with a risk of stasis upstream (right overload) and a limited pre-charge downstream, which can lead to severe consequences: limited exercise capacity, systolic and diastolic dysfunction of the SV, arrhythmia, cyanosis, cirrhosis and hepatic carcinoma, exudative enteropathy , plastic bronchitis, venous thromboses, deaths.
There is a great heterogeneity within this family of SV with extremely varied evolutionary profiles. The cardiorespiratory exercise test, which has become a "gold standard", makes it possible to assess the severity of CHD. In our study on the aerobic fitness of children with CHD, the investigators found that 44% of children with SV had normal aerobic fitness (> 80% of the theoretical VO2max)1. Some good prognostic criteria are already described: left SV, good VU function, total cavopulmonary shunt in young age, etc. But the investigators know that these elements are not enough to explain why some SV, which the investigators will call the "great-SV", have a better aerobic fitness.
The main objective of our study is to describe the population of "great SV" (VO2max ≥ 80%) within the general population of SV. The investigators thus wish to determine the prognostic criteria favorable to a good aerobic fitness in univenticular heart disease.
Detailed description
This study is cross-sectionnal, multicentric national (M3C network), descriptive, observational.
Children ≥ 6 years old and adults with a single ventricle according to the international classification ACC-CHD and who had a cardiopulmonary exercise test in the year during usual follow-up will be included. Patients refuse the use of medical data will be excluded.
The main objective of our study is to describe the rate of "great SV" (VO2max ≥ 80%) within the general population of SV. The secondary objectives are to compare the two groups: group "great SV" with VO2max ≥ 80% versus group SV with VO2max < 80%.
The following criteria will be collected
Anatomical : left SV, right SV, undetermined SV, total cavopulmoary shunt, partial cavopulmonary shunt
Clinic: NYHA status, saturation, medical treatment, number of surgery procedure, number of catheterization procedure, presence of pacemaker or implantable defibrillator, presence of arrythmia.
Morbidity: number oh hospitalization during the year, presence of arrhythmia, cirrhosis and hepatic carcinoma, exudative enteropathy , plastic bronchitis, venous thromboses, stroke.
Echocardiography: ejection fraction of SV, 2D Strain of SV, atrioventricular valve regurgitation, aortic stenosis, aspect of the flow in the cavopulmonary shunt.
Cardiac MRI: ejection fraction of SV
Cardiac catheterization: mean pulmonary arterial pressure, pulmonary arterial wedge pressure, presence of fistulae.
Cardiopulmonary exercise test : VO2max, anaerobic threesold, VE/VCO2 slope, oxygen uptake efficiciency slope, maximal heart rate, oxygene pulse and saturation at exercise.
Pulmonary functional test : forced expiratory volume in 1 seconde (FEV1), the forced vital capacity (FVC), the FEV1/FVC ratio (FEV1/FVC%), DLCO and residual volume.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a single ventricle according to the international classification ACC-CHD who had a cardiopulmonary exercise test in the year during usual follow-up.
Key inclusion criteria (1 listed)
- Children ≥ 6 years old and adults with a single ventricle according to the international classification ACC-CHD and who had a cardiopulmonary exercise test in the year during usual follow-up.
Key exclusion criteria (1 listed)
- Patients refuse the use of medical data will be excluded.
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
rate of "great SV" (VO2max ≥ 80%) within the general population of SV
Time frame: 1 day
* measurement of the VO2max at the annual cardiopulmonary exercise test. * rate of patient who have a VO2max ≥ 80% in this population of SV recruited.
1 secondary outcome
Comparison of the 2 groups: "great SV" versus others SV.
Time frame: 1 day
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 19 May 2021.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Univentricular Heart
RecruitingObservational study
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RecruitingPhase 3
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Hypoplastic Left Heart Syndrome, Single Ventricle
Enrolling by invitationObservational study
International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease
Congenital Heart Disease
Recruiting
Venous Compression in Fontan
Single-ventricle, Fontan Circulation
RecruitingObservational study
PRecision Integrated Saturation Monitor
CHD - Congenital Heart Disease, Single Ventricle Heart Disease
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 Univentricular Heart, 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 1 inclusion and 1 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 19 May 2021. 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?
rate of "great SV" (VO2max ≥ 80%) within the general population of SV (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2021.