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临床试验/NCT07010510
NCT07010510尚未招募不适用

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

Assiut University0 个研究点目标入组 100 人开始时间: 2025年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
NYHA Class

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

NYHA Class

时间窗: 1 year

New York Heart Association (NYHA) classification 1 to 4

cardiac magnetic resonance (CMR)

时间窗: 1 years

myocardial strain parameters

Exercise capacity (METs)

时间窗: 1 years

Functional capacity 1-15

NT-proBNP levels

时间窗: 1 yeqrs

Mg/dl

次要结局

  • Incidence of Arrhythmia in Adults with Repaired Tetralogy of Fallot (TOF)(At time of most recent follow-up (minimum 3 months post-surgical repair))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Abdelrahman Abdelgaber Abdelhafez

Doctor

Assiut University

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