Follow up of Post-repair 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:
NCT00266188
First received: December 15, 2005
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

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
Tetralogy of Fallot

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-invasive Imaging and Exercise Tolerance Tests in Post-repair Tetralogy of Fallot - Intervention and Course in Patients Over 8 Years Old

Resource links provided by NLM:


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

Primary Outcome Measures:
  • - Assessment of the biventricular function via MRI, colour Doppler echocardiography, tissue Doppler and strain-rate imaging in correlation with objective exercise tolerance
  • (spiroergometry)
  • - 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)

Enrollment: 406
Study Start Date: January 2005
Study Completion Date: June 2008
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-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.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient with tetralogy of Fallot

Criteria

Inclusion Criteria:

  • Written consent of the patient and/or the patient's legal representative
  • Patients with tetralogy of Fallot (including pulmonary atresia with extreme form of VSD ) after corrective operation
  • The corrective intervention has to date back to at least one year before study inclusion
  • Ergospirometry and MRI examination can be carried out on an outpatient basis (i. e. patients are normally older than 8 years)
  • Patients are not selected according to functional status, i. e. in terms of potentially necessary reintervention measures (e. g. cardiac catheter intervention, pulmonary valve replacement)

Exclusion Criteria:

  • Lack of consent
  • Tetralogy of Fallot or pulmonary atresia with VSD without corrective operation (or corrective operation that dates back to less than one year before)
  • Pulmonary valve agenesia, DORV (if there is a distinct discontinuity between mitral valve and aortic valve)
  • Associated severe heart defects (e. g. AV canal)
  • Other clinically relevant diseases, such as malignant tumour or florid diseases (in the investigating physician's assessment)
  • Patient is not able to perform ergospirometry (bicycle/treadmill) or contraindication exists
  • Absolute MRI contraindication, e.g. cardiac pacemaker
  • Pregnant and breast-feeding patients
  • Lack of cardiac catheter findings (or MRI) before initial operation -
  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: NCT00266188

Locations
Germany
Universitätsklinikum Tübingen
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
Herzzentrum Duisburg
Duisburg, North Rhine-Westphalia, Germany, D-47137
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany, D-45122
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, North Rhine-Westphalia, Germany, D-24105
Universitätsklinikum Muenster
Muenster, North Rhine-Westphalia, Germany, D-48149
Deutsches Kinderherzzentrum
Sankt Augustin, North Rhine-Westphalia, Germany, D-53757
Herzzentrum Leipzig
Leipzig, Saxony, Germany, D-04289
Universitätsklinikum Charité
Berlin, Germany, D-13353
Deutsches Herzzentrum Berlin
Berlin, Germany, D-13353
Herzzentrum Hamburg, UKE
Hamburg, Germany, D-29246
Sponsors and Collaborators
Competence Network for Congenital Heart Defects
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Samir Sarikouch, MD Herz- und Diabeteszentrum Nordrhein Westfalen
Study Chair: Philipp Beerbaum, MD Kings College London, Division of Imaging Sciences
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00266188     History of Changes
Other Study ID Numbers: MP 4.1, 01G10210
Study First Received: December 15, 2005
Last Updated: September 20, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Competence Network for Congenital Heart Defects:
Heart Defects, Congenital
Tetralogy of Fallot
Heart Septal Defects, Ventricular
Pulmonary Valve Diseases
Magnetic Resonance Imaging
Heart Catheterization
Echocardiography

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

ClinicalTrials.gov processed this record on July 26, 2014