Status:
NOT_YET_RECRUITING
Comparative Efficacy of ARNI Versus ACE Inhibitor Therapy in Egyptian Children With Dilated Cardiomyopathy
Lead Sponsor:
Assiut University
Conditions:
ARNI
Pediatric Dilated Cardiomyopathy
Eligibility:
All Genders
1-18 years
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 Ch...
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, sacubi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 30 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07197372
Start Date
May 30 2026
End Date
December 30 2027
Last Update
September 29 2025
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