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

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Completed

CT.gov ID

NCT00557934

Collaborator

Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany (Other)

Enrollment

Location

Arm

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Right Ventricular Dysfunction	Other: dobutamine	N/A

Study Design

Study Type:

Interventional

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 :

Oct 1, 2007

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Other: dobutamine

dobutamine stress (10 µg/kg/min) for 10 minutes during heart catheterization

Outcome Measures

Primary Outcome Measures

Percentage of change of the maximal elastance (slope of the endsystolic pressure-volume relation)of the right ventricle following dobutamine infusion [10 minutes after starting dobutamine infusion]

Secondary Outcome Measures

Brain natriuretic peptide [at cath study]
RV enddiastolic volume index (by MRI) [within the last 6 months before study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.