Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot (TOF-Cond)
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|ClinicalTrials.gov Identifier: NCT00557934|
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : September 19, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Right Ventricular Dysfunction||Other: dobutamine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Right Ventricular Contractility Reserve Function During Dobutamine Stress in Patients Following Surgical Repair of Tetralogy of Fallot|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
dobutamine stress (10 µg/kg/min) for 10 minutes during heart catheterization
- 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 ]
- Brain natriuretic peptide [ Time Frame: at cath study ]
- RV enddiastolic volume index (by MRI) [ Time Frame: within the last 6 months before study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557934
|Department of Pediatric Cardiology, University Childrens Hospital|
|Tuebingen, Baden-Wuerttemberg, Germany, 72076|
|Principal Investigator:||Michael Hofbeck, MD||University Childrens Hospital, Department of Pediatric Cardiology|