NCT05881720

Sacubitril/Valsartan Versus Valsartan in Heart Failure

Effect of Sacubitril/Valsartan Versus Valsartan on Left Ventricular Ejection Fraction and Biomarker in Heart Failure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Sacubitril / Valsartan Oral Tablet	Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment.
DRUG	Valsartan 80 mg	group 2 received valsartan (N=40, target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-06-18
• Completion: 2023-06-19
• First posted: 2023-05-31
• Last updated: 2023-06-27

Locations

1 site across 1 country: Egypt