Comparative Efficacy of ARNI Versus ACE Inhibitor Therapy in Egyptian Children With Dilated Cardiomyopathy

N/ANot Yet RecruitingNCT07197372

Assiut University70 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

ARNI Pediatric Dilated Cardiomyopathy ACE Inhibitor

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Change in Left Ventricular Ejection Fractio

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.

Time frame: one year

Data from ClinicalTrials.gov

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