Tetralogy of FallotNCT03470064
Early Right Ventricular Function After Repair Of Tetralogy Of Fallot , An Evidence Based Study.
An observational study of Tetralogy of Fallot, run by Assiut University at 2 sites in Egypt.
Trial summary
This study aims to assessing right ventricular function early after surgical repair of tetralogy of Fallot and identifying the risk factors associated with development of RV dysfunction. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Tetralogy of Fallot
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Apr 2018to 1 Oct 2022
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: 1. Pediatric patients up to 12 years old. 2. Recent echocardiography before the surgery giving detailed data about the components congenital anomalies of tetralogy of Fallot and if there are other associated congenital anomalies. 3. Obtaining written informed consent from parents or guardians of all patients confirming their willing and comply with study requirements 4. Parents or guardians of the Patient are willing to comply with all follow-up visits
Who may be able to join
- Pediatric patients up to 12 years old.
- Recent echocardiography before the surgery giving detailed data about the components congenital anomalies of tetralogy of Fallot and if there are other associated congenital anomalies.
- Obtaining written informed consent from parents or guardians of all patients confirming their willing and comply with study requirements
- Parents or guardians of the Patient are willing to comply with all follow-up visits.
Who cannot join
- Patients with tetralogy of Fallot who are indicated to palliative procedures and not for definitive surgical repair as in case of:-
- Neonates with TOF and pulmonary atresia
- Children with hypoplastic pulmonary artery
- Age less than 3 months who have medically unmanageable hypoxic spells
- Infant weight less than 2.5 kg
- Abnormal coronary artery anatomy
Show all 13Show fewer
- Patients with TOF who are contraindicated to primary repair as in case of:-
- Multiple VSDs
- Multiple coexisting intracardiac malformations
- Small pulmonary arteries
- Very low birth weight
- The presence of an anomalous coronary artery
- Patient inaccessible for follow-up visits required by protocol.
Trial locations and contacts
2 sites in 1 country.
Zahran contact
Egypt2 sites, 2 recruiting
- Not yet recruiting
Assiut University
Asyut, 71515
ehab zahran, MSc, 002/01220589292, dr.ehabzahran@gmail.com
faculty of medicine faculty of medicine-assiut university
- Recruiting
Assiut University
Asyut
ehab zahran, MSc, 002/01220589292, dr.ehabzahran@gmail.com
faculty of medicine faculty of medicine-assiut university hospital, ehabzahran098@gmail.com
About this study
This study aims to assessing right ventricular function early after surgical repair of tetralogy of Fallot and identifying the risk factors associated with development of RV dysfunction.
Read the detailed description
The shape of the RV is dramatically modified by surgical repair of CHD, with infundibular bulging and apical dilation and deformation, leading to a large range of RV shapes(1,2). Moreover, pericardial section and suture during surgery influence RV geometry, as RV is normally more con-strained by the pericardium then the LV because of its thinner wall (3).
Intra cardiac repair(ICR) is the definitive management of TOF. Refinement in surgical techniques, advancements in anaesthetic \& critical care has resulted in improving survival following ICR. Post operative mortality following ICR is reported between 1% - 5% (3). Post operative low cardiac output and mortality has been attributed to many factors such as anatomical defects with small main pulmonary artery annulus, severe hypoplasia or absent right or left pulmonary artery, ventriculotomy and right ventricular (RV) outflow patch, myocardial hypoxia during cardiopulmonary bypass, or ARDS (4). Certain patients despite satisfactory ICR exhibit difficult post operative course which is characterized by prolonged ventilation \& inotropic support. These patients have been identified to exhibit features of RV dysfunction (low cardiac output, high central venous filling pressure, increased inotropic requirement, and prolonged ventilation). Identification of risk factors to characterise this subset of patients allows for better allocation of hospital resources, improved outcome, and substantially reduced hospital costs. This study will try to identify the risk factors associated with development of RV dysfunction \& its course over a period of three months in patients of tetralogy following ICR.
MRI is a gold standard for assessment of right ventricular function (5). However, MRI has restricted availability, is costly, and there are many patients in whom MRI-non compatible devices prohibit its use.
Because of its complex shape, there is no geometrical assumption that can allow quantification of RV volumes and ejection fraction (RVEF) by standard two-dimensional (2D) echocardiography. For this reason, surrogate parameters of RV systolic function are used most frequently to assess RV systolic function, because they are easy to measure, feasible and reproducible. These parameters include:-
- Tricuspid annulus movement:- Measurements of tricuspid annulus movement by M-mode (tricuspid annular plane systolic excursion [TAPSE]) or tissue Doppler imaging (peak systolic velocity [PSV]) are used most frequently to assess RV function; they are highly feasible and reproducible. However, several studies have shown their dependence on loading condition; TAPSE and PSV values are increased in volume overload and decreased in pressure overload (6), independent of RVEF.
-2D global longitudinal peak systolic strain of the RV lateral wall:- Speckle-tracking echocardiography is a new technology that allows quantification of myocardial regional deformation. The main advantage compared with tissue Doppler imaging is its angle independency; it was also thought to be less load dependent, but further studies demonstrated that 2D longitudinal strain values increase in volume overload and decrease in barometric overload (7).
- Isovolumic acceleration time(IVA):- Is a quantitative assessment of RV contractile function that is supposed to be unaffected by RV geometry or loading conditions. In patients with tetralogy of Fallot, studies have shown a good correlation between pulmonary regurgitation severity and IVA (8,9).
-Myocardial performance index :- Myocardial performance index (MPI) is another tissue Doppler-derived parameter of RV systolic function. MPI is calculated using the following formula: MPI =(isovolumic contraction time + isovolumic relaxation time)/ejection time (10).
- Fractional area change:- FAC has been shown to correlate well with RVEF measured by MRI in the general population (10).
- Conditions
- Tetralogy of Fallot
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RV Dysfunction | All pediatric patients who present to pediatric cardiothoracic unit, Assiut University Hospital and who meet the listed inclusion and exclusion criteria will be eligible for the study. Patients' charts will be retrieved based on their surgical procedures. The charts will be reviewed and eligible patients will be filtered. The needed variables will be entered into our data base for later data analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of RV function early after surgical repair of tetralogy of fallot
the study aim to assess the function of the Right ventricle early after surgical repair of tetralogy of fallot by echocardiography.
Measured: within one week postoperative
Secondary outcomes (1)
Follow up the course of RV function over a period of three months in patients of tetralogy of fallot following surgical repair .
the study aim to follow up the function of the Right ventricle after surgical repair of tetralogy of fallot by echocardiography
Measured: 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ehab abd-alaal zahran, Assiut University
- Investigators
- Ehab Zahran, PHD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470064
- Sponsor's protocol ID
- 17200175
- Status last verified
- Jul 2022
- First submitted
- 3 Mar 2018
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study aims to assessing right ventricular function early after surgical repair of tetralogy of Fallot and identifying the risk factors associated with development of RV dysfunction.
Publications
Tamborini G, Muratori M, Brusoni D, Celeste F, Maffessanti F, Caiani EG, Alamanni F, Pepi M. Is right ventricular systolic function reduced after cardiac surgery? A two- and three-dimensional echocardiographic study. Eur J Echocardiogr. 2009 Jul;10(5):630-4. doi: 10.1093/ejechocard/jep015. Epub 2009 Feb 27.
PubMed 19252190Eroglu AG, Sarioglu A, Sarioglu T. Right ventricular diastolic function after repair of tetralogy of Fallot: its relationship to the insertion of a 'transannular' patch. Cardiol Young. 1999 Jul;9(4):384-91.
PubMed 10476828Higgins CB. Which standard has the gold? J Am Coll Cardiol. 1992 Jun;19(7):1608-9. doi: 10.1016/0735-1097(92)90626-x. No abstract available.
PubMed 1534338Carminati M, Pluchinotta FR, Piazza L, Micheletti A, Negura D, Chessa M, Butera G, Arcidiacono C, Saracino A, Bussadori C. Echocardiographic assessment after surgical repair of tetralogy of fallot. Front Pediatr. 2015 Feb 2;3:3. doi: 10.3389/fped.2015.00003. eCollection 2015.
PubMed 25699243Jategaonkar SR, Scholtz W, Butz T, Bogunovic N, Faber L, Horstkotte D. Two-dimensional strain and strain rate imaging of the right ventricle in adult patients before and after percutaneous closure of atrial septal defects. Eur J Echocardiogr. 2009 Jun;10(4):499-502. doi: 10.1093/ejechocard/jen315. Epub 2009 Jan 20.
PubMed 19155264Frigiola A, Redington AN, Cullen S, Vogel M. Pulmonary regurgitation is an important determinant of right ventricular contractile dysfunction in patients with surgically repaired tetralogy of Fallot. Circulation. 2004 Sep 14;110(11 Suppl 1):II153-7. doi: 10.1161/01.CIR.0000138397.60956.c2.
PubMed 15364855Eidem BW, O'Leary PW, Tei C, Seward JB. Usefulness of the myocardial performance index for assessing right ventricular function in congenital heart disease. Am J Cardiol. 2000 Sep 15;86(6):654-8. doi: 10.1016/s0002-9149(00)01047-x.
PubMed 10980218Anavekar NS, Gerson D, Skali H, Kwong RY, Yucel EK, Solomon SD. Two-dimensional assessment of right ventricular function: an echocardiographic-MRI correlative study. Echocardiography. 2007 May;24(5):452-6. doi: 10.1111/j.1540-8175.2007.00424.x.
PubMed 17456062Wheeler M, Leipsic J, Trinh P, Raju R, Alaamri S, Thompson CR, Moss R, Munt B, Kiess M, Grewal J. Right Ventricular Assessment in Adult Congenital Heart Disease Patients with Right Ventricle-to-Pulmonary Artery Conduits. J Am Soc Echocardiogr. 2015 May;28(5):522-32. doi: 10.1016/j.echo.2014.11.016. Epub 2015 Jan 30.
PubMed 25648672Leonardi B, Taylor AM, Mansi T, Voigt I, Sermesant M, Pennec X, Ayache N, Boudjemline Y, Pongiglione G. Computational modelling of the right ventricle in repaired tetralogy of Fallot: can it provide insight into patient treatment? Eur Heart J Cardiovasc Imaging. 2013 Apr;14(4):381-6. doi: 10.1093/ehjci/jes239. Epub 2012 Nov 20.
PubMed 23169758
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Right Ventricular Function After Repair Of Tetralogy Of Fallot , An Evidence Based Study.
- ClinicalTrials.gov ID
- NCT03470064
- Acronym / sponsor ID
- 17200175
- Conditions
- Tetralogy of Fallot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 19 Mar 2018 (actual)
- 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.
This study aims to assessing right ventricular function early after surgical repair of tetralogy of Fallot and identifying the risk factors associated with development of RV dysfunction.
Detailed description
The shape of the RV is dramatically modified by surgical repair of CHD, with infundibular bulging and apical dilation and deformation, leading to a large range of RV shapes(1,2). Moreover, pericardial section and suture during surgery influence RV geometry, as RV is normally more con-strained by the pericardium then the LV because of its thinner wall (3).
Intra cardiac repair(ICR) is the definitive management of TOF. Refinement in surgical techniques, advancements in anaesthetic \& critical care has resulted in improving survival following ICR. Post operative mortality following ICR is reported between 1% - 5% (3). Post operative low cardiac output and mortality has been attributed to many factors such as anatomical defects with small main pulmonary artery annulus, severe hypoplasia or absent right or left pulmonary artery, ventriculotomy and right ventricular (RV) outflow patch, myocardial hypoxia during cardiopulmonary bypass, or ARDS (4). Certain patients despite satisfactory ICR exhibit difficult post operative course which is characterized by prolonged ventilation \& inotropic support. These patients have been identified to exhibit features of RV dysfunction (low cardiac output, high central venous filling pressure, increased inotropic requirement, and prolonged ventilation). Identification of risk factors to characterise this subset of patients allows for better allocation of hospital resources, improved outcome, and substantially reduced hospital costs. This study will try to identify the risk factors associated with development of RV dysfunction \& its course over a period of three months in patients of tetralogy following ICR.
MRI is a gold standard for assessment of right ventricular function (5). However, MRI has restricted availability, is costly, and there are many patients in whom MRI-non compatible devices prohibit its use.
Because of its complex shape, there is no geometrical assumption that can allow quantification of RV volumes and ejection fraction (RVEF) by standard two-dimensional (2D) echocardiography. For this reason, surrogate parameters of RV systolic function are used most frequently to assess RV systolic function, because they are easy to measure, feasible and reproducible. These parameters include:-
- Tricuspid annulus movement:- Measurements of tricuspid annulus movement by M-mode (tricuspid annular plane systolic excursion [TAPSE]) or tissue Doppler imaging (peak systolic velocity [PSV]) are used most frequently to assess RV function; they are highly feasible and reproducible. However, several studies have shown their dependence on loading condition; TAPSE and PSV values are increased in volume overload and decreased in pressure overload (6), independent of RVEF.
-2D global longitudinal peak systolic strain of the RV lateral wall:- Speckle-tracking echocardiography is a new technology that allows quantification of myocardial regional deformation. The main advantage compared with tissue Doppler imaging is its angle independency; it was also thought to be less load dependent, but further studies demonstrated that 2D longitudinal strain values increase in volume overload and decrease in barometric overload (7).
- Isovolumic acceleration time(IVA):- Is a quantitative assessment of RV contractile function that is supposed to be unaffected by RV geometry or loading conditions. In patients with tetralogy of Fallot, studies have shown a good correlation between pulmonary regurgitation severity and IVA (8,9).
-Myocardial performance index :- Myocardial performance index (MPI) is another tissue Doppler-derived parameter of RV systolic function. MPI is calculated using the following formula: MPI =(isovolumic contraction time + isovolumic relaxation time)/ejection time (10).
- Fractional area change:- FAC has been shown to correlate well with RVEF measured by MRI in the general population (10).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RV Dysfunction | – | –All pediatric patients who present to pediatric cardiothoracic unit, Assiut University Hospital and who meet the listed inclusion and exclusion criteria will be eligible for the study. Patients' charts will be retrieved based on their surgical procedures. The charts will be reviewed and eligible patients will be filtered. The needed variables will be entered into our data base for later data analysis |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 1. Pediatric patients up to 12 years old. 2. Recent echocardiography before the surgery giving detailed data about the components congenital anomalies of tetralogy of Fallot and if there are other associated congenital anomalies. 3. Obtaining written informed consent from parents or guardians of all patients confirming their willing and comply with study requirements 4. Parents or guardians of the Patient are willing to comply with all follow-up visits
Key inclusion criteria (4 listed)
- Pediatric patients up to 12 years old.
- Recent echocardiography before the surgery giving detailed data about the components congenital anomalies of tetralogy of Fallot and if there are other associated congenital anomalies.
- Obtaining written informed consent from parents or guardians of all patients confirming their willing and comply with study requirements
- Parents or guardians of the Patient are willing to comply with all follow-up visits.
Key exclusion criteria (13 listed)
- Patients with tetralogy of Fallot who are indicated to palliative procedures and not for definitive surgical repair as in case of:-
- Patients with TOF who are contraindicated to primary repair as in case of:-
- Patient inaccessible for follow-up visits required by protocol.
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 RV function early after surgical repair of tetralogy of fallot
Time frame: within one week postoperative
the study aim to assess the function of the Right ventricle early after surgical repair of tetralogy of fallot by echocardiography.
1 secondary outcome
Follow up the course of RV function over a period of three months in patients of tetralogy of fallot following surgical repair .
Time frame: 3 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background: PubMed 19252190Tamborini G, Muratori M, Brusoni D, Celeste F, Maffessanti F, Caiani EG, Alamanni F, Pepi M. Is right ventricular systolic function reduced after cardiac surgery? A two- and three-dimensional echocardiographic study. Eur J Echocardiogr. 2009 Jul;10(5):630-4. doi: 10.1093/ejechocard/jep015. Epub 2009 Feb 27.
- Background: PubMed 10476828Eroglu AG, Sarioglu A, Sarioglu T. Right ventricular diastolic function after repair of tetralogy of Fallot: its relationship to the insertion of a 'transannular' patch. Cardiol Young. 1999 Jul;9(4):384-91.
- Background: PubMed 1534338Higgins CB. Which standard has the gold? J Am Coll Cardiol. 1992 Jun;19(7):1608-9. doi: 10.1016/0735-1097(92)90626-x. No abstract available.
- Background: PubMed 25699243Carminati M, Pluchinotta FR, Piazza L, Micheletti A, Negura D, Chessa M, Butera G, Arcidiacono C, Saracino A, Bussadori C. Echocardiographic assessment after surgical repair of tetralogy of fallot. Front Pediatr. 2015 Feb 2;3:3. doi: 10.3389/fped.2015.00003. eCollection 2015.
- Background: PubMed 19155264Jategaonkar SR, Scholtz W, Butz T, Bogunovic N, Faber L, Horstkotte D. Two-dimensional strain and strain rate imaging of the right ventricle in adult patients before and after percutaneous closure of atrial septal defects. Eur J Echocardiogr. 2009 Jun;10(4):499-502. doi: 10.1093/ejechocard/jen315. Epub 2009 Jan 20.
- Background: PubMed 15364855Frigiola A, Redington AN, Cullen S, Vogel M. Pulmonary regurgitation is an important determinant of right ventricular contractile dysfunction in patients with surgically repaired tetralogy of Fallot. Circulation. 2004 Sep 14;110(11 Suppl 1):II153-7. doi: 10.1161/01.CIR.0000138397.60956.c2.
- Background: PubMed 10980218Eidem BW, O'Leary PW, Tei C, Seward JB. Usefulness of the myocardial performance index for assessing right ventricular function in congenital heart disease. Am J Cardiol. 2000 Sep 15;86(6):654-8. doi: 10.1016/s0002-9149(00)01047-x.
- Background: PubMed 17456062Anavekar NS, Gerson D, Skali H, Kwong RY, Yucel EK, Solomon SD. Two-dimensional assessment of right ventricular function: an echocardiographic-MRI correlative study. Echocardiography. 2007 May;24(5):452-6. doi: 10.1111/j.1540-8175.2007.00424.x.
- Background: PubMed 25648672Wheeler M, Leipsic J, Trinh P, Raju R, Alaamri S, Thompson CR, Moss R, Munt B, Kiess M, Grewal J. Right Ventricular Assessment in Adult Congenital Heart Disease Patients with Right Ventricle-to-Pulmonary Artery Conduits. J Am Soc Echocardiogr. 2015 May;28(5):522-32. doi: 10.1016/j.echo.2014.11.016. Epub 2015 Jan 30.
- Background: PubMed 23169758Leonardi B, Taylor AM, Mansi T, Voigt I, Sermesant M, Pennec X, Ayache N, Boudjemline Y, Pongiglione G. Computational modelling of the right ventricle in repaired tetralogy of Fallot: can it provide insight into patient treatment? Eur Heart J Cardiovasc Imaging. 2013 Apr;14(4):381-6. doi: 10.1093/ehjci/jes239. Epub 2012 Nov 20.
- Individual participant dataSharing planned: Undecided. This study aims to assessing right ventricular function early after surgical repair of tetralogy of Fallot and identifying the risk factors associated with development of RV dysfunction.
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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.
Zahran contact
Ehab Zahran, PHD principal investigator
Assiut University
2 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 Assiut University at 2 sites in Egypt.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ehab Zahran, PHD (00201220589292, dr.ehabzahran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of RV function early after surgical repair of tetralogy of fallot (time frame: within one week postoperative). 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 NCT03470064, which also lists 10 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 Jul 2022.