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

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Right Ventricular Dysfunction Other: dobutamine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Right Ventricular Contractility Reserve Function During Dobutamine Stress in Patients Following Surgical Repair of Tetralogy of Fallot
Study Start Date : October 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Other: dobutamine
dobutamine stress (10 µg/kg/min) for 10 minutes during heart catheterization


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Brain natriuretic peptide [ Time Frame: at cath study ]
  2. RV enddiastolic volume index (by MRI) [ Time Frame: within the last 6 months before study ]

Eligibility Criteria
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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557934


Locations
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Germany
Department of Pediatric Cardiology, University Childrens Hospital
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany
Investigators
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Principal Investigator: Michael Hofbeck, MD University Childrens Hospital, Department of Pediatric Cardiology
More Information
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Responsible Party: Professor Dr. Michael Hofbeck, University Children's Hospital, Tuebingen, Germany
ClinicalTrials.gov Identifier: NCT00557934    
Other Study ID Numbers: Cond-07-1
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008
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
Additional relevant MeSH terms:
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Ventricular Dysfunction
Tetralogy of Fallot
Ventricular Dysfunction, Right
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Dobutamine
Cardiotonic Agents
Sympathomimetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents