Comparative Efficacy of ARNI Versus ACE Inhibitor Therapy in Egyptian Children With Dilated Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: ARNI, Pediatric Dilated Cardiomyopathy, ACE Inhibitor. Basic parameters: 1 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Sacubitril/Valsartan Versus Captopril in Children With Dilated Cardiomyopathy Admitted to Assiut University Children Hospital: A Prospective Comparative Cohort Study
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.
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.
Primary outcome measures
- Change in Left Ventricular Ejection Fractio [Time frame: one year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07197372 · Valsartan vs. Captopril