Tetralogy of FallotNCT00536432
Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot
An observational study of Tetralogy of Fallot, run by Competence Network for Congenital Heart Defects at 14 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Tetralogy of Fallot
- How many people
- 93 participants
- Where
- 14 sitesGermany
- Study dates
- Sep 2007to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: children, <8 years, with tetralogy of Fallot
Who may be able to join
- 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 )
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Germany14 sites
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, D-32545
Deutsches Herzzentrum Berlin
Berlin, State of Berlin, D-13353
Universitätsklinikum Charite, Campus Virchow-Klinikum, Otto-Heubner-Centrum für Kinder- und Jugendmedizin
Berlin, State of Berlin, D-13353
Herzzentrum Duisburg, Kinderkardiologie
Duisburg, North Rhine-Westphalia, D-47137
Universitätsklinikum Essen, Klinik für Kinderkardiologie
Essen, North Rhine-Westphalia, D-45122
Universitätsklinikum Freiburg, Klinik III Päd. Kardiologie
Freiburg im Breisgau, Baden-Wurttemberg, D-79106
Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin
Hanover, Lower Saxony, D-30625
Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie
Homburg/Saar, Saarland, D-66421
Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Kinderkardiologie
Kiel, Schleswig-Holstein, D-24105
Herzzentrum Leipzig, Klinik für Kinderkardiologie
Leipzig, Saxony, D-04289
Deutsches Herzzentrum Muenchen
Munich, Bavaria, D-80636
Universitätsklinikum Muenster, Klinik für Kinderkardiologie
Münster, North Rhine-Westphalia, D-48149
Deutsches Kinderherzzentrum St. Augustin
Sankt Augustin, North Rhine-Westphalia, D-53757
Universitätsklinikum Tuebingen, Klinik für Kinderheilkunde und Jugendmedizin
Tübingen, Baden-Wurttemberg, D-72076
About this study
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
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.
Read the 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.
- Conditions
- Tetralogy of Fallot
- Medical subject headings
- Tetralogy of Fallot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Competence Network for Congenital Heart Defects
- Sponsor type
- Other government
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Samir Sarikouch, MD, Principal investigator, Medizinische Hochschule Hannover, Lower SaxonyPhilipp Beerbaum, MD, Study chair, Evelina Children's Hospital, Guy's and St. Thomas Foundation Trust, Interdisciplinary Medical Imaging Group, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536432
- Sponsor's protocol ID
- MP 4.2
- Status last verified
- Oct 2010
- First submitted
- 26 Sep 2007
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00536432
- Acronym / sponsor ID
- MP 4.2
- Conditions
- Tetralogy of Fallot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Competence Network for Congenital Heart DefectsOther government
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Sep 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children, <8 years, with tetralogy of Fallot
Key inclusion criteria (3 listed)
- 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 )
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
- click here for more information about the Competence Network for Congenital Heart DefectsLink provided by the sponsor.
Related trials for Tetralogy of Fallot
RecruitingPhase 4
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
RecruitingPhase 1
Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
Active, not recruiting
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
RecruitingObservational study
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Tetralogy of Fallot (TOF), Congenital Heart Defects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Sarikouch, MD principal investigator
Medizinische Hochschule Hannover, Lower Saxony
Philipp Beerbaum, MD study chair
Evelina Children's Hospital, Guy's and St. Thomas Foundation Trust, Interdisciplinary Medical Imaging Group, King's College London
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tetralogy of Fallot, run by Competence Network for Congenital Heart Defects at 14 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2012.