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Completed

NCT Number: NCT00557934

Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot

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.

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Key information

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Cardiology, University Childrens Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dobutamine

Other

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

Primary outcomes

  1. 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 outcomes

  1. Brain natriuretic peptide

    Time frame: at cath study

  2. RV enddiastolic volume index (by MRI)

    Time frame: within the last 6 months before study

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany

Registry information

Official study title

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

Acronym: TOF-Cond

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 14, 2007
Registry last updated
Sep 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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