Study Results
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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RECRUITING
NA
200 participants
INTERVENTIONAL
2020-09-01
2041-09-01
Brief Summary
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The registry study described in this protocol is intended to identify factors that influence the treatment outcome of patients in the Fontan circulation in the long term through systematic prospective documentation of the data from our standardized and guideline-oriented treatment.
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Detailed Description
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1. The development of lymphatic drainage disorders (7-9)
2. The cellular changes of the immunological system and metabolome (10) In addition to the clinical routine, weight-adapted EDTA blood for the isolation of peripheral blood mononuclear cells (PBMCs) for the scientific investigation of immunological changes and serum for the analysis of the metabolome will be examined at three times (Figure 1: Times 2, 4, 7) as part of a routine blood sample (10).
3. The recording and treatment of psychological, social and developmental abnormalities with the help of standardized questionnaires.
4. The evaluation of special sonography examinations of the liver and kidney in the long-term course, as well as their treatment.
5. The assessment of the hemodynamic peculiarities and the classification with regard to Cardiac function in the long-term course of patients with Fontan circulation.
6. The assessment of various laboratory parameters as risk parameters for the development of complications.
7. The recording of cardiopulmonary performance in the long-term course and its ability to be influenced by education regarding sporting activity and the handing over of an individualized training plan.
8. The influence of physical activity on possible complications of Fontan circulation.
9. The influence of early psychological, nutritional, or social intervention in the event of abnormalities on later complications of Fontan circulation.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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TCPC completed
All patients after TCPC completion
Univentricular Hearts
Prevention when factors are recognized
Interventions
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Univentricular Hearts
Prevention when factors are recognized
Eligibility Criteria
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Inclusion Criteria
6 Years
60 Years
ALL
No
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Principal Investigators
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Sven Dittrich, Prof.
Role: STUDY_CHAIR
Universitätsklinikum Erlangen
Locations
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Universitätsklinikum
Erlangen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21-195_1-B
Identifier Type: -
Identifier Source: org_study_id
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