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

NCT ID: NCT02378857

Last Updated: 2019-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-04-26

Brief Summary

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

Detailed Description

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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

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Congenital Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patient group

Adolescents (15-18 years of age) With univentricular heart defects and Fontan type palliation.

No interventions assigned to this group

Control group

Age- and gender-matched healthy individuals

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

15 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thomas Möller

Senior consultant pediatric cardiologist, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Moller, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, University of Oslo

Locations

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Oslo University Hospital, Rikshospitalet, Department of Paediatric Cardiology

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 34921324 (View on PubMed)

Other Identifiers

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2014077

Identifier Type: OTHER

Identifier Source: secondary_id

2013/1331 (REK)

Identifier Type: -

Identifier Source: org_study_id

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