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

Kafrelsheikh University

Status: Enrolling

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

Treatments: Drug: Conventional anti-heart failure therapy; Drug: Sacubitril/Valsartan

Study type: Interventional

Funder types: Other

Identifiers

NCT07192341

KFSIRB200-728

Details and patient eligibility

About

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

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Group S

Experimental group

Description:

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

Treatment:

Drug: Sacubitril/Valsartan

Group C

Active Comparator group

Description:

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

Treatment:

Drug: Conventional anti-heart failure therapy