Follow up of Post-repair Tetralogy of Fallot

September 20, 2011 updated by: Competence Network for Congenital Heart Defects

Non-invasive Imaging and Exercise Tolerance Tests in Post-repair Tetralogy of Fallot - Intervention and Course in Patients Over 8 Years Old

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

406

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, D-13353
        • Deutsches Herzzentrum Berlin
      • Berlin, Germany, D-13353
        • Universitätsklinikum Charité
      • Hamburg, Germany, D-29246
        • Herzzentrum Hamburg, UKE
    • Baden-Wuerttemberg
      • Tübingen, Baden-Wuerttemberg, Germany, D-72076
        • Universitätsklinikum Tübingen
    • Bavaria
      • Munich, Bavaria, Germany, D-80636
        • Deutsches Herzzentrum Muenchen
    • Lower Saxony
      • Hannover, Lower Saxony, Germany, D-30625
        • Medizinische Hochschule Hannover
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, D-52057
        • Universitätsklinikum RWTH Aachen
      • Bad Oeynhausen, North Rhine-Westphalia, Germany, D-32545
        • Herz-und Diabeteszentrum Nordrhein-Westfalen
      • Duisburg, North Rhine-Westphalia, Germany, D-47137
        • Herzzentrum Duisburg
      • Essen, North Rhine-Westphalia, Germany, D-45122
        • Universitätsklinikum Essen
      • Kiel, North Rhine-Westphalia, Germany, D-24105
        • Universitätsklinikum Schleswig-Holstein Campus Kiel
      • Muenster, North Rhine-Westphalia, Germany, D-48149
        • Universitätsklinikum Muenster
      • Sankt Augustin, North Rhine-Westphalia, Germany, D-53757
        • Deutsches Kinderherzzentrum
    • Saxony
      • Leipzig, Saxony, Germany, D-04289
        • Herzzentrum Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with tetralogy of Fallot

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Competence Network for Congenital Heart Defects

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Samir Sarikouch, MD, Heart and Diabetes Center North Rhine-Westphalia
  • Study Chair: Philipp Beerbaum, MD, Kings College London, Division of Imaging Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

December 15, 2005

First Submitted That Met QC Criteria

December 15, 2005

First Posted (Estimate)

December 16, 2005

Study Record Updates

Last Update Posted (Estimate)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 20, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP 4.1
  • 01G10210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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