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| Sponsors and Collaborators: |
University Hospital Tuebingen Foerdergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany |
| Information provided by: | University Hospital Tuebingen |
| ClinicalTrials.gov Identifier: | NCT00557934 |
Purpose
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. The valve replacement should not be performed too late so as to preserve function, yet not too early to avoid the requirement of frequent valve replacements, since the inserted prostheses have a limited lifespan.
Recently, MRI data for the determination of optimal timing of pulmonary valve replacement has been recommended. These recommendation are based on the measurement of right ventricular size and assessment of pulmonary regurgitation by MRI. To define right ventricular function more detailed informations about right ventricular contractility is required.
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.This approach has been validated and used to assess right ventricular function in patients with congenital heart disease and following corrective surgery.
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 difference between the slopes with/without dobutamine demonstrates the contractility reserve function of the right ventricle.
Purpose: To evaluate the correlation between right ventricular contractility reserve function and functional assessment by MRI to determine the optimal timing of pulmonary valve replacement after repair of tetralogy of Fallot.
| Condition | Intervention |
|
Right Ventricular Dysfunction |
Other: dobutamine |
| MedlinePlus related topics: | Stress |
| ChemIDplus related topics: | Dobutamine Dobutamine hydrochloride Dobutamine lactobionate Dobutamine tartrate |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Open Label, Single Group Assignment |
| Official Title: | Evaluation of Right Ventricular Contractility Reserve Function During Dobutamine Stress in Patients Following Surgical Repair of Tetralogy of Fallot - Correlation With Functional Assessment by MRI to Determine the Optimal Timing of Pulmonary Valve Replacement |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Other: dobutamine
dobutamine stress (10 µg/kg/min) for 10 minutes during heart catheterization
|
Eligibility
| Ages Eligible for Study: | 4 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christian Apitz, MD | -49-7071-2984751 | christian.apitz@med.uni-tuebingen.de |
| Contact: Michael Hofbeck, MD | -49-7071-2984751 | michael.hofbeck@med.uni-tuebingen.de |
| Germany, Baden-Wuerttemberg | |||||
| Department of Pediatric Cardiology, University Childrens Hospital | Recruiting | ||||
| Tuebingen, Baden-Wuerttemberg, Germany, 72076 | |||||
| Contact: Christian Apitz, MD -49-7071-2984751 christian.apitz@med.uni-tuebingen.de | |||||
| Contact: Michael Hofbeck, MD -49-7071-2984751 michael.hofbeck@med.uni-tuebingen.de | |||||
| University Hospital Tuebingen |
| Foerdergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany |
| Principal Investigator: | Michael Hofbeck, MD | University Childrens Hospital, Department of Pediatric Cardiology |
More Information
| Responsible Party: | University Childrens Hospital, Tuebingen, Germany ( Professor Dr Michael Hofbeck ) |
| Study ID Numbers: | Cond-07-1 |
| First Received: | November 13, 2007 |
| Last Updated: | June 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00557934 |
| Health Authority: | Germany: Ethics Commission |
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