Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-05 @ 2:43 AM
Study NCT ID:
NCT03666351
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2018-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
Sponsor:
Hanmi Pharmaceutical Company Limited
Organization:
Study Overview
Official Title:
A Prospective, Multicentre, Randomized, Open Label, Evaluator-Blind, Phase IV Study to Evaluate the Effect on Improvement of Left Ventricular Hypertrophy by the Control of Blood Pressure in Hypertension Patients With Aortic Valve Disease
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
\- 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: