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

NCT07197372 | Not Yet Recruiting

• 1 other identifier: Valsartan vs. Captopril
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ARNI; Pediatric Dilated Cardiomyopathy; ACE Inhibitor

Keywords

ARNI; pediatric dilated cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Study Arms (1)

The population consists of Egyptian pediatric patients aged 1 month to 18 years who have been diagno

Eligible patients must demonstrate echocardiographic evidence of ventricular dilation (LVEDD z-score \>2) and systolic dysfunction (LVEF \<45%, FS \<25%). They are required to be clinically stable, on conventional background therapy, but not previously treated with sacubitril/valsartan or captopril. Children with other cardiomyopathy forms, severe renal or hepatic impairment, or significant 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.

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients must demonstrate echocardiographic evidence of ventricular dilation (LVEDD z-score \>2) and systolic dysfunction (LVEF \<45%, FS \<25%). They are required to be clinically stable, on conventional background therapy, but not previously treated with sacubitril/valsartan or captopril. Children with other cardiomyopathy forms, severe renal or hepatic impairment, or significant 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at pediatrics department

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: September 29, 2025
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share