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

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

Overview

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.

Interventions

• Diagnostic test CMR, stress ECG, Holter, BnP
  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 monit

Primary outcome measures

• NYHA Class [Time frame: 1 year]
• cardiac magnetic resonance (CMR) [Time frame: 1 years]
• Exercise capacity (METs) [Time frame: 1 years]
• NT-proBNP levels [Time frame: 1 yeqrs]

Secondary outcome measures (1)

• 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)]

Eligibility criteria

• Inclusion criteria:

• 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.
• Exclusion criteria:

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 24076489
• 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
• 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.120.0 PMID 34384226
• 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 Echocardiogra PMID 20620859
• 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 availabl PMID 19130998
• 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

Identifiers

NCT: NCT07010510 · QOL in TOF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗