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Clinical Trials in Egypt / NCT07192341
Recruiting Not applicable

Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction

NCT07192341 · tracked via the Priya Life Science Egypt tracker
Sponsor
Kafrelsheikh University
Phase
Not applicable
Started
2025-09-27
Last updated
2025-09-30

Condition(s) studied

Sacubitril/ValsartanProsthetic Heart ValveHeart FailureReduced Ejection Fraction

Investigational drug(s) / intervention(s)

Sacubitril/Valsartan →Conventional anti-heart failure therapy

Sacubitril/Valsartan: Patients will be treated with conventional anti-heart failure therapy plus sacubitril/valsartan (oral administration of an initial dose of 24/26 mg twice daily, gradually increasing to 97/103 mg, depending on follow-up blood pressure) \[Entresto, 100 mg (sacubitril 49 mg/valsartan 51 mg)\].

Conventional anti-heart failure therapy: Patients will be treated only with conventional anti-heart failure therapy as a control group.

Study summary

This study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years old. * Both sexes. * Patients with a history of prosthetic heart valves. * Patients diagnosed with heart failure with reduced ejection fraction (HFrEF), defined as left ventricular ejection fraction (LVEF) ≤ 40% with New York Heart Association (NYHA) functional class II-IV. Exclusion Criteria: * Hemodynamic instability. * Use of a circulatory auxiliary circulation device. * Severe hepatic \[alanine aminotransferase (ALT) \>120 U/L\] and renal insufficiency \[estimated glomerular filtration rate (eGFR) \<30 mL/min\]. * Blood pressure \<100/60 mmHg. * Serum potassium \>5.3 mmol/L. * Severe pulmonary hypertension. * Malignant arrhythmia. * Malignant tumor. * Known history of hereditary or primary angioedema. * Serious adverse drug reactions or serious complications over the course of treatment.

Primary outcome measure(s)

  • Effective rate — 6 months post-procedure
    Effectiveness is defined as an New York Heart Association (NYHA) cardiac function grade improved by 1 grade or more. Effective rate= Effectiveness/total quantity\*(100%).

Trial sites (1)

FacilityCityRegionStatus
Kafrelsheikh University Kafr ash Shaykh Kafrelsheikh Recruiting

On this site

📄 Entresto (sacubitril/valsartan) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07192341 on ClinicalTrials.gov ↗ ← All trials in Egypt