Clinical trial NCT00536432: Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot
Official title: Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot: Prospective Analysis of Myocardial Benefit Using Cardiac MRI and Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tetralogy of Fallot
Lead sponsor: Competence Network for Congenital Heart Defects
Sponsor class: OTHER_GOV
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2007-09-27
Enrollment: 93
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children, \<8 years, with tetralogy of Fallot

Brief summary: Tetralogy of Fallot is one of the most frequent congenital heart malformations. In many cases re-interventions, surgical or catheter-based, are necessary after the repair of tetralogy of Fallot in infancy. At present, informations in the literature about the myocardial benefit and the timing of re-interventions are missing in this age group. On the other hand, Fallot patients are dependent on solid criteria for re-interventions, because further interventions like replacement of the pulmonary valve or balloon dilatations of peripheral pulmonary stenoses are common.

The objective of this study is to assess the benefit of such interventions for the right ventricular function. By performing extensive standardised examinations (including MRI, echocardiography, tissue Doppler,,3D-echocardiography, holter monitoring and quality of life assessments) before and 6 to 9 months after the re-intervention data of the right ventricular function are collected. Based on these quantitative data predictive parameters concerning the right ventricular recovery and information about the time of re-intervention should be determined.

Detailed description: 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-intervention, such as balloon dilatations of peripheral pulmonary stenoses, and what may be the best point in time in infancy.

The objective of this study is to assess the effectiveness of such interventions to the right ventricular function in small children. The data obtained are supposed to determine predictive parameters of the right ventricular recovery and to help to establish criteria for the necessity and time of re-intervention.

Eligibility criteria: Inclusion Criteria:

* Written informed consent of the patient's legal representatives
* Patients with tetralogy of Fallot (including pulmonary atresia with vsd) after corrective operation
* Patients \< 8 years with corrective surgery and necessary re-intervention (e.g.cardiac catheter intervention or re-operation )

Exclusion Criteria:

* DORV (if there is another VSD than subaortic)
* Associated severe heart defects (e. g. AV canal)
* Other clinically relevant diseases, such as malignant tumor (in the investigating physician's assessment)
* MRI contraindication, e.g. cardiac pacemaker, implanted neurostimulators and other magnetizable foreign bodies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Klinik III Päd. Kardiologie
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: Universitätsklinikum Tuebingen, Klinik für Kinderheilkunde und Jugendmedizin
state: Baden-Wuerttemberg
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
state: Bavaria
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin
state: Lower Saxony
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen
state: North Rhine-Westphalia
city: Duisburg
country: Germany
facility: Herzzentrum Duisburg, Kinderkardiologie
state: North Rhine-Westphalia
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Klinik für Kinderkardiologie
state: North Rhine-Westphalia
city: Muenster
country: Germany
facility: Universitätsklinikum Muenster, Klinik für Kinderkardiologie
state: North Rhine-Westphalia
city: Sankt Augustin
country: Germany
facility: Deutsches Kinderherzzentrum St. Augustin
state: North Rhine-Westphalia
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie
state: Saarland
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig, Klinik für Kinderkardiologie
state: Saxony
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Kinderkardiologie
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Berlin
country: Germany
facility: Universitätsklinikum Charite, Campus Virchow-Klinikum, Otto-Heubner-Centrum für Kinder- und Jugendmedizin
Study officials:
affiliation: Medizinische Hochschule Hannover, Lower Saxony
name: Samir Sarikouch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Evelina Children's Hospital, Guy's and St. Thomas Foundation Trust, Interdisciplinary Medical Imaging Group, King's College London
name: Philipp Beerbaum, MD
role: STUDY_CHAIR
References: