Tetralogy of FallotNCT00266188
Follow up of Post-repair 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 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Tetralogy of Fallot
- How many people
- 406 participants
- Where
- 14 sitesGermany
- Study dates
- Jan 2005to Jun 2008
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with tetralogy of Fallot
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Absolute MRI contraindication, e.g. cardiac pacemaker
- Pregnant and breast-feeding patients
- Lack of cardiac catheter findings (or MRI) before initial operation -
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Germany14 sites
Universitätsklinikum RWTH Aachen
Aachen, North Rhine-Westphalia, D-52057
Herz-und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, D-32545
Deutsches Herzzentrum Berlin
Berlin, State of Berlin, D-13353
Universitätsklinikum Charité
Berlin, State of Berlin, D-13353
Herzzentrum Duisburg
Duisburg, North Rhine-Westphalia, D-47137
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, D-45122
Herzzentrum Hamburg, UKE
Hamburg, Free and Hanseatic City of Hamburg, D-29246
Medizinische Hochschule Hannover
Hanover, Lower Saxony, D-30625
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, North Rhine-Westphalia, D-24105
Herzzentrum Leipzig
Leipzig, Saxony, D-04289
Deutsches Herzzentrum Muenchen
Munich, Bavaria, D-80636
Universitätsklinikum Muenster
Münster, North Rhine-Westphalia, D-48149
Deutsches Kinderherzzentrum
Sankt Augustin, North Rhine-Westphalia, D-53757
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, D-72076
About this study
Official title: 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.
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-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.
- Conditions
- Tetralogy of Fallot
- Keywords
- Heart Defects, Congenital, Tetralogy of Fallot, Heart Septal Defects, Ventricular, Pulmonary Valve Diseases, Magnetic Resonance Imaging, Heart Catheterization, Echocardiography
- Medical subject headings
- Tetralogy of Fallot, Heart Defects, Congenital, Heart Septal Defects, Ventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startJan 2005
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- 406 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, Heart and Diabetes Center North Rhine-WestphaliaPhilipp Beerbaum, MD, Study chair, Kings College London, Division of Imaging Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266188
- Sponsor's protocol ID
- MP 4.1
- Other IDs
- 01G10210
- Status last verified
- Sep 2011
- First submitted
- 15 Dec 2005
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21908707Mueller 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.
PubMed 20513701Riesenkampff 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.
PubMed 20495149Beerbaum 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.
PubMed 19856409Bodhey 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.
PubMed 19808531Diller 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.
PubMed 33032536Orwat 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.
PubMed 26715570Sarikouch 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.
PubMed 24132714Kutty 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.
PubMed 22730421
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Imaging and Exercise Tolerance Tests in Post-repair Tetralogy of Fallot - Intervention and Course in Patients Over 8 Years Old
- ClinicalTrials.gov ID
- NCT00266188
- Acronym / sponsor ID
- MP 4.1
- Conditions
- Tetralogy of Fallot
- Keywords
- Heart Defects, Congenital, Tetralogy of Fallot, Heart Septal Defects, Ventricular, Pulmonary Valve Diseases, Magnetic Resonance Imaging, Heart Catheterization, Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Competence Network for Congenital Heart DefectsOther government
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jan 2005
- Study completion
- Jun 2008 (actual)
- First posted
- 16 Dec 2005 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with tetralogy of Fallot
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
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
- 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)
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 21 Sep 2011.
- Results publication: PubMed 21908707Sarikouch 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.
- Results publication: PubMed 20513701Mueller 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.
- Results publication: PubMed 20495149Riesenkampff 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.
- Results publication: PubMed 19856409Beerbaum 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.
- Results publication: PubMed 19808531Bodhey 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.
- Derived from this study: PubMed 33032536Diller 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.
- Derived from this study: PubMed 26715570Orwat 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.
- Derived from this study: PubMed 24132714Sarikouch 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.
- Derived from this study: PubMed 22730421Kutty 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.
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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
Heart and Diabetes Center North Rhine-Westphalia
Philipp Beerbaum, MD study chair
Kings College London, Division of Imaging Sciences
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 5 inclusion and 9 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 21 Sep 2011. 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.
What does the primary outcome measure?
- Assessment of the biventricular function via MRI, colour Doppler echocardiography, tissue Doppler and strain-rate imaging in correlation with objective exercise tolerance. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00266188, which also lists 9 linked publications.
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 21 Sep 2011.