TOFNCT07010510
Quality of Life in Operated Adult Patients With Tetralogy of Fallot and Correlation With Myocardial Strain Analysis by CMR
An observational study of TOF, run by Assiut University.
Trial summary
Title: Functional Assessment and Arrhythmia Prediction in Adult Patients with Repaired Tetralogy of Fallot Using a Multimodality Approach Background: Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TOF
- What is being tested?
- CMR, stress ECG, Holter, BnP
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult patients (age ≥18 years) with previously repaired Tetralogy of Fallot (TOF), who were referred for routine clinical follow-up at least 3 months post-surgical correction. These patients underwent standard evaluations including cardiovascular magnetic resonance (CMR), transthoracic echocardiography, ECG, Holter monitoring, NT-proBNP measurement, and exercise stress testing. Patients were either in sinus rhythm or had a documented history of ventricular arrhythmia. Individuals with other major congenital heart defects, significant valvular disease, or contraindications to CMR were excluded.
Who may be able to join
- Adult TOF patients who were referred for surgical repair of TOF either valve sparing repair (VSR) or valved conduit (stented valve conduits, freestyle valved conduits, bio-prosthesis, or homograft).
- Adults (age ≥18 years) with repaired TOF.
- Undergoing routine CMR for clinical follow-up.
- Sinus rhythm or known history of ventricular arrhythmia.
Who cannot join
- Confounding other congenital defects e.g. AV canal.
- Significant aortic regurgitation or stenosis.
- Significant mitral regurgitation.
- Residual significant major aorto-pulmonary collaterals (MAPCAs).
- Patients with contraindications to CMR (e.g., pacemakers, severe renal impairment, claustrophobic).
- Poor-quality CMR images precluding strain analysis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Quality of Life in Operated Adult Patients With Tetralogy of Fallot and Correlation With Myocardial Strain Analysis by Cardiac Magnetic Resonance Imaging and Exercise Test
Title:
Functional Assessment and Arrhythmia Prediction in Adult Patients with Repaired Tetralogy of Fallot Using a Multimodality Approach
Read more
Background:
Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect. Surgical repair has improved survival into adulthood, but long-term complications like arrhythmias and heart failure remain common. Assessing health-related quality of life (HRQOL) and cardiac function is essential.
Aim:
Assess functional status of adult patients with repaired TOF using a multimodal approach, including myocardial strain analysis via CMR.
Identify predictors of arrhythmia using strain and clinical parameters.
Methods:
Design: Prospective observational study over one year.
Population: Adults (≥18 years) with repaired TOF undergoing follow-up CMR.
Assessments:
Clinical evaluation (NYHA class)
Echocardiography (RV size, function, valve status)
Laboratory tests (BNP, NT-proBNP)
Exercise testing (METs, VO₂ max)
ECG \& 24-hour Holter monitoring (QRS duration, arrhythmias)
CMR (volumes, flow, fibrosis, strain analysis of RA, RV, LV)
Outcomes:
Primary: Functional assessment of repaired TOF patients.
Secondary: Detection of arrhythmia and need for further interventions (e.g., ICD or ablation).
Statistical Analysis:
Comparison between arrhythmic and non-arrhythmic groups.
Logistic regression for predictors of arrhythmia.
ROC analysis to determine optimal strain cut-off values.
Ethical Considerations:
Ethics committee approval and informed consent.
Data confidentiality maintained.
- Conditions
- TOF
- Being tested
- CMR, stress ECG, Holter, BnP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMR, stress ECG, Holter, BnPDiagnostic test
This study involves no experimental intervention. All data were collected retrospectively from patients with repaired Tetralogy of Fallot (TOF) who underwent standard clinical follow-up. As part of routine care, patients received comprehensive multimodal functional assessment, including:
Cardiac Magnetic Resonance Imaging (CMR) with feature-tracking strain analysis
Transthoracic Echocardiography
Exercise stress testing (treadmill ECG using Bruce protocol)
12-lead ECG and 24-hour Holter monitoring
Laboratory evaluation including NT-proBNP levels
NYHA functional class assessment
| Study group | Role | What they receive |
|---|---|---|
| Patients with TOF | The study cohort consists of adult patients (≥18 years) with previously repaired Tetralogy of Fallot (TOF) who underwent routine clinical follow-up, including cardiac imaging, functional testing, and laboratory investigations. Patients included underwent surgical repair using either valve-sparing techniques or valved conduits and had follow-up assessments performed at least 3 months post-surgery. Data will be retrospectively collected from medical records, imaging databases, and clinical documentation. The cohort includes patients in sinus rhythm or with a documented history of ventricular arrhythmia, all of whom were referred for routine cardiovascular magnetic resonance (CMR) imaging and other functional assessments as part of standard care. Receives: Diagnostic Test: CMR, stress ECG, Holter, BnP |
What is being measured
The primary outcome is the main question the study is designed to answer.
NYHA Class
New York Heart Association (NYHA) classification 1 to 4
Measured: 1 year
cardiac magnetic resonance (CMR)
myocardial strain parameters
Measured: 1 years
Exercise capacity (METs)
Functional capacity 1-15
Measured: 1 years
NT-proBNP levels
Mg/dl
Measured: 1 yeqrs
Secondary outcomes (1)
Incidence of Arrhythmia in Adults with Repaired Tetralogy of Fallot (TOF)
Identification and documentation of arrhythmias based on standard 12-lead ECG and 24-hour Holter monitoring. Includes detection of premature ventricular contractions (PVCs), sustained or non-sustained ventricular tachycardia (VT), atrial flutter, atrial fibrillation, or other clinically significant arrhythmias requiring intervention.
Measured: At time of most recent follow-up (minimum 3 months post-surgical repair)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TOFStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdelrahman Abdelgaber Abdelhafez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010510
- Sponsor's protocol ID
- QOL in TOF
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villafane J, Feinstein JA, Jenkins KJ, Vincent RN, Walsh EP, Dubin AM, Geva T, Towbin JA, Cohen MS, Fraser C, Dearani J, Rosenthal D, Kaufman B, Graham TP Jr; Adult Congenital and Pediatric Cardiology Section, American College of Cardiology. Hot topics in tetralogy of Fallot. J Am Coll Cardiol. 2013 Dec 10;62(23):2155-66. doi: 10.1016/j.jacc.2013.07.100. Epub 2013 Sep 27.
PubMed 24076489Carvalho JS, Shinebourne EA, Busst C, Rigby ML, Redington AN. Exercise capacity after complete repair of tetralogy of Fallot: deleterious effects of residual pulmonary regurgitation. Br Heart J. 1992 Jun;67(6):470-3. doi: 10.1136/hrt.67.6.470.
PubMed 1622697Steinmetz M, Stumpfig T, Seehase M, Schuster A, Kowallick J, Muller M, Unterberg-Buchwald C, Kutty S, Lotz J, Uecker M, Paul T. Impaired Exercise Tolerance in Repaired Tetralogy of Fallot Is Associated With Impaired Biventricular Contractile Reserve: An Exercise-Stress Real-Time Cardiovascular Magnetic Resonance Study. Circ Cardiovasc Imaging. 2021 Aug;14(8):e011823. doi: 10.1161/CIRCIMAGING.120.011823. Epub 2021 Aug 13.
PubMed 34384226Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
PubMed 20620859Baumgartner H, Hung J, Bermejo J, Chambers JB, Evangelista A, Griffin BP, Iung B, Otto CM, Pellikka PA, Quinones M; American Society of Echocardiography; European Association of Echocardiography. Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. J Am Soc Echocardiogr. 2009 Jan;22(1):1-23; quiz 101-2. doi: 10.1016/j.echo.2008.11.029. No abstract available.
PubMed 19130998Renella P, Aboulhosn J, Lohan DG, Jonnala P, Finn JP, Satou GM, Williams RJ, Child JS. Two-dimensional and Doppler echocardiography reliably predict severe pulmonary regurgitation as quantified by cardiac magnetic resonance. J Am Soc Echocardiogr. 2010 Aug;23(8):880-6. doi: 10.1016/j.echo.2010.05.019. Epub 2010 Jul 1.
PubMed 20591618
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Operated Adult Patients With Tetralogy of Fallot and Correlation With Myocardial Strain Analysis by Cardiac Magnetic Resonance Imaging and Exercise Test
- ClinicalTrials.gov ID
- NCT07010510
- Acronym / sponsor ID
- QOL in TOF
- Conditions
- TOF
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 8 Jun 2025 (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.
Title:
Functional Assessment and Arrhythmia Prediction in Adult Patients with Repaired Tetralogy of Fallot Using a Multimodality Approach
Background:
Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect. Surgical repair has improved survival into adulthood, but long-term complications like arrhythmias and heart failure remain common. Assessing health-related quality of life (HRQOL) and cardiac function is essential.
Aim:
Assess functional status of adult patients with repaired TOF using a multimodal approach, including myocardial strain analysis via CMR.
Identify predictors of arrhythmia using strain and clinical parameters.
Methods:
Design: Prospective observational study over one year.
Population: Adults (≥18 years) with repaired TOF undergoing follow-up CMR.
Assessments:
Clinical evaluation (NYHA class)
Echocardiography (RV size, function, valve status)
Laboratory tests (BNP, NT-proBNP)
Exercise testing (METs, VO₂ max)
ECG \& 24-hour Holter monitoring (QRS duration, arrhythmias)
CMR (volumes, flow, fibrosis, strain analysis of RA, RV, LV)
Outcomes:
Primary: Functional assessment of repaired TOF patients.
Secondary: Detection of arrhythmia and need for further interventions (e.g., ICD or ablation).
Statistical Analysis:
Comparison between arrhythmic and non-arrhythmic groups.
Logistic regression for predictors of arrhythmia.
ROC analysis to determine optimal strain cut-off values.
Ethical Considerations:
Ethics committee approval and informed consent.
Data confidentiality maintained.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with TOF | – | Diagnostic Test: CMR, stress ECG, Holter, BnPThe study cohort consists of adult patients (≥18 years) with previously repaired Tetralogy of Fallot (TOF) who underwent routine clinical follow-up, including cardiac imaging, functional testing, and laboratory investigations. Patients included underwent surgical repair using either valve-sparing techniques or valved conduits and had follow-up assessments performed at least 3 months post-surgery. Data will be retrospectively collected from medical records, imaging databases, and clinical documentation. The cohort includes patients in sinus rhythm or with a documented history of ventricular arrhythmia, all of whom were referred for routine cardiovascular magnetic resonance (CMR) imaging and other functional assessments as part of standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients (age ≥18 years) with previously repaired Tetralogy of Fallot (TOF), who were referred for routine clinical follow-up at least 3 months post-surgical correction. These patients underwent standard evaluations including cardiovascular magnetic resonance (CMR), transthoracic echocardiography, ECG, Holter monitoring, NT-proBNP measurement, and exercise stress testing. Patients were either in sinus rhythm or had a documented history of ventricular arrhythmia. Individuals with other major congenital heart defects, significant valvular disease, or contraindications to CMR were excluded.
Key inclusion criteria (4 listed)
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMR, stress ECG, Holter, BnPThis study involves no experimental intervention. All data were collected retrospectively from patients with repaired Tetralogy of Fallot (TOF) who underwent standard clinical follow-up. As part of routine care, patients received comprehensive multimodal functional assessment, including: Cardiac Magnetic Resonance Imaging (CMR) with feature-tracking strain analysis Transthoracic Echocardiography Exercise stress testing (treadmill ECG using Bruce protocol) 12-lead ECG and 24-hour Holter monitoring Laboratory evaluation including NT-proBNP levels NYHA functional class assessment | Diagnostic test | Patients with TOF |
Primary outcome
NYHA Class
Time frame: 1 year
New York Heart Association (NYHA) classification 1 to 4
cardiac magnetic resonance (CMR)
Time frame: 1 years
myocardial strain parameters
Exercise capacity (METs)
Time frame: 1 years
Functional capacity 1-15
NT-proBNP levels
Time frame: 1 yeqrs
Mg/dl
1 secondary outcome
Incidence of Arrhythmia in Adults with Repaired Tetralogy of Fallot (TOF)
Time frame: At time of most recent follow-up (minimum 3 months post-surgical repair)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Background: PubMed 24076489Villafane J, Feinstein JA, Jenkins KJ, Vincent RN, Walsh EP, Dubin AM, Geva T, Towbin JA, Cohen MS, Fraser C, Dearani J, Rosenthal D, Kaufman B, Graham TP Jr; Adult Congenital and Pediatric Cardiology Section, American College of Cardiology. Hot topics in tetralogy of Fallot. J Am Coll Cardiol. 2013 Dec 10;62(23):2155-66. doi: 10.1016/j.jacc.2013.07.100. Epub 2013 Sep 27.
- Background: PubMed 1622697Carvalho JS, Shinebourne EA, Busst C, Rigby ML, Redington AN. Exercise capacity after complete repair of tetralogy of Fallot: deleterious effects of residual pulmonary regurgitation. Br Heart J. 1992 Jun;67(6):470-3. doi: 10.1136/hrt.67.6.470.
- Background: PubMed 34384226Steinmetz M, Stumpfig T, Seehase M, Schuster A, Kowallick J, Muller M, Unterberg-Buchwald C, Kutty S, Lotz J, Uecker M, Paul T. Impaired Exercise Tolerance in Repaired Tetralogy of Fallot Is Associated With Impaired Biventricular Contractile Reserve: An Exercise-Stress Real-Time Cardiovascular Magnetic Resonance Study. Circ Cardiovasc Imaging. 2021 Aug;14(8):e011823. doi: 10.1161/CIRCIMAGING.120.011823. Epub 2021 Aug 13.
- Background: PubMed 20620859Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
- Background: PubMed 19130998Baumgartner H, Hung J, Bermejo J, Chambers JB, Evangelista A, Griffin BP, Iung B, Otto CM, Pellikka PA, Quinones M; American Society of Echocardiography; European Association of Echocardiography. Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. J Am Soc Echocardiogr. 2009 Jan;22(1):1-23; quiz 101-2. doi: 10.1016/j.echo.2008.11.029. No abstract available.
- Background: PubMed 20591618Renella P, Aboulhosn J, Lohan DG, Jonnala P, Finn JP, Satou GM, Williams RJ, Child JS. Two-dimensional and Doppler echocardiography reliably predict severe pulmonary regurgitation as quantified by cardiac magnetic resonance. J Am Soc Echocardiogr. 2010 Aug;23(8):880-6. doi: 10.1016/j.echo.2010.05.019. Epub 2010 Jul 1.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of TOF, run by Assiut University.
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 6 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: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa AA Abdelhafez (01140522334, alaaabdelrahman300@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NYHA Class (time frame: 1 year). The study lists 4 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 NCT07010510, which also lists 6 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 8 Jun 2025.