Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Regurgitation
- Aortic Stenosis
- Hypertension
- Left Ventricular Hypertrophy
- LVM
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A prospective, multicentre, randomized, open label, evaluator-blind studyMasking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 80 years
- Gender
- Both males and females
Description
1.Primary objectives - To evaluate changes from baseline in LVM at V5 (24M) 2.Secondary objectives To evaluate changes from baseline in LV global longitudinal strain at V5 (24M) To evaluate changes from baseline in E/E' (E: early diastolic LV inflow velocity, E': early diastolic mitral annulus veloc...
1.Primary objectives - To evaluate changes from baseline in LVM at V5 (24M) 2.Secondary objectives To evaluate changes from baseline in LV global longitudinal strain at V5 (24M) To evaluate changes from baseline in E/E' (E: early diastolic LV inflow velocity, E': early diastolic mitral annulus velocity) at V5 (24M) To evaluate changes from baseline in LV volumes, a stroke volume index and LV ejection fraction at V5 (24M) 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) To evaluate changes from baseline in blood pressure at V2(6M), V3(12M), V4(18M) and V5(24M) 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) To evaluate outcomes of adverse events, physical examination, vital signs (pulse) and laboratory tests (hematological examination, blood biochemical examination, urine test and pregnancy test)
Tracking Information
- NCT #
- NCT03666351
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Duk-Hyun Kang 10 institutions including Asan Medical Center