NCT05212597

Open Label RCT for Chronic Severe AR : Entresto vs. CCB/ARB

Multicenter, Randomized, Open-label Trial to Assess the Efficacy of Sacubitril/Valsartan vs. Amlodipine/Losartan on Left Ventricular Remodeling in Patients With Chronic Severe Aortic Regurgitation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of sacubitril-valsartan compared to the combination of ARB/CCB on left ventricular remodeling in patients with chronic aortic valve regurgitation.

Detailed description

After being informed consent about the study and potential risk, all patients giving written informed consent will undergo a 1 month screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in an open-label manner in a 1:1 ratio to sacubitril-valsartan or amlodipine/losartan.

Conditions

• Aortic Valve Insufficiency

Interventions

Type	Name	Description
DRUG	Sacubitril-valsartan	50mg\~100mg twice daily
DRUG	Amlodipine-losartan	amlodipine/losartan 2.5/25mg \~ 5/100mg once daily

Timeline

• Start date: 2022-01-12
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2022-01-28
• Last updated: 2022-01-28

Locations

1 site across 1 country: South Korea