Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot

Tetralogy of Fallot Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536432
• Other study ID #: MP 4.2
• Status: Completed
• Phase: N/A
• First received: September 26, 2007
• Last updated: June 5, 2012
• Start date: September 2007
• Est. completion date: June 2012

Study information

• Verified date: October 2010
• Source: Competence Network for Congenital Heart Defects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tetralogy of Fallot

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum Nordrhein-Westfalen	Bad Oeynhausen	North Rhine-Westphalia
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Universitätsklinikum Charite, Campus Virchow-Klinikum, Otto-Heubner-Centrum für Kinder- und Jugendmedizin	Berlin
Germany	Herzzentrum Duisburg, Kinderkardiologie	Duisburg	North Rhine-Westphalia
Germany	Universitätsklinikum Essen, Klinik für Kinderkardiologie	Essen	North Rhine-Westphalia
Germany	Universitätsklinikum Freiburg, Klinik III Päd. Kardiologie	Freiburg	Baden-Wuerttemberg
Germany	Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin	Hannover	Lower Saxony
Germany	Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie	Homburg/Saar	Saarland
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Kinderkardiologie	Kiel	Schleswig-Holstein
Germany	Herzzentrum Leipzig, Klinik für Kinderkardiologie	Leipzig	Saxony
Germany	Universitätsklinikum Muenster, Klinik für Kinderkardiologie	Muenster	North Rhine-Westphalia
Germany	Deutsches Herzzentrum Muenchen	Munich	Bavaria
Germany	Deutsches Kinderherzzentrum St. Augustin	Sankt Augustin	North Rhine-Westphalia
Germany	Universitätsklinikum Tuebingen, Klinik für Kinderheilkunde und Jugendmedizin	Tuebingen	Baden-Wuerttemberg

Sponsors (2)

Lead Sponsor	Collaborator
Competence Network for Congenital Heart Defects	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

External Links

•   click here for more information about the Competence Network for Congenital Heart Defects