Quality of Life in Operated Adult Patients With Tetralogy of Fallot and Correlation With Myocardial Strain Analysis by CMR

NCT07010510 | Not Yet Recruiting

• 1 other identifier: QOL in TOF
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (4)

• NYHA Class

  New York Heart Association (NYHA) classification 1 to 4

  1 year

• cardiac magnetic resonance (CMR)

  myocardial strain parameters

  1 years

• Exercise capacity (METs)

  Functional capacity 1-15

  1 years

• NT-proBNP levels

  Mg/dl

  1 yeqrs

Secondary Outcomes (1)

• Incidence of Arrhythmia in Adults with Repaired Tetralogy of Fallot (TOF)

  At time of most recent follow-up (minimum 3 months post-surgical repair)

Study Arms (1)

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.

Diagnostic Test: CMR, stress ECG, Holter, BnP

Interventions

CMR, stress ECG, Holter, BnP DIAGNOSTIC_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

Patients with TOF

Eligibility Criteria

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

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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.

  PMID: 24076489 BACKGROUND

• Carvalho 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.

  PMID: 1622697 BACKGROUND

• Steinmetz 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.

  PMID: 34384226 BACKGROUND

• Rudski 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.

  PMID: 20620859 BACKGROUND

• Baumgartner 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.

  PMID: 19130998 BACKGROUND

• Renella 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.

  PMID: 20591618 BACKGROUND

Central Study Contacts

Alaa AA Abdelhafez

CONTACT

01140522334; alaaabdelrahman300@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 8, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share