Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot

NCT ID: NCT00557934

Last Updated: 2008-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-09-30

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.

Conditions

Right Ventricular Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

dobutamine

Intervention Type: OTHER

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

Interventions

dobutamine

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany

UNKNOWN

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

University Children's Hospital, Tuebingen, Germany

Principal Investigators

Michael Hofbeck, MD

Role: PRINCIPAL_INVESTIGATOR

University Childrens Hospital, Department of Pediatric Cardiology

Locations

Department of Pediatric Cardiology, University Childrens Hospital

Tübingen, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

Cond-07-1

Identifier Type: -

Identifier Source: org_study_id