Overview
The aim of this study is to evaluate the safety and efficacy of Sacubitril -Valsartan in patients with heart failure.
Description
- A 3-month, prospective interventional study, which will include 60 patients with heart failure reduced ejection fraction, patients, will be consecutively randomized into two groups, the first group (n=30) will be given Sacubitril-valsartan twice daily and the second group (n=30) on standard treatment of heart failure.
- Approval will be obtained from Research and Ethics Committee of Faculty of Pharmacy, Damanhour University. Patients will provided written informed consent and will be checked for inclusion and exclusion criteria.
- All patients will undergo analysis of inflammatory biomarkers such as: NT-proBNP, Galectin-3 and GDF-15 at beginning of the study and after 3 months of the study.
- Echocardiography study before and after the study focusing on:
Measurement of parameters such as: Left atrial diameter (LAD), basic left ventricular dimensions (EDD and ESD), Ejection fraction (EF%).
\- Follow up will be performed for assessing:
- MACE such as MI, stroke, HF, or death.
- LV Echocardiography improvements of any of basic Echo parameters.
- Assessment of New York Heart association (NYHA) class.
Outcomes: all patients will be followed up for 3 months for:
- 1ry outcomes: A.Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death. B.Heart failure hospitalization C.LV Echocardiography improvements of any of basic Echo parameters such as: Left atrial diameter (LAD), basic left ventricular dimensions (EDD and ESD), Ejection fraction (EF%).
- 2ry outcomes: Change in inflammatory markers such as: NT-proBNP, GDF-15 and Galectin-3.
Eligibility
Inclusion Criteria:
- Age ≥ 18 years old for both genders.
- LV ejection fraction (LVEF) ≤40%.
- Heart failure patients with NYHA grade II-IV.
Exclusion Criteria:
- CKD with GFR \< 20 ml/min/1.73
- Serum potassium \< 5.5 mmol / L.
- Pregnant or lactating women
- Active infection.
- Congenital heart disease.
- Autoimmune disorders or connective tissue disorders.
- Severe hepatic dysfunction.