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

This study has been completed.
Sponsor:
Collaborator:
Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00557934
First received: November 13, 2007
Last updated: September 17, 2008
Last verified: September 2008
  Purpose

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 Intervention
Right Ventricular Dysfunction
Other: dobutamine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brain natriuretic peptide [ Time Frame: at cath study ] [ Designated as safety issue: No ]
  • RV enddiastolic volume index (by MRI) [ Time Frame: within the last 6 months before study ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: October 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: dobutamine
dobutamine stress (10 µg/kg/min) for 10 minutes during heart catheterization

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00557934

Locations
Germany
Department of Pediatric Cardiology, University Childrens Hospital
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany
Investigators
Principal Investigator: Michael Hofbeck, MD University Childrens Hospital, Department of Pediatric Cardiology
  More Information

No publications provided

Responsible Party: Professor Dr. Michael Hofbeck, University Children's Hospital, Tuebingen, Germany
ClinicalTrials.gov Identifier: NCT00557934     History of Changes
Other Study ID Numbers: Cond-07-1
Study First Received: November 13, 2007
Last Updated: September 17, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:
tetralogy of Fallot
right ventricular dysfunction
pulmonary insufficiency
pulmonary valve replacement
pressure-volume loops
long-term follow-up in tetralogy of Fallot

Additional relevant MeSH terms:
Tetralogy of Fallot
Ventricular Dysfunction, Right
Ventricular Dysfunction
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Dobutamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 15, 2014