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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 13, 2007 | ||||
| Last Updated Date | September 17, 2008 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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 start of dobutamine infusion ] | ||||
| Change History | Complete list of historical versions of study NCT00557934 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Correlation of elastance with functional reserve (FR) based on the equation FR = EFstress - EFrest [ Time Frame: 10 minutes after starting dobutamine ] [ Designated as safety issue: No ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot | ||||
| Official Title ICMJE | Evaluation of Right Ventricular Contractility Reserve Function During Dobutamine Stress in Patients Following Surgical Repair of Tetralogy of Fallot | ||||
| Brief Summary | Background: Residual pulmonary regurgitation following repair of tetralogy of Fallot, in particular the use of a transannular patch, has been shown to correlate with the development of right ventricular dysfunction. Optimal timing of pulmonary valve replacement, therefore, is important to preserve right ventricular function. Several recent studies suggested that a threshold of right ventricular end-diastolic volume for intervention, in order to preserve the likelihood of adequate reverse remodeling, is in the region of 150 to 200 ml/m2 body surface area. However, there is evidence that right ventricular function does not always recover following pulmonary valve replacement even if the end-diastolic volume is below this cut-off. In addition, previous studies suggested that early dysfunction may be present before symptoms occur. However, early dysfunction is difficult to assess. Methods: Analysis of right ventricular function by pressure-volume loops has been extensively evaluated in experimental studies and is generally considered the optimal way to quantify right ventricular function. By recording a family of pressure-volume loops during reduction of preload, achieved by temporary balloon occlusion of the inferior caval vein, the contractility can be calculated by the slope of the endsystolic pressure-volume relation (elastance). Changes of contractility following dobutamine infusion could be noted by changes of elastance. The increase of the slope during dobutamine demonstrates the contractility reserve of the right ventricle. Purpose: To evaluate the right ventricular contractility reserve to determine early ventricular dysfunction after repair of tetralogy of Fallot. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic, Open Label, Single Group Assignment | ||||
| Condition ICMJE | Right Ventricular Dysfunction | ||||
| Intervention ICMJE | Other: dobutamine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 16 | ||||
| Completion Date | September 2008 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 4 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00557934 | ||||
| Responsible Party | Professor Dr. Michael Hofbeck, University Children's Hospital, Tuebingen, Germany | ||||
| Study ID Numbers ICMJE | Cond-07-1 | ||||
| Study Sponsor ICMJE | University Hospital Tuebingen | ||||
| Collaborators ICMJE | Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital Tuebingen | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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