Congenital Heart DiseaseEPIDEMIO-CHDNCT04740177
Epidemiology of Congenital Heart Disease in France
An observational study of 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%. Since the 1980s, France has been a pioneer in neonatal CHD surgery (Pr. Fontan, Pr. Lecomte, Pr. Serraf, etc.), in prenatal diagnosis, and in interventional cardiac catheterization. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 450,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to 30 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with congenital heart disease (CHD)
Who may be able to join
- Patient (of any age) with a CHD as defined by the international ACC-CHD classification and listed in the ICD10 classification, hospitalized from 01/01/2010 to 12/31/2019 in a French tertiary care hospital from the M3C network.
Who cannot join
- Patient with non-malformative genetic heart disease (cardiomyopathy, hereditary rhythmic disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology of Congenital Heart Disease in France : EPIDEMIO-CHD
Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Since the 1980s, France has been a pioneer in neonatal CHD surgery (Pr. Fontan, Pr. Lecomte, Pr. Serraf, etc.), in prenatal diagnosis, and in interventional cardiac catheterization.
Actually, first children operated for complex CHD have reached adulthood and a new epidemiology of CHD is emerging. Currently, one of the public health challenges is the need to maintain appropriate follow-up and to avoid disruption of care during the transition from adolescence to adulthood. Thus, the national health authorities (DGOS) recently certified a national network of expert centers for complex CHD (M3C).
Read more
In addition, under the leadership of the French Society of Cardiology, the sub-specialty of Pediatric and Congenital Cardiology has been recognized.
However, while North American and North European countries have published their updated data on the main indicators of CHD morbidity and mortality, no study has reported epidemiology of CHD in France.
Currently, available data are approximate, estimating that 200,000 children and 250,000 adults would be living in France with a CHD. Nevertheless, no information is available on hospitalizations, type of CHD, their follow-up, possible disruption in care, and morbidity and mortality in patients with CHD in France. This epidemiological study will use the national health insurance hospital database to answer these questions.
Read the detailed description
Retrospective epidemiological study based on the national health insurance hospital database from 2010 to 2020 (10 years):
Main objective:
- To assess the prevalence of patients with CHD hospitalized in France over 10 years.
Secondary objectives: asess over the same period:
- Overall mortality rate according to the CHD classification and the geographic area
- Overall morbidity rate, according to the CHD classification and the geographic area
- Overall cardiac surgery-related mortality rate (cardiac surgery and other surgery), according to the CHD classification (adjusted for the severity of the CHD and the surgical procedure) and to geographic area
- Overall cardiac catheter-related mortality rate, according to the CHD classification (adjusted for the severity of the CHD and the catheterization procedure) and to geographic area
- CHD follow-up within and outside the national M3C network
- Periods of loss of cardiological follow-up (within or outside the M3C network, in hospital or in town)
- Obstetrical data for women (parity, pregnancy)
- The existence of a prenatal diagnosis (yes / no and the term of pregnancy at the time of diagnosis of CHD)
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, Paediatric cardiology, Epidemiology, M3C network
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with CHD hospitalized in France
Rate of patients with CHD hospitalized in France
Measured: 10 years
Secondary outcomes (5)
Rate of mortality in patients with CHD
Rate of mortality in patients with CHD
Measured: 10 years
Rate of cardiac surgery-related mortality in patients with CHD
Rate of cardiac surgery-related mortality in patients with CHD
Measured: 10 years
Rate of cardiac catheter-related mortality in patients with CHD
Rate of cardiac catheter-related mortality in patients with CHD
Measured: 10 years
Rate of CHD patient's loss to follow-up within and outside the national M3C network
Rate of CHD patient's loss to follow-up within and outside the national M3C network
Measured: 10 years
Rate of CHD prenatal diagnosis
Rate of CHD prenatal diagnosis
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Feb 2020
- Primary completion1 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 450,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- National Reference Center for Complex Congenital Heart Disease, Marie-Lannelongue Medical and Surgical Center, Le Plessis Robinson, University Hospital, Bordeaux
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD-PhD, Study director, UH MONTPELLIERSarah Cohen, Principal investigator, • Centre Médico-Chirurgical Marie-Lannelongue, Le Plessis RobinsonJean-Benoit Thambo, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740177
- Sponsor's protocol ID
- RECHMPL20_0119
- Acronym
- EPIDEMIO-CHD
- Status last verified
- Jan 2021
- First submitted
- 1 Feb 2021
- Last updated
- 16 Mar 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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Congenital Heart Disease in France : EPIDEMIO-CHD
- ClinicalTrials.gov ID
- NCT04740177
- Acronym / sponsor ID
- EPIDEMIO-CHD / RECHMPL20_0119
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, Paediatric cardiology, Epidemiology, M3C network
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- National Reference Center for Complex Congenital Heart Disease, Marie-Lannelongue Medical and Surgical Center, Le Plessis Robinson, University Hospital, Bordeaux
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 5 Feb 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%. Since the 1980s, France has been a pioneer in neonatal CHD surgery (Pr. Fontan, Pr. Lecomte, Pr. Serraf, etc.), in prenatal diagnosis, and in interventional cardiac catheterization.
Actually, first children operated for complex CHD have reached adulthood and a new epidemiology of CHD is emerging. Currently, one of the public health challenges is the need to maintain appropriate follow-up and to avoid disruption of care during the transition from adolescence to adulthood. Thus, the national health authorities (DGOS) recently certified a national network of expert centers for complex CHD (M3C).
In addition, under the leadership of the French Society of Cardiology, the sub-specialty of Pediatric and Congenital Cardiology has been recognized.
However, while North American and North European countries have published their updated data on the main indicators of CHD morbidity and mortality, no study has reported epidemiology of CHD in France.
Currently, available data are approximate, estimating that 200,000 children and 250,000 adults would be living in France with a CHD. Nevertheless, no information is available on hospitalizations, type of CHD, their follow-up, possible disruption in care, and morbidity and mortality in patients with CHD in France. This epidemiological study will use the national health insurance hospital database to answer these questions.
Detailed description
Retrospective epidemiological study based on the national health insurance hospital database from 2010 to 2020 (10 years):
Main objective:
- To assess the prevalence of patients with CHD hospitalized in France over 10 years.
Secondary objectives: asess over the same period:
- Overall mortality rate according to the CHD classification and the geographic area
- Overall morbidity rate, according to the CHD classification and the geographic area
- Overall cardiac surgery-related mortality rate (cardiac surgery and other surgery), according to the CHD classification (adjusted for the severity of the CHD and the surgical procedure) and to geographic area
- Overall cardiac catheter-related mortality rate, according to the CHD classification (adjusted for the severity of the CHD and the catheterization procedure) and to geographic area
- CHD follow-up within and outside the national M3C network
- Periods of loss of cardiological follow-up (within or outside the M3C network, in hospital or in town)
- Obstetrical data for women (parity, pregnancy)
- The existence of a prenatal diagnosis (yes / no and the term of pregnancy at the time of diagnosis of CHD)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with congenital heart disease (CHD)
Key inclusion criteria (1 listed)
- Patient (of any age) with a CHD as defined by the international ACC-CHD classification and listed in the ICD10 classification, hospitalized from 01/01/2010 to 12/31/2019 in a French tertiary care hospital from the M3C network.
Key exclusion criteria (1 listed)
- Patient with non-malformative genetic heart disease (cardiomyopathy, hereditary rhythmic disease).
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 patients with CHD hospitalized in France
Time frame: 10 years
Rate of patients with CHD hospitalized in France
5 secondary outcomes
Rate of mortality in patients with CHD
Time frame: 10 years
Rate of cardiac surgery-related mortality in patients with CHD
Time frame: 10 years
Rate of cardiac catheter-related mortality in patients with CHD
Time frame: 10 years
Rate of CHD patient's loss to follow-up within and outside the national M3C network
Time frame: 10 years
Rate of CHD prenatal diagnosis
Time frame: 10 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 16 Mar 2021.
- 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
Sarah Cohen principal investigator
• Centre Médico-Chirurgical Marie-Lannelongue, Le Plessis Robinson
Jean-Benoit Thambo principal investigator
University Hospital, Bordeaux
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 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 16 Mar 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 patients with CHD hospitalized in France (time frame: 10 years). 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 16 Mar 2021.