Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05881720
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2023-05-21
Brief Title:
SacubitrilValsartan Versus Valsartan in Heart Failure
Sponsor:
Damanhour University
Organization:
Damanhour University
Study Overview
Official Title:
Effect of SacubitrilValsartan Versus Valsartan on Left Ventricular Ejection Fraction and Biomarker in Heart Failure
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study was to identify potential prognostic factors of sacubitrilvalsartan 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 IIIII Group 1 N 40 received sacubitrilvalsartan target dose 100 mg twice daily or group 2 received valsartan target dose 80 mg twice daily in addition to recommended therapy according to physicians 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 sacubitrilvalsartan vs Valsartan use and the relationship between NYHA and EF and biomarkers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None