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| Sponsors and Collaborators: |
University Hospital Tuebingen Fördergemeinschaft 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. 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 | Intervention |
|---|---|
|
Right Ventricular Dysfunction |
Other: dobutamine |
| 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 |
| Enrollment: | 16 |
| Study Start Date: | October 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (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| Germany, Baden-Wuerttemberg | |
| Department of Pediatric Cardiology, University Childrens Hospital | |
| Tuebingen, Baden-Wuerttemberg, Germany, 72076 | |
| Principal Investigator: | Michael Hofbeck, MD | University Childrens Hospital, Department of Pediatric Cardiology |
More Information
| Responsible Party: | University Children's Hospital, Tuebingen, Germany ( Professor Dr. Michael Hofbeck ) |
| Study ID Numbers: | Cond-07-1 |
| Study First Received: | November 13, 2007 |
| Last Updated: | September 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00557934 History of Changes |
| Health Authority: | Germany: Ethics Commission |
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tetralogy of Fallot right ventricular dysfunction pulmonary insufficiency |
pulmonary valve replacement pressure-volume loops long-term follow-up in tetralogy of Fallot |
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Ventricular Dysfunction Neurotransmitter Agents Heart Diseases Adrenergic beta-Agonists Cardiovascular Abnormalities Adrenergic Agents Ventricular Dysfunction, Right Stress |
Cardiovascular Agents Adrenergic Agonists Dobutamine Fallot Tetralogy Tetralogy of Fallot Peripheral Nervous System Agents Congenital Abnormalities Heart Defects, Congenital |
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Ventricular Dysfunction Neurotransmitter Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists Cardiovascular Abnormalities Sympathomimetics Cardiotonic Agents Physiological Effects of Drugs Ventricular Dysfunction, Right Cardiovascular Agents |
Protective Agents Adrenergic Agonists Dobutamine Pharmacologic Actions Autonomic Agents Therapeutic Uses Tetralogy of Fallot Cardiovascular Diseases Peripheral Nervous System Agents Congenital Abnormalities Heart Defects, Congenital |