Skip to main content
OpenTrials
Completed

NCT Number: NCT07341893

Sacubitril-valsartan in Patients With Heart Failure.

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damanhur Medical National Institute

Damanhūr, Elbehairah, 31527, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sacubitril-valsartan

Drug

patients (n=30) will be given Sacubitril-valsartan 50 mg twice daily.

Other names: Entresto

standard treatment of heart failure

Drug

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

Other names: Beta blockers, ACEis

Primary outcomes

  1. MACE incidence

    Time frame: 3 months

    Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death.

  2. Ejection fraction (EF%)

    Time frame: 3 months

    Ejection fraction (EF%) improvement.

Secondary outcomes

  1. NT-proBNP level (pg/ml)

    Time frame: 3 months

    Change in NT-proBNP level

  2. Galectin-3 level (pg/ml)

    Time frame: 3 months

    Change in Galectin-3 level

  3. GDF-15 level (pg/ml)

    Time frame: 3 months

    Change in GDF-15 level

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.