Congenital Heart DiseaseCARLNCT02897323
Northwest Adult Congenital Heart Disease Observatory
An observational study of Congenital Heart Disease, run by University Hospital, Caen at 1 site in France.
Trial summary
The incidence of congenital heart disease is about 8 per thousand live births. Thanks to advances in cardiac surgery, 90% of children born with heart defects reach adolescence and adulthood. Congenital heart defects are the leading cause of heart disease in young adults and expectant mothers in Western countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- description
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2016to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients visiting the participating centers meet the following criteria: * Patient, male or female, aged 18 years * with congenital heart disease operated or non-operated * Followed by a cardiologist specializing in congenital heart disease in the inter northwest region of France
Who may be able to join
- Patient, male or female, aged 18 years
- Congenital heart disease operated or non-operated
- Followed by a cardiologist specializing in congenital heart disease in the inter northwest region of France
Who cannot join
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Fabien Labombarda contact
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen
Fabien LABOMBARDA
About this study
Official title: Northwest Inter Hospital Adult Congenital Heart Disease Observatory
The incidence of congenital heart disease is about 8 per thousand live births. Thanks to advances in cardiac surgery, 90% of children born with heart defects reach adolescence and adulthood. Congenital heart defects are the leading cause of heart disease in young adults and expectant mothers in Western countries. The number of patients increases continuously as life expectancy increases. An increasing number of patients with complex heart defects survive to adulthood. The medico-surgical management of this highly specialized growing number of patients is difficult and requires a multidisciplinary collaboration. In France, an estimated 200,000 patients the number of carrier patients with congenital heart disease. Half of them will require monitoring, medical procedures, catheterizations and/or surgical re-intervention. No objective demographic data are currently available on the French patients. So, the investigators decided to set up an epidemiological project to better understand this cohort of patients. The main objective of this project is to obtain accurate epidemiological data needed to adapt the supply of care.
- Conditions
- Congenital Heart Disease
- Being tested
- description
- 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.
descriptionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
patients characteristics description
Obtain epidemiological data on adult congenital of the population followed in northwest region of France
Measured: baseline
Secondary outcomes (2)
heart disease complications description
Measured: baseline
complications during pregnancy description
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start14 Nov 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2020 (estimated)
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, CaenThe 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
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897323
- Sponsor's protocol ID
- 14-140
- Acronym
- CARL
- Status last verified
- Nov 2017
- First submitted
- 29 Aug 2016
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Northwest Inter Hospital Adult Congenital Heart Disease Observatory
- ClinicalTrials.gov ID
- NCT02897323
- Acronym / sponsor ID
- CARL / 14-140
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- 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 incidence of congenital heart disease is about 8 per thousand live births. Thanks to advances in cardiac surgery, 90% of children born with heart defects reach adolescence and adulthood. Congenital heart defects are the leading cause of heart disease in young adults and expectant mothers in Western countries. The number of patients increases continuously as life expectancy increases. An increasing number of patients with complex heart defects survive to adulthood. The medico-surgical management of this highly specialized growing number of patients is difficult and requires a multidisciplinary collaboration. In France, an estimated 200,000 patients the number of carrier patients with congenital heart disease. Half of them will require monitoring, medical procedures, catheterizations and/or surgical re-intervention. No objective demographic data are currently available on the French patients. So, the investigators decided to set up an epidemiological project to better understand this cohort of patients. The main objective of this project is to obtain accurate epidemiological data needed to adapt the supply of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients visiting the participating centers meet the following criteria: * Patient, male or female, aged 18 years * with congenital heart disease operated or non-operated * Followed by a cardiologist specializing in congenital heart disease in the inter northwest region of France
Key inclusion criteria (3 listed)
- Patient, male or female, aged 18 years
- Congenital heart disease operated or non-operated
- Followed by a cardiologist specializing in congenital heart disease in the inter northwest region of France
Key exclusion criteria (1 listed)
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| description | Other | – |
Primary outcome
patients characteristics description
Time frame: baseline
Obtain epidemiological data on adult congenital of the population followed in northwest region of France
2 secondary outcomes
heart disease complications description
Time frame: baseline
complications during pregnancy description
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Fabien Labombarda contact
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, Caen 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 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: status not confirmed, as of the sponsor's last update on 30 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabien Labombarda (0231064767 ext. +33), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients characteristics description (time frame: baseline). 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 30 Nov 2017.