Clinical trial NCT07010510: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: TOF
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: NYHA Class
timeFrame: 1 year
measure: cardiac magnetic resonance (CMR)
timeFrame: 1 years
measure: Exercise capacity (METs)
timeFrame: 1 years
measure: NT-proBNP levels
timeFrame: 1 yeqrs
Secondary outcomes:
measure: Incidence of Arrhythmia in Adults with Repaired Tetralogy of Fallot (TOF)
timeFrame: At time of most recent follow-up (minimum 3 months post-surgical repair)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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citation: 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.
citation: 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.