Sacubitril/Valsartan Versus Valsartan in Heart Failure

Damanhour University

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Drug: Sacubitril / Valsartan Oral Tablet; Drug: Valsartan 80 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05881720

sacubitril/valsartan in HF

Details and patient eligibility

About

The objective of this study was to identify potential prognostic factors of sacubitril/valsartan vs Valsartan treatment response.

Full description

Study will include 80 symptomatic patients with chronic HFrEF (left ventricular ejection fraction ≤35%) and New York Heart Association (NYHA) class II/III: Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) or group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment. Analysis of biochemical parameters, cardiopulmonary exercise testing, and echocardiographic evaluation was performed at baseline and 6 months later. The primary outcome was the change in LVEF%, Lipo A, troponin I, NT-Pro BNP and neopterin levels. The secondary outcome is reporting efficacy and safety of sacubitril/valsartan vs Valsartan use and the relationship between NYHA and EF and biomarkers.

Enrollment: 80 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with HF were enrolled if aged > 35 years,
• Stable symptomatic systolic chronic HF (≥ 4 weeks), with left ventricular ejection fraction (LVEF) < 35%,
• NYHA class II-III,
• Sinus rhythm and resting HR ≥ 70 beats/min on optimised standard medical therapy.

Exclusion criteria

• Patients with acute decompensation,
• Cerebrovascular events during the previous 6 months,
• Pregnancy, breastfeeding,
• Any valve dysfunction/abnormality,
• Active myocarditis,
• Second-degree and third-degree atrioventricular block,
• Sick sinus syndrome.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Group 1 (N = 40)

Experimental group

Description:

Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment.

Treatment:

Drug: Sacubitril / Valsartan Oral Tablet

Group 2 (N = 40)

Experimental group

Description:

group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.

Treatment:

Drug: Valsartan 80 mg