This study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF).
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 significantly. There are three types of HF, heart failure with preserved ejection fraction (HFpEF), heart failure with mid-range ejection fraction (HFmrEF), and heart failure with reduced ejection fraction (HFrEF). Sacubitril/valsartan, the first angiotensin receptor-neprilysin inhibitor (ARNI) approved by the FDA for the treatment of HFrEF, demonstrated significant benefits in the PARADIGM-HF trial. PARADIGM-HF trial was a large multicenter, randomized clinical trial comparing sacubitril/ valsartan with enalapril in patients with LVEF \< 40%. This trial showed 20% reduction in composite Cardiovascular (CV) death (including sudden cardiac death) and hospitalization for HF patients with S/V.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
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.
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, Egypt
RECRUITINGEffective rate
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%).
Time frame: 6 months post-procedure
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