NCT07341893

Sacubitril-valsartan in Patients With Heart Failure.

Clinical Study Evaluating Efficacy and Safety Sacubitril-valsartan in Patients With Heart Failure.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Sacubitril-valsartan	patients (n=30) will be given Sacubitril-valsartan 50 mg twice daily.
DRUG	standard treatment of heart failure	Control group (n=30) on standard treatment of heart failure.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-03-01
• Completion: 2026-03-30
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: Egypt