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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00263406 |
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Date of registration:
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04/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
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Scientific title:
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Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation |
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Date of first enrolment:
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December 2002 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00263406 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Guy Van Nooten, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Ghent |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All consecutive children with a univentricular heart disease undergoing elective
surgery for creation of a Fontan circulation
- Parents have agreed with the study after informed consent
Exclusion Criteria:
- Urgent / Emergent surgery
- Preoperative use of an ACE-inhibitor
Age minimum:
1 Month
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation
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Intervention(s)
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Drug: Administration of an ACE-inhibitor or not
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Primary Outcome(s)
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Duration of the pleural drainage in the first two postoperative weeks
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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