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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
50mg\~100mg twice daily
amlodipine/losartan 2.5/25mg \~ 5/100mg once daily
Samsung Medical Center
Seoul, South Korea
RECRUITINGChange of left ventricular end-diastolic volume index from baseline to 12 months follow-up
Change = \[LVEDV on CMR at 12 months\]-\[LVEDV on CMR at baseline\]
Time frame: Baseline and month 12
Change of regurgitant volume of aortic valve regurgitation from baseline to 12 months follow-up.
Change = \[regurgitant volume at 12 months\]-\[regurgitant volume at baseline\]
Time frame: Baseline and month 12
Change of EROA of aortic valve regurgitation from baseline to 12 months follow-up.
Measurement of regurgitant volume of AR is derived from Doppler imaging on echocardiography. Change = \[regurgitant volume at 12 months\]-\[regurgitant volume at baseline\]
Time frame: Baseline and month 12
Change of LV end-systolic volume from baseline to 12 months follow-up.
Change = \[LVEDV at 12 months\]-\[LVEDV at baseline\]
Time frame: Baseline and month 12
Holodiastolic flow reversal in the proximal abdominal aorta and descending thoracic aorta from baseline to 12 months follow-up
presence or absence of holodiastolic flow reversal in the proximal abdominal and descending thoracic aorta on echocardiography
Time frame: Baseline and month 12
Change of NT-proBNP level from baseline to 12 months follow-up.
Change =\[NT-proBNP at 12 months\]-\[NTproBNP at baseline\]
Time frame: Baseline and month 12
Aortic valve replacement or repair operation
Any surgical event for correction of AR
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Time frame: During 12 months after enrollment