To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and evaluate an influence of blood pressure regulation on improvement of left ventricular hypertrophy and its safety
1.Primary objectives \- To evaluate changes from baseline in LVM at V5 (24M) 2.Secondary objectives 1. To evaluate changes from baseline in LV global longitudinal strain at V5 (24M) 2. To evaluate changes from baseline in E/E' (E: early diastolic LV inflow velocity, E': early diastolic mitral annulus velocity) at V5 (24M) 3. To evaluate changes from baseline in LV volumes, a stroke volume index and LV ejection fraction at V5 (24M) 4. To evaluate a rate of disease progression * In case of Aortic stenosis (AS), to evaluate changes from baseline in Aortic Valve Area (AVA), Vmax, Mean Pressure Gradient (PG) and Valvulo-arterial impedance (Zva) at V5 (24M) * In case of Aortic regurgitation (AR), to evaluate changes from baseline in Vena contracta at V5 (24M) 5. To evaluate changes from baseline in blood pressure at V2(6M), V3(12M), V4(18M) and V5(24M) 6. To evaluate a cumulative incidence rate for each visit time point * Death, Cardiovascular(CV) death, Heart Failure(HF), Myocardial Infarction(MI), Hospitalization, Aortic Valve Replacement(AVR) 7. To evaluate outcomes of adverse events, physical examination, vital signs (pulse) and laboratory tests (hematological examination, blood biochemical examination, urine test and pregnancy test)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
Amlodipine 5 mg
Losartan Potassium 50 mg
Amlodipine 5 mg/Losartan Potassium 50 mg, Amlodipine 5 mg/Losartan Potassium 100 mg
Amlodipine 5 mg/Losartan Potassium 100 mg/Chlorthalidone 12.5 mg
treatment is done by maintaining the current treatment
10 Institutions Including Asan Medical Center
Seoul, South Korea
To evaluate changes from baseline in Left Ventricular Mass at 24M
To evaluate changes from baseline in Left Ventricular Mass at 24M
Time frame: 24 months
Changes from baseline in Left Ventricular global longitudinal strain at 24M
Changes from baseline in Left Ventricular global longitudinal strain at 24M
Time frame: 24 months
Changes from baseline in E/E' (E: early diastolic LV inflow velocity, E': early diastolic mitral annulus velocity) at 24M
Changes from baseline in E/E' (E: early diastolic LV inflow velocity, E': early diastolic mitral annulus velocity) at 24M
Time frame: 24 months
Changes from baseline in Left Ventricular volumes at 24M
Changes from baseline in Left Ventricular volumes at 24M
Time frame: 24 months
Rate of disease progression
* In case of Aortic Stenosis, to evaluate changes from baseline in Aortic Valve Area, tricuspid regurgitation velocity, Mean Pressure Gradient and Valvulo-arterial impedance at 24M * In case of Aortic Regurgitation, to evaluate changes from baseline in Vena contracta at 24M
Time frame: 24 months
To evaluate changes from baseline in systolic blood pressure at 6M, 12M, 18M, 24M
To evaluate changes from baseline in systolic blood pressure at 6M, 12M, 18M, 24M
Time frame: 6 months, 12 months, 18 months, 24 months
Cumulative incidence rate for each visit time point
Cumulative incidence rate for each visit time point \- Death, Cardiovascular death, Heart Failure, Myocardial Infarction, Hospitalization, Aortic Valve Replacement
Time frame: 6 months, 12 months, 18 months, 24 months
Changes from baseline in stroke volume index at 24M
Changes from baseline in stroke volume index at 24M
Time frame: 24 months
Changes from baseline in Left Ventricular ejection fraction at 24M
Changes from baseline in Left Ventricular ejection fraction at 24M
Time frame: 24 months
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