The aim of this study is to evaluate the safety and efficacy of Sacubitril -Valsartan in patients with heart failure.
* 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: 1. MACE such as MI, stroke, HF, or death. 2. LV Echocardiography improvements of any of basic Echo parameters. 3. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
patients (n=30) will be given Sacubitril-valsartan 50 mg twice daily.
Control group (n=30) on standard treatment of heart failure.
Damanhur Medical National Institute
Damanhūr, Elbehairah, Egypt
RECRUITINGMACE incidence
Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death.
Time frame: 3 months
Ejection fraction (EF%)
Ejection fraction (EF%) improvement.
Time frame: 3 months
NT-proBNP level (pg/ml)
Change in NT-proBNP level
Time frame: 3 months
Galectin-3 level (pg/ml)
Change in Galectin-3 level
Time frame: 3 months
GDF-15 level (pg/ml)
Change in GDF-15 level
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.