Congenital Heart DiseaseNCT02026557
Mortality Among Children With Congenital Heart Defects in Norway
An observational study of Congenital Heart Disease, run by Sorlandet Hospital HF.
Trial summary
To describe mortality among children with congenital heart defects in Norway Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 1994to Jul 2017
- 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: Oslo University hospital´s registry of patients with congenital heart diseases
Who may be able to join
- children with congenital heart defects
Who cannot join
- no
About this study
To describe mortality among children with congenital heart defects in Norway
- Conditions
- Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of death until 31 dec 2012 among Norwegian children with congenital heart defects born 1994-2009
Measured: 31.12.2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startJan 1994
- Primary completionDec 2009
- Study completionJul 2017
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 Congenital Heart DiseaseStudies 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
- Retrospective
- Enrolment
- 15,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- University of Oslo, University of Bergen, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Jarle Jortveit, PhD, Principal investigator, Sorlandet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026557
- Sponsor's protocol ID
- 2010/392
- Status last verified
- Jul 2017
- First submitted
- 2 Jul 2013
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jortveit J, Leirgul E, Eskedal L, Greve G, Fomina T, Dohlen G, Tell GS, Birkeland S, Oyen N, Holmstrom H. Mortality and complications in 3495 children with isolated ventricular septal defects. Arch Dis Child. 2016 Sep;101(9):808-13. doi: 10.1136/archdischild-2015-310154. Epub 2016 Apr 18.
PubMed 27091847
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality Among Children With Congenital Heart Defects in Norway
- ClinicalTrials.gov ID
- NCT02026557
- Acronym / sponsor ID
- 2010/392
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- University of Oslo, University of Bergen, Oslo University Hospital
- Study start
- Jan 1994 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 3 Jan 2014 (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.
To describe mortality among children with congenital heart defects in Norway
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
- Oslo University hospital´s registry of patients with congenital heart diseases
Key inclusion criteria (1 listed)
- children with congenital heart defects
Key exclusion criteria (1 listed)
- no
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
Number of death until 31 dec 2012 among Norwegian children with congenital heart defects born 1994-2009
Time frame: 31.12.2010
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 26 Jul 2017.
- Derived from this study: PubMed 27091847Jortveit J, Leirgul E, Eskedal L, Greve G, Fomina T, Dohlen G, Tell GS, Birkeland S, Oyen N, Holmstrom H. Mortality and complications in 3495 children with isolated ventricular septal defects. Arch Dis Child. 2016 Sep;101(9):808-13. doi: 10.1136/archdischild-2015-310154. Epub 2016 Apr 18.
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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.
Jarle Jortveit, PhD principal investigator
Sorlandet Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Sorlandet Hospital HF.
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 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of death until 31 dec 2012 among Norwegian children with congenital heart defects born 1994-2009 (time frame: 31.12.2010). 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 NCT02026557, 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 26 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.