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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: |
NCT00557934 |
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Date of registration:
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13/11/2007 |
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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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Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot
TOF-Cond |
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Scientific title:
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Evaluation of Right Ventricular Contractility Reserve Function During Dobutamine Stress in Patients Following Surgical Repair of Tetralogy of Fallot |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00557934 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Michael Hofbeck, MD |
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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 Childrens Hospital, Department of Pediatric Cardiology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Corrected tetralogy of Fallot or other surgery with involvement of the pulmonary
valve, chronic pulmonary regurgitation, dilated right ventricle
2. Patient's age > 4 years
3. Routine cardiac catheterization clinically indicated for deciding therapeutic
treatment
4. Informed assent/consent of patients/parent.
Exclusion Criteria:
1. Pregnancy/breast feeding, women of child-bearing age without contraception.
2. Present participation, and/or participation in a clinical study during the last 4
weeks.
3. Illnesses or malfunctions, which exclude a participation in this study after decision
of the investigating physician.
4. Other medical, psychological or social circumstances which complicate a regular
participation in the study, and/or increase the risk for the patients themselves.
Age minimum:
4 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Right Ventricular Dysfunction
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Intervention(s)
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Other: dobutamine
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Primary Outcome(s)
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Percentage of change of the maximal elastance (slope of the endsystolic pressure-volume relation)of the right ventricle following dobutamine infusion
[Time Frame: 10 minutes after starting dobutamine infusion]
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Secondary Outcome(s)
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Brain natriuretic peptide
[Time Frame: at cath study]
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RV enddiastolic volume index (by MRI)
[Time Frame: within the last 6 months before study]
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Secondary ID(s)
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Cond-07-1
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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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