Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
Condition: Aortic Stenosis; Aortic Regurgitation; Hypertension; LVM; Left Ventricular Hypertrophy
MeSH terms: Hypertension; Aortic Valve Stenosis; Hypertrophy, Left Ventricular; Aortic Valve Insufficiency; Hypertrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      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
    

Detailed description: 
      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)
    

Intervention name(s): Amlodipine 5mg; Losartan; Losartan and Amlodipine; Amlodipine/Losartan/Chlorthalidone; current treatment
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): Amodipin Tab.; Osartan Tab. 50 mg; Amosartan Tab. 5/50 mg, Amosartan Tab. 5/100 mg; Amosartan Plus Tab. 5/100/12.5 mg
Intervention MeSH terms: Losartan; Amlodipine; Chlorthalidone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, multicentre, randomized, open label, evaluator-blind study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aortic Stenosis; Aortic Regurgitation; Hypertension; LVM; Left Ventricular Hypertrophy