Heart drug showdown: new combo pill vs old standard in kids
NCT ID NCT07197372
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two heart failure medications—sacubitril/valsartan (a newer combo drug) and captopril (an older drug)—in 70 children aged 1 month to 18 years with dilated cardiomyopathy (an enlarged, weak heart). The goal is to see which drug better improves the heart's pumping ability over 12 months. Children must be stable on other heart therapies before joining, and those with severe kidney problems or allergies to the drugs cannot participate.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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1 month to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
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