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

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Competence Network for Congenital Heart Defects
ClinicalTrials.gov Identifier:
NCT00536432
First received: September 26, 2007
Last updated: June 5, 2012
Last verified: October 2010
  Purpose

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.


Condition
Tetralogy of Fallot

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Competence Network for Congenital Heart Defects:

Enrollment: 93
Study Start Date: September 2007
Study Completion Date: June 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   up to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

children, <8 years, with tetralogy of Fallot

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536432

Locations
Germany
Universitätsklinikum Freiburg, Klinik III Päd. Kardiologie
Freiburg, Baden-Wuerttemberg, Germany, D-79106
Universitätsklinikum Tuebingen, Klinik für Kinderheilkunde und Jugendmedizin
Tuebingen, Baden-Wuerttemberg, Germany, D-72076
Deutsches Herzzentrum Muenchen
Munich, Bavaria, Germany, D-80636
Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin
Hannover, Lower Saxony, Germany, D-30625
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, Germany, D-32545
Herzzentrum Duisburg, Kinderkardiologie
Duisburg, North Rhine-Westphalia, Germany, D-47137
Universitätsklinikum Essen, Klinik für Kinderkardiologie
Essen, North Rhine-Westphalia, Germany, D-45122
Universitätsklinikum Muenster, Klinik für Kinderkardiologie
Muenster, North Rhine-Westphalia, Germany, D-48149
Deutsches Kinderherzzentrum St. Augustin
Sankt Augustin, North Rhine-Westphalia, Germany, D-53757
Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie
Homburg/Saar, Saarland, Germany, D-66421
Herzzentrum Leipzig, Klinik für Kinderkardiologie
Leipzig, Saxony, Germany, D-04289
Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Kinderkardiologie
Kiel, Schleswig-Holstein, Germany, D-24105
Universitätsklinikum Charite, Campus Virchow-Klinikum, Otto-Heubner-Centrum für Kinder- und Jugendmedizin
Berlin, Germany, D-13353
Deutsches Herzzentrum Berlin
Berlin, Germany, D-13353
Sponsors and Collaborators
Competence Network for Congenital Heart Defects
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Samir Sarikouch, MD Medizinische Hochschule Hannover, Lower Saxony
Study Chair: Philipp Beerbaum, MD Evelina Children's Hospital, Guy's and St. Thomas Foundation Trust, Interdisciplinary Medical Imaging Group, King's College London
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00536432     History of Changes
Other Study ID Numbers: MP 4.2
Study First Received: September 26, 2007
Last Updated: June 5, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Tetralogy of Fallot
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 18, 2014