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Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot (TOF-Cond)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00557934
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : September 19, 2008
Sponsor:
Collaborator:
Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany
Information provided by:
University Hospital Tuebingen

Tracking Information
First Submitted Date  ICMJE November 13, 2007
First Posted Date  ICMJE November 14, 2007
Last Update Posted Date September 19, 2008
Study Start Date  ICMJE October 2007
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2007)
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
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2008)
  • Brain natriuretic peptide [ Time Frame: at cath study ]
  • RV enddiastolic volume index (by MRI) [ Time Frame: within the last 6 months before study ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Right Ventricular Dysfunction
Intervention  ICMJE Other: dobutamine
dobutamine stress (10 µg/kg/min) for 10 minutes during heart catheterization
Study Arms  ICMJE Experimental: 1
Intervention: Other: dobutamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2008)
16
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2007)
30
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00557934
Other Study ID Numbers  ICMJE Cond-07-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Professor Dr. Michael Hofbeck, University Children's Hospital, Tuebingen, Germany
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University Hospital Tuebingen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany
Investigators  ICMJE
Principal Investigator: Michael Hofbeck, MD University Childrens Hospital, Department of Pediatric Cardiology
PRS Account University Hospital Tuebingen
Verification Date September 2008

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