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Right Ventricular Contractility Reserve Function in Patients Following Surgical Repair of Tetralogy of Fallot (TOF-Cond)

This study is currently recruiting participants.
Verified by University Hospital Tuebingen, June 2008

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   

U.S. FDA Resources

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

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557934

Contacts
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    

Locations
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    

Sponsors and Collaborators
University Hospital Tuebingen
Foerdergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany

Investigators
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

Keywords provided by University Hospital Tuebingen:
tetralogy of Fallot  
right ventricular dysfunction  
pulmonary insufficiency  
pulmonary valve replacement
pressure-volume loops
long-term follow-up in tetralogy of Fallot

Study placed in the following topic categories:
Ventricular Dysfunction
Heart Diseases
Cardiovascular Abnormalities
Ventricular Dysfunction, Right
Tetralogy of Fallot
Fallot tetralogy
Stress
Congenital Abnormalities
Heart Defects, Congenital
Dobutamine

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Adrenergic Agents
Cardiotonic Agents
Sympathomimetics
Physiological Effects of Drugs
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Adrenergic Agonists
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008




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