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NCT02378857 Clinical Trial

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

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02378857
Other study ID # 2013/1331 (REK)
Secondary ID 2014077
Status Completed
Phase
First received
Last updated
Start date March 2015
Est. completion date April 26, 2019

Study information
Verified date August 2019
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation.

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.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date April 26, 2019
Est. primary completion date April 26, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 18 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Oslo University Hospital, Rikshospitalet, Department of Paediatric Cardiology Oslo

Sponsors (2)
Lead Sponsor Collaborator
Oslo University Hospital The Hospital for Sick Children

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemodynamic status Status as found by invasive and non-invasive assessment Current at time of inclusion
Primary Structural and functional hepatic changes Status as found by non-invasive assessment Current at time of inclusion
Primary Cardio-pulmonary function and functional reserve Status as found by non-invasive assessment Current at time of inclusion
Primary Quality of life and psycho-social outcome Status as found by questionnaire Current at time of inclusion
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