ARNINCT07197372
Comparative Efficacy of ARNI Versus ACE Inhibitor Therapy in Egyptian Children With Dilated Cardiomyopathy
An observational study of ARNI and Pediatric Dilated Cardiomyopathy, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- ARNI, Pediatric Dilated Cardiomyopathy, ACE Inhibitor
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: Efficacy of Sacubitril/Valsartan Versus Captopril in Children With Dilated Cardiomyopathy Admitted to Assiut University Children Hospital: A Prospective Comparative Cohort Study
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.
Read the 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.
- Conditions
- ARNI, Pediatric Dilated Cardiomyopathy, ACE Inhibitor
- Keywords
- ARNI, pediatric dilated cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start30 May 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARNIStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jehan Hani Zein El-Abidin Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197372
- Sponsor's protocol ID
- Valsartan vs. Captopril
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sacubitril/Valsartan Versus Captopril in Children With Dilated Cardiomyopathy Admitted to Assiut University Children Hospital: A Prospective Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT07197372
- Acronym / sponsor ID
- Valsartan vs. Captopril
- Conditions
- ARNI, Pediatric Dilated Cardiomyopathy, ACE Inhibitor
- Keywords
- ARNI, pediatric dilated cardiomyopathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Left Ventricular Ejection Fractio
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ARNI and Pediatric Dilated Cardiomyopathy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fractio (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.