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Detection of antihypertensive Effect using Therapy-response Evaluation with Cuffless Technology for Blood Pressure monitoring

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Essential Hypertension
Date of first enrollment	06/02/2026
Target sample size	70
Countries of recruitment
Study type	Interventional
Intervention(s)	During the study period, participants will receive one of the following medications: Indapamide 2 mg tablet: Administered orally once daily after breakfast for 5 weeks. Amlodipine besylate 5 mg tablet: Administered orally once daily after breakfast for 5 weeks.

Outcome(s)

Primary Outcome

Whether the difference in blood pressure change before and after antihypertensive treatment, as measured by the cuff-based auscultatory method and by Alysis-001 (calculated from the left forearm device), is within 5 +/- 8 mmHg (mean +/- SD) for both systolic and diastolic blood pressure.

Secondary Outcome

1. Difference in systolic and diastolic blood pressure values measured by the cuff-based auscultatory method and by Alysis-001 (left forearm device) at enrollment and after 4 weeks of treatment 2. Difference in 24-hour systolic and diastolic blood pressure changes before and after antihypertensive treatment as measured by ABPM and Alysis-001 3. Difference in 24-hour systolic and diastolic blood pressure values measured by ABPM and Alysis-001 at enrollment and after 4 weeks of treatment 4. Difference in daytime and nighttime systolic and diastolic blood pressure changes before and after antihypertensive treatment as measured by ABPM and Alysis-001 at enrollment and after 4 weeks of treatment 5. Difference in daytime and nighttime systolic and diastolic blood pressure values measured by ABPM and Alysis-001 at enrollment and after 4 weeks of treatment 6. Difference in systolic and diastolic blood pressure changes before and after antihypertensive treatment, stratified by antihypertensive drug type, as measured by the cuff-based auscultatory method and by Alysis-001 7. Comparison of 24-hour systolic and diastolic blood pressure changes before and after antihypertensive treatment, stratified by antihypertensive drug type, as measured by ABPM and Alysis-001 8. Difference in systolic and diastolic blood pressure changes before and after antihypertensive treatment, stratified by BMI and baseline blood pressure, as measured by the cuff-based auscultatory method and by Alysis-001 9. Difference in systolic and diastolic blood pressure changes before and after antihypertensive treatment, stratified by BMI and baseline blood pressure, as measured by ABPM and Alysis-001, including the change in 24-hour systolic blood pressure from baseline to 4 weeks 10. Change in systolic and diastolic blood pressure values before and after antihypertensive treatment as measured by the cuff-based auscultatory method and by Alysis-001 (calculated from the left forearm device)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 79age old
Gender	Both
Include criteria	1. Individuals aged 18 to 79 years 2. Individuals diagnosed with essential hypertension, with a systolic blood pressure of 140-159 mmHg at screening 3. Individuals with a left or right wrist circumference of 135-195 mm suitable for wearing a forearm-type cuffless blood pressure monitoring device 4. Individuals with an left upper arm circumference of 18 - 38 cm suitable for cuff-based blood pressure measurement
Exclude criteria	1. Individuals whose office systolic blood pressure at enrollment is < 140 mmHg or >= 160 mmHg 2. Individuals taking any antihypertensive medication at enrollment 3. Individuals who are unable to visit the clinic independently 4. Women who are pregnant, breastfeeding, or possibly pregnant 5. Individuals with a known hypersensitivity to dihydropyridine calcium channel blockers or thiazide-type diuretics 6. Individuals with uncontrolled diabetes mellitus 7. Individuals with hepatic dysfunction (AST or ALT >= 3 times the upper limit of normal) 8. Individuals with renal dysfunction (eGFR < 30 mL/min/1.73 m2) 9. Individuals with heart failure lassified as NYHA III-IV 10. Individuals with a current or past history of stroke (including lacunar infarction) 11. Individuals diagnosed with white-coat hypertension 12. Individuals engaged in shift work that includes night shifts 13. Individuals with wounds, burns, irregular skin surfaces, or dark pigmentation (e.g., black spots) on the wrist 14. Individuals with a vascular shunt 15. Individuals with metal allergies 16. Individuals with chronic arrhythmias 17. Individuals for whom wearing a forearm-type wearable device is difficult 18. Any other individuals deemed unsuitable for pariticipation by the attending physician