Sacubitril-valsartan in Patients With Heart Failure.

April 17, 2026 updated by: Rehab Werida, Damanhour University

Clinical Study Evaluating Efficacy and Safety 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elbehairah
      • Damanhūr, Elbehairah, Egypt, 31527
        • Damanhur Medical National Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sacubitril-valsartan group
group (n=30) will be given Sacubitril-valsartan twice daily plus standard treatment.
Drug: Sacubitril-valsartan
patients (n=30) will be given Sacubitril-valsartan 50 mg twice daily.
Other Names:
  • Entresto
Placebo Comparator: Control group
Control group (n=30) on standard treatment of heart failure.
Drug: standard treatment of heart failure
Control group (n=30) on standard treatment of heart failure.
Other Names:
  • Beta blockers, ACEis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE incidence
Time Frame: 3 months
Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death.
3 months
Ejection fraction (EF%)
Time Frame: 3 months
Ejection fraction (EF%) improvement.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NT-proBNP level (pg/ml)
Time Frame: 3 months
Change in NT-proBNP level
3 months
Galectin-3 level (pg/ml)
Time Frame: 3 months
Change in Galectin-3 level
3 months
GDF-15 level (pg/ml)
Time Frame: 3 months
Change in GDF-15 level
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Investigators

  • Principal Investigator: Nouran A. Abu Shaara, Bachlore, Damanhour University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Actual)

March 1, 2026

Study Completion (Actual)

March 30, 2026

Study Registration Dates

First Submitted

January 1, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sacubitril-valsartan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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