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

• ClinicalTrials.gov Identifier: NCT00557934
• Recruitment Status: Completed
• First Posted: November 14, 2007
• Last Update Posted: September 19, 2008
• Sponsor: University Hospital Tuebingen
• Collaborator: Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany
• Information provided by: University Hospital Tuebingen

Tracking Information

• First Submitted Date: November 13, 2007
• First Posted Date: November 14, 2007
• Last Update Posted Date: September 19, 2008
• Study Start Date: October 2007
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 3, 2008): 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 ]
• Original Primary Outcome Measures (submitted: November 13, 2007): 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 start of dobutamine infusion ]

Current Secondary Outcome Measures (submitted: September 17, 2008)

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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot
• Official Title: Evaluation of Right Ventricular Contractility Reserve Function During Dobutamine Stress in Patients Following Surgical Repair of Tetralogy of Fallot

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Right Ventricular Dysfunction

Intervention

Other: dobutamine

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

Study Arms

Experimental: 1

Intervention: Other: dobutamine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 17, 2008): 16
• Original Estimated Enrollment (submitted: November 13, 2007): 30
• Actual Study Completion Date: September 2008
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00557934
• Other Study ID Numbers: Cond-07-1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Professor Dr. Michael Hofbeck, University Children's Hospital, Tuebingen, Germany
• Original Responsible Party: Not Provided
• Current Study Sponsor: University Hospital Tuebingen
• Original Study Sponsor: Same as current
• Collaborators: Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany

Investigators

• Principal Investigator: Michael Hofbeck, MD; University Childrens Hospital, Department of Pediatric Cardiology

• PRS Account: University Hospital Tuebingen
• Verification Date: September 2008