Follow up of Post-repair Tetralogy of Fallot

NCT00266188 | Completed

• 2 other identifiers: MP 4.101G10210
• Study Type: observational
• Target: 406
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Tetralogy of Fallot

Keywords

Heart Defects, Congenital; Tetralogy of Fallot; Heart Septal Defects, Ventricular; Pulmonary Valve Diseases; Magnetic Resonance Imaging; Heart Catheterization; Echocardiography

Outcome Measures

Primary Outcomes (6)

• - 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)

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with tetralogy of Fallot

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Competence Network for Congenital Heart Defects: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (14)

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, D-72076, Germany

Location

Deutsches Herzzentrum Muenchen

Munich, Bavaria, D-80636, Germany

Location

Herzzentrum Hamburg, UKE

Hamburg, Hamburg, D-29246, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, D-30625, Germany

Location

Universitätsklinikum RWTH Aachen

Aachen, North Rhine-Westphalia, D-52057, Germany

Location

Herz-und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, North Rhine-Westphalia, D-32545, Germany

Location

Herzzentrum Duisburg

Duisburg, North Rhine-Westphalia, D-47137, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, D-45122, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, North Rhine-Westphalia, D-24105, Germany

Location

Universitätsklinikum Muenster

Münster, North Rhine-Westphalia, D-48149, Germany

Location

Deutsches Kinderherzzentrum

Sankt Augustin, North Rhine-Westphalia, D-53757, Germany

Location

Herzzentrum Leipzig

Leipzig, Saxony, D-04289, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, State of Berlin, D-13353, Germany

Location

Universitätsklinikum Charité

Berlin, State of Berlin, D-13353, Germany

Location

Related Publications (9)

• Sarikouch S, Koerperich H, Dubowy KO, Boethig D, Boettler P, Mir TS, Peters B, Kuehne T, Beerbaum P; German Competence Network for Congenital Heart Defects Investigators. Impact of gender and age on cardiovascular function late after repair of tetralogy of Fallot: percentiles based on cardiac magnetic resonance. Circ Cardiovasc Imaging. 2011 Nov;4(6):703-11. doi: 10.1161/CIRCIMAGING.111.963637. Epub 2011 Sep 9.

  PMID: 21908707 RESULT

• Mueller M, Rentzsch A, Hoetzer K, Raedle-Hurst T, Boettler P, Stiller B, Lemmer J, Sarikouch S, Beerbaum P, Peters B, Vogt M, Vogel M, Abdul-Khaliq H. Assessment of interventricular and right-intraventricular dyssynchrony in patients with surgically repaired tetralogy of Fallot by two-dimensional speckle tracking. Eur J Echocardiogr. 2010 Oct;11(9):786-92. doi: 10.1093/ejechocard/jeq067. Epub 2010 May 30.

  PMID: 20513701 RESULT

• Riesenkampff E, Mengelkamp L, Mueller M, Kropf S, Abdul-Khaliq H, Sarikouch S, Beerbaum P, Hetzer R, Steendijk P, Berger F, Kuehne T. Integrated analysis of atrioventricular interactions in tetralogy of Fallot. Am J Physiol Heart Circ Physiol. 2010 Aug;299(2):H364-71. doi: 10.1152/ajpheart.00264.2010. Epub 2010 May 21.

  PMID: 20495149 RESULT

• Beerbaum P, Barth P, Kropf S, Sarikouch S, Kelter-Kloepping A, Franke D, Gutberlet M, Kuehne T. Cardiac function by MRI in congenital heart disease: impact of consensus training on interinstitutional variance. J Magn Reson Imaging. 2009 Nov;30(5):956-66. doi: 10.1002/jmri.21948.

  PMID: 19856409 RESULT

• Bodhey NK, Beerbaum P, Sarikouch S, Kropf S, Lange P, Berger F, Anderson RH, Kuehne T. Functional analysis of the components of the right ventricle in the setting of tetralogy of Fallot. Circ Cardiovasc Imaging. 2008 Sep;1(2):141-7. doi: 10.1161/CIRCIMAGING.108.783795. Epub 2008 Jul 30.

  PMID: 19808531 RESULT

• Diller GP, Vahle J, Radke R, Vidal MLB, Fischer AJ, Bauer UMM, Sarikouch S, Berger F, Beerbaum P, Baumgartner H, Orwat S; German Competence Network for Congenital Heart Defects Investigators. Utility of deep learning networks for the generation of artificial cardiac magnetic resonance images in congenital heart disease. BMC Med Imaging. 2020 Oct 8;20(1):113. doi: 10.1186/s12880-020-00511-1.

  PMID: 33032536 DERIVED

• Orwat S, Diller GP, Kempny A, Radke R, Peters B, Kuhne T, Boethig D, Gutberlet M, Dubowy KO, Beerbaum P, Sarikouch S, Baumgartner H; German Competence Network for Congenital Heart Defects Investigators. Myocardial deformation parameters predict outcome in patients with repaired tetralogy of Fallot. Heart. 2016 Feb;102(3):209-15. doi: 10.1136/heartjnl-2015-308569. Epub 2015 Dec 29.

  PMID: 26715570 DERIVED

• Sarikouch S, Boethig D, Peters B, Kropf S, Dubowy KO, Lange P, Kuehne T, Haverich A, Beerbaum P; Investigators of the German Competence Network for Congenital Heart Defects. Poorer right ventricular systolic function and exercise capacity in women after repair of tetralogy of fallot: a sex comparison of standard deviation scores based on sex-specific reference values in healthy control subjects. Circ Cardiovasc Imaging. 2013 Nov;6(6):924-33. doi: 10.1161/CIRCIMAGING.112.000195. Epub 2013 Oct 16.

  PMID: 24132714 DERIVED

• Kutty S, Kuehne T, Gribben P, Reed E, Li L, Danford DA, Beerbaum PB, Sarikouch S. Ascending aortic and main pulmonary artery areas derived from cardiovascular magnetic resonance as reference values for normal subjects and repaired tetralogy of Fallot. Circ Cardiovasc Imaging. 2012 Sep 1;5(5):644-51. doi: 10.1161/CIRCIMAGING.112.973073. Epub 2012 Jun 22.

  PMID: 22730421 DERIVED

MeSH Terms

Conditions

Tetralogy of Fallot; Heart Defects, Congenital; Heart Septal Defects, Ventricular

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Septal Defects

Study Officials

• Samir Sarikouch, MD

  Heart and Diabetes Center North Rhine-Westphalia

  PRINCIPAL INVESTIGATOR

• Philipp Beerbaum, MD

  Kings College London, Division of Imaging Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 15, 2005
• First Posted: December 16, 2005
• Study Start: January 1, 2005
• Study Completion: June 1, 2008
• Last Updated: September 21, 2011

Record last verified: 2011-09

Locations

DE (14)