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Completed

NCT Number: NCT02378857

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

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

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

15 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital, Rikshospitalet, Department of Paediatric Cardiology

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Hemodynamic status

    Time frame: Current at time of inclusion

    Status as found by invasive and non-invasive assessment

  2. Structural and functional hepatic changes

    Time frame: Current at time of inclusion

    Status as found by non-invasive assessment

  3. Cardio-pulmonary function and functional reserve

    Time frame: Current at time of inclusion

    Status as found by non-invasive assessment

  4. Quality of life and psycho-social outcome

    Time frame: Current at time of inclusion

    Status as found by questionnaire

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • The Hospital for Sick Children

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2015
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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