Sacubitril-valsartan in Patients With Heart Failure.

NCT07341893 | Completed

• 1 other identifier: sacubitril-valsartan
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Keywords

NT-proBNP; Galectin 3; GDF-15; Sacubitril -Valsartan

Outcome Measures

Primary Outcomes (2)

• MACE incidence

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

  3 months

• Ejection fraction (EF%)

  Ejection fraction (EF%) improvement.

  3 months

Secondary Outcomes (3)

• NT-proBNP level (pg/ml)

  3 months

• Galectin-3 level (pg/ml)

  3 months

• GDF-15 level (pg/ml)

  3 months

Study Arms (2)

Sacubitril-valsartan group

ACTIVE COMPARATOR

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

Drug: Sacubitril-valsartan

Control group

PLACEBO COMPARATOR

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

Drug: standard treatment of heart failure

Interventions

standard treatment of heart failure DRUG

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

Also known as: Beta blockers, ACEis

Control group

Sacubitril-valsartan DRUG

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

Also known as: Entresto

Sacubitril-valsartan group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old for both genders.
• LV ejection fraction (LVEF) ≤40%.
• Heart failure patients with NYHA grade II-IV.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Damanhur Medical National Institute

Damanhūr, Elbehairah, 31527, Egypt

Location

Related Publications (2)

• Lu H, Claggett BL, Packer M, Lam CSP, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund P, McMurray JJV, Solomon SD, Vaduganathan M. Effects of Sacubitril/Valsartan on All-Cause Hospitalizations in Heart Failure: Post Hoc Analysis of the PARADIGM-HF and PARAGON-HF Randomized Clinical Trials. JAMA Cardiol. 2024 Nov 1;9(11):1047-1052. doi: 10.1001/jamacardio.2024.2566.

  PMID: 39210725 BACKGROUND

• Lee YH, Lin PL, Chiou WR, Huang JL, Lin WY, Liao CT, Chung FP, Liang HW, Hsu CY, Chang HY. Combination of ivabradine and sacubitril/valsartan in patients with heart failure and reduced ejection fraction. ESC Heart Fail. 2021 Apr;8(2):1204-1215. doi: 10.1002/ehf2.13182. Epub 2021 Jan 6.

  PMID: 33410280 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination; Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Nouran A. Abu Shaara, Bachlore

  Damanhour University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 14, 2026
• Study Start: August 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)