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Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot (TOF-Cond)
This study has been completed.
Study NCT00557934   Information provided by University Hospital Tuebingen
First Received: November 13, 2007   Last Updated: September 17, 2008   History of Changes

November 13, 2007
September 17, 2008
October 2007
September 2008   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00557934 on ClinicalTrials.gov Archive Site
  • Brain natriuretic peptide [ Time Frame: at cath study ] [ Designated as safety issue: No ]
  • RV enddiastolic volume index (by MRI) [ Time Frame: within the last 6 months before study ] [ Designated as safety issue: No ]
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 ]
 
Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot
Evaluation of Right Ventricular Contractility Reserve Function During Dobutamine Stress in Patients Following Surgical Repair of Tetralogy of Fallot

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.

 
 
Interventional
Diagnostic, Open Label, Single Group Assignment
Right Ventricular Dysfunction
Other: dobutamine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
16
September 2008
September 2008   (final data collection date for primary outcome measure)

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.
Both
4 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00557934
Professor Dr. Michael Hofbeck, University Children's Hospital, Tuebingen, Germany
Cond-07-1
University Hospital Tuebingen
Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany
Principal Investigator: Michael Hofbeck, MD University Childrens Hospital, Department of Pediatric Cardiology
University Hospital Tuebingen
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP