Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients … (NCT03666351) | Clinical Trial Compass
CompletedPhase 4
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
South Korea128 participantsStarted 2018-10-18
Plain-language 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
Who can participate
Age range19 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female aged ≥ 19 years and \< 80 years
✓. Diagnosis of mild-moderate AS or mild-moderate AR
✓. Applicable to 2.0\~3.9 m/s of aortic jet velocity for mild-moderate AS or to 0.2\~0.6 cm of Vena contracta for mild-moderate AR
✓. Diagnosis of hypertension (SBP \> 130 mmHg if being treated or SBP \> 140 mmHg if being untreated)
✓. For females of childbearing potential; negative pregnancy test results during the screening period and prior to administration of the investigational product, and agreement on use of medically allowable contraceptive measures (condom, oral contraceptive pills, injectable or implantable contraceptives, intrauterine devices, birth control patches, etc.) during the study period
✓. Voluntary written consent to taking part in the clinical study and willingness to comply with requirements of the study
Exclusion criteria
✕. History of a cardiac valve replacement surgery (replacement surgery of mitral valve, aortic valve or tricuspid valve)
✕. Accompanied by severe mitral regurgitation
✕. Admitted to needing a surgery by the current treatment guidelines
✕. Accompanied by symptoms such as angina pectoris, exertional dyspnea, syncope, etc.
✕. \< 50% of left ventricular ejection fraction
What they're measuring
1
To evaluate changes from baseline in Left Ventricular Mass at 24M
. History of hypersensitivity reaction to active ingredients of the investigational product (Amlodipine, Losartan and Chlorthalidone), dihydropyridine derivatives, thiazide drugs and other sulfonamide derivatives or their compositions