Heart Failure
Conditions
Keywords
NT-proBNP, Galectin 3, GDF-15, Sacubitril -Valsartan
Brief summary
The aim of this study is to evaluate the safety and efficacy of Sacubitril -Valsartan in patients with heart failure.
Detailed 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: 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.
Interventions
DRUGSacubitril-valsartan
patients (n=30) will be given Sacubitril-valsartan 50 mg twice daily.
DRUGstandard treatment of heart failure
Control group (n=30) on standard treatment of heart failure.
Sponsors
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old for both genders. * LV ejection fraction (LVEF) ≤40%. * Heart failure patients with NYHA grade II-IV.
Exclusion criteria
1. CKD with GFR \< 20 ml/min/1.73 2. Serum potassium \< 5.5 mmol / L. 3. Pregnant or lactating women 4. Active infection. 5. Congenital heart disease. 6. Autoimmune disorders or connective tissue disorders. 7. Severe hepatic dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE incidence | 3 months | Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death. |
| Ejection fraction (EF%) | 3 months | Ejection fraction (EF%) improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NT-proBNP level (pg/ml) | 3 months | Change in NT-proBNP level |
| Galectin-3 level (pg/ml) | 3 months | Change in Galectin-3 level |
| GDF-15 level (pg/ml) | 3 months | Change in GDF-15 level |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORNouran A. Abu Shaara, Bachlore
Damanhour University
Outcome results
None listed