NCT03666351

Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Aortic Stenosis
• Aortic Regurgitation
• Hypertension
• LVM
• Left Ventricular Hypertrophy

Interventions

Type	Name	Description
DRUG	Amlodipine 5mg	Amlodipine 5 mg
DRUG	Losartan	Losartan Potassium 50 mg
DRUG	Losartan and Amlodipine	Amlodipine 5 mg/Losartan Potassium 50 mg, Amlodipine 5 mg/Losartan Potassium 100 mg
DRUG	Amlodipine/Losartan/Chlorthalidone	Amlodipine 5 mg/Losartan Potassium 100 mg/Chlorthalidone 12.5 mg
DRUG	current treatment	treatment is done by maintaining the current treatment

Timeline

• Start date: 2018-10-18
• Primary completion: 2022-07-25
• Completion: 2022-07-25
• First posted: 2018-09-11
• Last updated: 2022-09-15

Locations

1 site across 1 country: South Korea