跳至主要内容
临床试验/NCT07197372
NCT07197372尚未招募不适用

Efficacy of Sacubitril/Valsartan Versus Captopril in Children With Dilated Cardiomyopathy Admitted to Assiut University Children Hospital: A Prospective Comparative Cohort Study

Assiut University0 个研究点目标入组 70 人开始时间: 2026年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
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

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

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

Jehan Hani Zein El-Abidin Hussein

resident doctor at pediatrics department

Assiut University

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