Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot

Right Ventricular Dysfunction Clinical Trial

— TOF-Cond  

Official title:

Evaluation of Right Ventricular Contractility Reserve Function During Dobutamine Stress in Patients Following Surgical Repair of Tetralogy of Fallot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557934
• Other study ID #: Cond-07-1
• Status: Completed
• Phase: N/A
• First received: November 13, 2007
• Last updated: September 17, 2008
• Start date: October 2007
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Right Ventricular Dysfunction
• Tetralogy of Fallot
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Pediatric Cardiology, University Childrens Hospital	Tuebingen	Baden-Wuerttemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Brain natriuretic peptide		at cath study	No
Secondary	RV enddiastolic volume index (by MRI)		within the last 6 months before study	No