Congenital Heart DiseaseNCT02378857
Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects
An observational study of Congenital Heart Disease, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 76 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2015to 26 Apr 2019
- 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 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All adolescents i Norway with univentricular heart defects and Fontan type palliation
Who may be able to join
- age, heart defect, heart surgery and type of palliation/correction, informed consent
Who cannot join
- non-consenting, contraindications or increased risk to perform study tests (i.e. metal parts prohibiting MRI, motoric impairment prohibiting CPET)
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, Rikshospitalet, Department of Paediatric Cardiology
Oslo, 0424
About this study
Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation.
Read the detailed description
A study group of 40-50 individuals will be investigated by non-invasive and invasive methods, including echocardiography at rest and during exercise, heart catheterization with advanced hemodynamic studies, cardiac and abdominal MRI, abdominal ultrasound and transient elastography, quality of life assessment and cardiopulmonary exercise testing. A selection of tests will be performed in a healthy control group as well.
- Conditions
- Congenital Heart Disease
- Keywords
- Univentricular heart defect, Fontan circulation
- 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 |
|---|---|---|
| Patient group | Adolescents (15-18 years of age) With univentricular heart defects and Fontan type palliation. | |
| Control group | Age- and gender-matched healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic status
Status as found by invasive and non-invasive assessment
Measured: Current at time of inclusion
Structural and functional hepatic changes
Status as found by non-invasive assessment
Measured: Current at time of inclusion
Cardio-pulmonary function and functional reserve
Status as found by non-invasive assessment
Measured: Current at time of inclusion
Quality of life and psycho-social outcome
Status as found by questionnaire
Measured: Current at time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
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.
- More trials run by Oslo University HospitalThe 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
- Cross-sectional
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Principal investigator, Thomas Möller, Oslo University Hospital
- Investigators
- Thomas Moller, MD PhD, Principal investigator, Oslo University Hospital, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378857
- Sponsor's protocol ID
- 2013/1331 (REK)
- Other IDs
- 2014077
- Status last verified
- Aug 2019
- First submitted
- 27 Feb 2015
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Moller T, Klungerbo V, Diab S, Holmstrom H, Edvardsen E, Grindheim G, Brun H, Thaulow E, Kohn-Luque A, Rosner A, Dohlen G. Circulatory Response to Rapid Volume Expansion and Cardiorespiratory Fitness in Fontan Circulation. Pediatr Cardiol. 2022 Apr;43(4):903-913. doi: 10.1007/s00246-021-02802-y. Epub 2021 Dec 17.
PubMed 34921324
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects
- ClinicalTrials.gov ID
- NCT02378857
- Acronym / sponsor ID
- 2013/1331 (REK)
- Conditions
- Congenital Heart Disease
- Keywords
- Univentricular heart defect, Fontan circulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- Mar 2015
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 4 Mar 2015 (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.
Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation.
Detailed description
A study group of 40-50 individuals will be investigated by non-invasive and invasive methods, including echocardiography at rest and during exercise, heart catheterization with advanced hemodynamic studies, cardiac and abdominal MRI, abdominal ultrasound and transient elastography, quality of life assessment and cardiopulmonary exercise testing. A selection of tests will be performed in a healthy control group as well.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | –Adolescents (15-18 years of age) With univentricular heart defects and Fontan type palliation. |
| Control group | – | –Age- and gender-matched healthy individuals |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All adolescents i Norway with univentricular heart defects and Fontan type palliation
Key inclusion criteria (1 listed)
- age, heart defect, heart surgery and type of palliation/correction, informed consent
Key exclusion criteria (1 listed)
- non-consenting, contraindications or increased risk to perform study tests (i.e. metal parts prohibiting MRI, motoric impairment prohibiting CPET)
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
Hemodynamic status
Time frame: Current at time of inclusion
Status as found by invasive and non-invasive assessment
Structural and functional hepatic changes
Time frame: Current at time of inclusion
Status as found by non-invasive assessment
Cardio-pulmonary function and functional reserve
Time frame: Current at time of inclusion
Status as found by non-invasive assessment
Quality of life and psycho-social outcome
Time frame: Current at time of inclusion
Status as found by questionnaire
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 13 Aug 2019.
- Derived from this study: PubMed 34921324Moller T, Klungerbo V, Diab S, Holmstrom H, Edvardsen E, Grindheim G, Brun H, Thaulow E, Kohn-Luque A, Rosner A, Dohlen G. Circulatory Response to Rapid Volume Expansion and Cardiorespiratory Fitness in Fontan Circulation. Pediatr Cardiol. 2022 Apr;43(4):903-913. doi: 10.1007/s00246-021-02802-y. Epub 2021 Dec 17.
- Individual participant dataSharing planned: No
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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.
Thomas Moller, MD PhD principal investigator
Oslo University Hospital, University of Oslo
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 Oslo University Hospital at 1 site in Norway.
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 13 Aug 2019. 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 Norway. 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?
Hemodynamic status (time frame: Current at time of inclusion). The study lists 4 primary outcomes in all. 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 NCT02378857, 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 13 Aug 2019.