Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
Effect of Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
Kafrelsheikh University
220 participants
Sep 27, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria10
- 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.
Interventions
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) \[Entresto, 100 mg (sacubitril 49 mg/valsartan 51 mg)\].
Patients will be treated only with conventional anti-heart failure therapy as a control group.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07192341