Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction

NCT07192341 | Recruiting

• 1 other identifier: KFSIRB200-728
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF).

Conditions

Sacubitril/Valsartan; Prosthetic Heart Valve; Heart Failure; Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Effective rate

  Effectiveness is defined as an New York Heart Association (NYHA) cardiac function grade improved by 1 grade or more. Effective rate= Effectiveness/total quantity\*(100%).

  6 months post-procedure

Study Arms (2)

Group S

EXPERIMENTAL

Patients will be treated with conventional anti-heart failure therapy plus sacubitril/valsartan (oral administration of an initial dose of 24/26 mg twice daily, gradually increasing to 97/103 mg, depending on follow-up blood pressure) \[Entresto, 100 mg (sacubitril 49 mg/valsartan 51 mg)\].

Drug: Sacubitril/Valsartan

Group C

ACTIVE COMPARATOR

Patients will be treated only with conventional anti-heart failure therapy as a control group.

Drug: Conventional anti-heart failure therapy

Interventions

Sacubitril/Valsartan DRUG

Patients will be treated with conventional anti-heart failure therapy plus sacubitril/valsartan (oral administration of an initial dose of 24/26 mg twice daily, gradually increasing to 97/103 mg, depending on follow-up blood pressure) \[Entresto, 100 mg (sacubitril 49 mg/valsartan 51 mg)\].

Group S

Conventional anti-heart failure therapy DRUG

Patients will be treated only with conventional anti-heart failure therapy as a control group.

Group C

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old.
• Both sexes.
• Patients with a history of prosthetic heart valves.
• Patients diagnosed with heart failure with reduced ejection fraction (HFrEF), defined as left ventricular ejection fraction (LVEF) ≤ 40% with New York Heart Association (NYHA) functional class II-IV.

You may not qualify if:

• Hemodynamic instability.
• Use of a circulatory auxiliary circulation device.
• Severe hepatic \[alanine aminotransferase (ALT) \>120 U/L\] and renal insufficiency \[estimated glomerular filtration rate (eGFR) \<30 mL/min\].
• Blood pressure \<100/60 mmHg.
• Serum potassium \>5.3 mmol/L.
• Severe pulmonary hypertension.
• Malignant arrhythmia.
• Malignant tumor.
• Known history of hereditary or primary angioedema.
• Serious adverse drug reactions or serious complications over the course of treatment.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Mohammed A Hammad, MD

CONTACT

00201015928694; drhammad879@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Cardiology, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: September 27, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available upon a reasonable request from the corresponding author.
• Access Criteria: After the end of study for one year.

Locations

EG (1)