Follow up of Post-repair Tetralogy of Fallot
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|ClinicalTrials.gov Identifier: NCT00266188|
Recruitment Status : Completed
First Posted : December 16, 2005
Last Update Posted : September 21, 2011
Tetralogy of Fallot is the most frequent complex congenital heart malformation. Over the past five decades, surgical repair has been performed with respectable results. However, relevant postoperative residues frequently remain. Pulmonary insufficiency, in particular, has been identified as a factor limiting the right ventricular function and, accordingly, the quality of life and life expectancy.
With increasing use of cardiac MRI for both measurement of ventricular function and imaging of pulmonary arteries, residual defects have been discovered that were not detectable by echocardiography. There is mounting evidence of right ventricular pressure and volume stress in Fallot patients after surgical correction. At present, it is impossible to detect right ventricular insufficiency at an early stage. Hence, it is to be assumed that right ventricular insufficiency is underdiagnosed and therapeutic action frequently is initiated beyond the point of no return of ventricular function.
The objective of this study is the systematic collection of cross-sectional and longitudinal data from extensive standardised examinations, including MRI, echocardiography, pulmonary function and ergometry tests, ECG and quality of life assessments, in a large number of patients with surgically corrected tetralogy of Fallot, and the setup of a database. The data obtained are supposed to provide information on the long-term outcome of surgical correction, to help establish criteria for necessity and time of re-intervention or re-operation, and to assess the effectiveness of re-interventions and re-operations.
|Condition or disease|
|Tetralogy of Fallot|
In the repair of tetralogy of Fallot, pulmonary insufficiency used to be tacitly accepted as a result of extensive transannular patching (TAP) and considered unobjectionable. In fact, this is well tolerated during the first postoperative years, but today there is increasing evidence that the resulting chronic volume stress to the right ventricle is harmful on the long run, in particular if there are stenoses of the pulmonary artery in addition. Such stenoses, partly due to distortions after shunt surgery, together with pulmonary insufficiency, lead to a combined volume and pressure load of the right ventricle. The chronic volume stress results in a decrease in biventricular function and exercise tolerance, associated with increasing electrical instability with frequent, mostly ventricular, dysrhythmias. This constellation brings about a significantly increased risk of cardiac death.
Pulmonary valve replacement can improve haemodynamics, exercise tolerance and dysrhythmia. However, it is still unclear, which criteria best indicate the need for re-operation or other re-intervention, such as balloon dilatations of peripheral pulmonary stenoses, and what may be the best point in time.
Cardiac MRI has been established as non-invasive method to quantify right and left ventricular function without radiation exposure. Correlating quantitative functional data to clinical conditions may permit the evaluation of factors that influence the long-term course after surgical repair of Fallot's tetralogy.
The objective of this study is to establish a broad database of cross-sectional and longitudinal (after one year) findings from extensive standardised examinations, including MRI, echocardiography, pulmonary function and ergometry tests, ECG, quality of life assessments performed and cardiac catheterisation, if indicated, on a large number of subjects with surgically corrected tetralogy of Fallot. The data obtained are supposed to determine parameters indicating beginning irreversibility of decreased cardiac function, to provide information on the long-term outcome of surgical correction, to help establish criteria for necessity and time of re-intervention or re-operation, and to assess the effectiveness of re-interventions and re-operations.
|Study Type :||Observational|
|Actual Enrollment :||406 participants|
|Official Title:||Non-invasive Imaging and Exercise Tolerance Tests in Post-repair Tetralogy of Fallot - Intervention and Course in Patients Over 8 Years Old|
|Study Start Date :||January 2005|
|Study Completion Date :||June 2008|
- - Assessment of the biventricular function via MRI, colour Doppler echocardiography, tissue Doppler and strain-rate imaging in correlation with objective exercise tolerance
- - Subjective quality of life
- - Prevalence of cardiac dysrhythmias
- - Mortality (above all in relapse interventions, such as interventional cardiac catheter or operation)
- - Morbidity (i. e. severe unwanted effects [SUE], particularly in relapse interventions, such as interventional cardiac catheter or operation)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266188
|Tübingen, Baden-Wuerttemberg, Germany, D-72076|
|Deutsches Herzzentrum Muenchen|
|Munich, Bavaria, Germany, D-80636|
|Medizinische Hochschule Hannover|
|Hannover, Lower Saxony, Germany, D-30625|
|Universitätsklinikum RWTH Aachen|
|Aachen, North Rhine-Westphalia, Germany, D-52057|
|Herz-und Diabeteszentrum Nordrhein-Westfalen|
|Bad Oeynhausen, North Rhine-Westphalia, Germany, D-32545|
|Duisburg, North Rhine-Westphalia, Germany, D-47137|
|Essen, North Rhine-Westphalia, Germany, D-45122|
|Universitätsklinikum Schleswig-Holstein Campus Kiel|
|Kiel, North Rhine-Westphalia, Germany, D-24105|
|Muenster, North Rhine-Westphalia, Germany, D-48149|
|Sankt Augustin, North Rhine-Westphalia, Germany, D-53757|
|Leipzig, Saxony, Germany, D-04289|
|Deutsches Herzzentrum Berlin|
|Berlin, Germany, D-13353|
|Berlin, Germany, D-13353|
|Herzzentrum Hamburg, UKE|
|Hamburg, Germany, D-29246|
|Principal Investigator:||Samir Sarikouch, MD||Heart and Diabetes Center North Rhine-Westphalia|
|Study Chair:||Philipp Beerbaum, MD||Kings College London, Division of Imaging Sciences|