drugset / Trial / NCT00564993
Cardiac Function Under Stress for Early Detection of the Right Ventricular Insufficiency After Repair of Tetralogy of Fallot
Phase 3
Terminated
53 enrolled
Competence Network for Congenital Heart Defects
German Federal Ministry of Education and Research · collab
Non-randomizedParallel-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2007-11
- Primary completion
- 2011-05
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dobutamine | Small molecule | 10 ug/kg | — |
| Comparator | Dobutamine | Small molecule | 20 ug/kg | — |