Sacubitril-valsartan in Patients With Heart Failure.

Damanhour University

Status: Enrolling

Conditions: Heart Failure

Treatments: Drug: Sacubitril-valsartan; Drug: standard treatment of heart failure

Study type: Interventional

Funder types: Other

Identifiers

NCT07341893

sacubitril-valsartan

Details and patient eligibility

About

The aim of this study is to evaluate the safety and efficacy of Sacubitril -Valsartan in patients with heart failure.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Sacubitril-valsartan group

Active Comparator group

Description:

group (n=30) will be given Sacubitril-valsartan twice daily plus standard treatment.

Treatment:

Drug: Sacubitril-valsartan

Control group

Placebo Comparator group

Description:

Control group (n=30) on standard treatment of heart failure.

Treatment:

Drug: standard treatment of heart failure