Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects
2 other identifiers
observational
76
1 country
1
Brief Summary
Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2019
CompletedAugust 13, 2019
August 1, 2019
4.2 years
February 27, 2015
August 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Hemodynamic status
Status as found by invasive and non-invasive assessment
Current at time of inclusion
Structural and functional hepatic changes
Status as found by non-invasive assessment
Current at time of inclusion
Cardio-pulmonary function and functional reserve
Status as found by non-invasive assessment
Current at time of inclusion
Quality of life and psycho-social outcome
Status as found by questionnaire
Current at time of inclusion
Study Arms (2)
Patient group
Adolescents (15-18 years of age) With univentricular heart defects and Fontan type palliation.
Control group
Age- and gender-matched healthy individuals
Eligibility Criteria
All adolescents i Norway with univentricular heart defects and Fontan type palliation
You may qualify if:
- age, heart defect, heart surgery and type of palliation/correction, informed consent
You may not qualify if:
- non-consenting, contraindications or increased risk to perform study tests (i.e. metal parts prohibiting MRI, motoric impairment prohibiting CPET)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- The Hospital for Sick Childrencollaborator
Study Sites (1)
Oslo University Hospital, Rikshospitalet, Department of Paediatric Cardiology
Oslo, 0424, Norway
Related Publications (1)
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.
PMID: 34921324DERIVED
Biospecimen
EDTA, citrate and serum samples for analysis for vitamin status, biochemical analysis, inflammation markers and organ specific markers.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Moller, MD PhD
Oslo University Hospital, University of Oslo
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior consultant pediatric cardiologist, MD PhD
Study Record Dates
First Submitted
February 27, 2015
First Posted
March 4, 2015
Study Start
March 1, 2015
Primary Completion
April 26, 2019
Study Completion
April 26, 2019
Last Updated
August 13, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share