Status:
RECRUITING
Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
Lead Sponsor:
Kafrelsheikh University
Conditions:
Sacubitril/Valsartan
Prosthetic Heart Valve
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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).
Detailed Description
Heart failure (HF) is the end stage of various types of cardiovascular disease. The prevalence of HF continues to rise, and the rates of readmission and mortality also continue to increase significant...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT07192341
Start Date
September 27 2025
End Date
February 1 2026
Last Update
September 30 2025
Active Locations (1)
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1
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, Egypt, 33516