Sacubitril-valsartan in Patients With Heart Failure.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-03-30

Brief Summary

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

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Detailed Description

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* 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

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sacubitril-valsartan group

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

Group Type ACTIVE_COMPARATOR

Sacubitril-valsartan

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

standard treatment of heart failure

Intervention Type DRUG

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

Interventions

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Sacubitril-valsartan

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

Intervention Type DRUG

standard treatment of heart failure

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

Intervention Type DRUG

Other Intervention Names

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Entresto Beta blockers, ACEis

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No