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

Primary Purpose

Right Ventricular Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
dobutamine
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Right Ventricular Dysfunction focused on measuring tetralogy of Fallot, right ventricular dysfunction, pulmonary insufficiency, pulmonary valve replacement, pressure-volume loops, long-term follow-up in tetralogy of Fallot

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Pediatric Cardiology, University Childrens Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Percentage of change of the maximal elastance (slope of the endsystolic pressure-volume relation)of the right ventricle following dobutamine infusion

Secondary Outcome Measures

Brain natriuretic peptide
RV enddiastolic volume index (by MRI)

Full Information

First Posted
November 13, 2007
Last Updated
September 17, 2008
Sponsor
University Hospital Tuebingen
Collaborators
Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00557934
Brief Title
Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot
Acronym
TOF-Cond
Official Title
Evaluation of Right Ventricular Contractility Reserve Function During Dobutamine Stress in Patients Following Surgical Repair of Tetralogy of Fallot
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Tuebingen
Collaborators
Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Ventricular Dysfunction
Keywords
tetralogy of Fallot, right ventricular dysfunction, pulmonary insufficiency, pulmonary valve replacement, pressure-volume loops, long-term follow-up in tetralogy of Fallot

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
dobutamine
Intervention Description
dobutamine stress (10 µg/kg/min) for 10 minutes during heart catheterization
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Brain natriuretic peptide
Time Frame
at cath study
Title
RV enddiastolic volume index (by MRI)
Time Frame
within the last 6 months before study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Corrected tetralogy of Fallot or other surgery with involvement of the pulmonary valve, chronic pulmonary regurgitation, dilated right ventricle Patient's age > 4 years Routine cardiac catheterization clinically indicated for deciding therapeutic treatment Informed assent/consent of patients/parent. Exclusion Criteria: Pregnancy/breast feeding, women of child-bearing age without contraception. Present participation, and/or participation in a clinical study during the last 4 weeks. Illnesses or malfunctions, which exclude a participation in this study after decision of the investigating physician. Other medical, psychological or social circumstances which complicate a regular participation in the study, and/or increase the risk for the patients themselves.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hofbeck, MD
Organizational Affiliation
University Childrens Hospital, Department of Pediatric Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric Cardiology, University Childrens Hospital
City
Tuebingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

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Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot

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