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Cardiac Function Under Stress for Early Detection of the Right Ventricular Insufficiency After Repair of Tetralogy of Fallot

NCT00564993 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2012-06-06

No results posted yet for this study

Summary

Summary:

The investigators aim to identify markers of right ventricular dysfunction in patients with severe pulmonary regurgitation following repair of Tetralogy of Fallot, that allow prediction of the optimal timing of the replacement of the regurgitant valve. The investigators will use MR as a gold-standard reference for measurement of cardiac function during rest and dobutamine stress. The investigators will also evaluate the predictive potential of tissue Doppler imaging in this patient group.

Purpose:

To predict the optimum timing of pulmonary valve replacement for severe regurgitation in repaired Tetralogy of Fallot using Cardiac Magnetic resonance with dobutamine stress testing.

Conditions

  • Tetralogy of Fallot

Interventions

DRUG

Dobutamin

10\&20 µg/kg/min

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Competence Network for Congenital Heart Defects

    lead OTHER_GOV

Principal Investigators

  • Philipp Beerbaum, MD · Evelina Children's Hospital, Guy's and St. Thomas Foundation Trust, Interdisciplinary Medical Imaging Group, King's College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-05-31
Completion
2012-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00564993 on ClinicalTrials.gov