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Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects

Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02378857
Enrollment
76
Registered
2015-03-04
Start date
2015-03-31
Completion date
2019-04-26
Last updated
2019-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

Univentricular heart defect, Fontan circulation

Brief summary

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.

Interventions

None listed

Sponsors

The Hospital for Sick Children
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
15 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* age, heart defect, heart surgery and type of palliation/correction, informed consent

Exclusion criteria

* non-consenting, contraindications or increased risk to perform study tests (i.e. metal parts prohibiting MRI, motoric impairment prohibiting CPET)

Design outcomes

Primary

MeasureTime frameDescription
Hemodynamic statusCurrent at time of inclusionStatus as found by invasive and non-invasive assessment
Structural and functional hepatic changesCurrent at time of inclusionStatus as found by non-invasive assessment
Cardio-pulmonary function and functional reserveCurrent at time of inclusionStatus as found by non-invasive assessment
Quality of life and psycho-social outcomeCurrent at time of inclusionStatus as found by questionnaire

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026