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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07197372

Enrollment

Registered

2025-09-29

Start date

2026-05-30

Completion date

2027-12-30

Last updated

2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACE Inhibitor, ARNI, Pediatric Dilated Cardiomyopathy

Keywords

ARNI, pediatric dilated cardiomyopathy

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Left Ventricular Ejection Fractio	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.

Outcome results