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

NCT ID: NCT07192341

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-27
• Study Completion Date: 2026-02-01

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).

Detailed Description

Heart failure (HF) is the end stage of various types of cardiovascular disease. The prevalence of HF continues to rise, and the rates of readmission and mortality also continue to increase significantly.

There are three types of HF, heart failure with preserved ejection fraction (HFpEF), heart failure with mid-range ejection fraction (HFmrEF), and heart failure with reduced ejection fraction (HFrEF).

Sacubitril/valsartan, the first angiotensin receptor-neprilysin inhibitor (ARNI) approved by the FDA for the treatment of HFrEF, demonstrated significant benefits in the PARADIGM-HF trial. PARADIGM-HF trial was a large multicenter, randomized clinical trial comparing sacubitril/ valsartan with enalapril in patients with LVEF < 40%. This trial showed 20% reduction in composite Cardiovascular (CV) death (including sudden cardiac death) and hospitalization for HF patients with S/V.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group S

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 Type: EXPERIMENTAL

Sacubitril/Valsartan

Intervention Type: 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 C

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

Group Type: ACTIVE_COMPARATOR

Conventional anti-heart failure therapy

Intervention Type: DRUG

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

Interventions

Sacubitril/Valsartan

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) \[Entresto, 100 mg (sacubitril 49 mg/valsartan 51 mg)\].

Intervention Type: DRUG

Conventional anti-heart failure therapy

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Ali Mohammed Hammad

Lecturer of Cardiology, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohammed A Hammad, MD

Role: CONTACT

drhammad879@gmail.com

00201015928694

Facility Contacts

Mohammed A Hammad, MD

Role: primary

drhammad879@gmail.com

00201015928694

Other Identifiers

KFSIRB200-728

Identifier Type: -

Identifier Source: org_study_id