Efficacy of Sacubitril/Valsartan Versus Captopril in Children With Dilated Cardiomyopathy Admitted to Assiut University Children Hospital: A Prospective Comparative Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Change in Left Ventricular Ejection Fractio
研究概览
简要总结
This is a prospective, cohort study designed to evaluate the efficacy and safety of sacubitril/valsartan versus captopril in children with dilated cardiomyopathy (DCM) admitted to Assiut University Children Hospital over a one-year period.
详细描述
The trial aims to directly compare two therapies for pediatric dilated cardiomyopathy. Captopril, an ACE inhibitor, has long been the gold standard in managing pediatric heart failure. However, sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), has emerged as a potentially superior therapy with demonstrated benefits in adults. This study will assess if the newer ARNI therapy provides improved cardiac function and tolerability compared to traditional ACE inhibition in Egyptian children with DCM. Children meeting echocardiographic diagnostic criteria for systolic dysfunction will be randomized into two treatment arms. Over twelve months, detailed clinical, echocardiographic, and laboratory evaluations will track changes in left ventricular ejection fraction (LVEF), hospitalizations, safety, and quality of life. The ultimate goal is to establish evidence-based guidance for the optimal treatment of pediatric DCM in Egypt.electrolyte imbalance are excluded. The study will include a balanced distribution of both sexes, across pediatric age groups (ranging from infants to adolescents), reflective of the typical spectrum of DCM presentation in Egypt.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 month to 18 years
- •Diagnosed with dilated cardiomyopathy via echocardiography
- •LVEDD z-score > 2 (indexed to body surface area or age)
- •LVEF <45% and FS <25%
- •Clinically stable for ≥2 weeks prior to enrollment
- •Receiving optimized guideline-based heart failure therapy (excluding ACEI/ARNI prior to study)
排除标准
- •Known hypersensitivity/contraindications to ACEIs or ARNIs
- •Severe renal impairment (eGFR <30 mL/min/1.73 m²)
- •Persistent hyperkalemia (K+ >5.5 mmol/L)
- •Other cardiomyopathies (hypertrophic, restrictive) or unrelated congenital/structural heart disease
- •Severe hepatic impairment
结局指标
主要结局
Change in Left Ventricular Ejection Fractio
时间窗: one year
LVEF is measured using pediatric echocardiography at baseline and after 12 months. Improvement or decline in LVEF will be used to directly compare therapeutic efficacy.
次要结局
未报告次要终点
研究者
Jehan Hani Zein El-Abidin Hussein
resident doctor at pediatrics department
Assiut University
