essential hypertension hypertension
Conditions
Interventions
HERB is a digital therapeutic system to be adapted to the standard treatment for hypertension. The system consists of HERB Mobile: a smartphone app for patients, HERB Console: a web application for do
Sponsors
Kario Kazuomi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) 20 years old or older and under 65 years old (2) Systolic blood pressure (SBP) in clinical settings: >=140 mmHg; =90==130 mmHg (4) Patients who have not received antihypertensive medication (including those who have not received antihypertensive treatment for more than 3 months at the time of obtaining consent) (5) Patients who use a smartphone (with iOS or Android) on a daily basis (6) Patients who agree to perform ABPM at the screening phase, 12 weeks, and 24 weeks after enrollment (7) Patients with hypertension who were judged to be appropriate for the lifestyle modification treatment without antihypertensive medication by the principal investigator or a subinvestigator.
Exclusion criteria
Exclusion criteria: (1) SBP in clinical settings: >=180 mmHg; and/or DBP in clinical settings: >=110 mmHg (2) Patients who were diagnosed as secondary hypertension (3) Patients who have received (will receive) medications/combination therapy that are restricted to use by the study protocol (4) Patients who should be treated with antihypertensive medications based on their disease record, comorbidities, and risk of cerebrocardiovascular disease (5) Patients who are pregnant, suspected of being pregnant, or breastfeeding, or patients who are willing to get pregnant during the study period (6) Patients who have received renal denervation for hypertension (7) Patients who do not use a smartphone on a daily basis (8) Patients who have participated in other clinical trials within 28 days. Or patients who have participated in a clinical study related to the smartphone application "HERB" (9) Patients whose family members or partners living together are participating in this trial (10) Patients who are judged to be inappropriate to participate in this study by the principal investigator or a subinvestigator due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 24-hour SBP measured by ABPM from baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) - Amount of change in 24-hour averaged SBP measured by ABPM from baseline to week 12 (2) - Amount of change in 24-hour averaged SBP measured by ABPM from baseline to week 24 - The proportion of participants who satisfy the following targets at week 12 and week 24 - target 1: home SBP < 135 mmHg and home DBP < 85 mmHg - target 2: home SBP < 125 mmHg and home DBP < 75 mmHg - The proportion of participants whose 24-hour averaged SBP by ABPM at week 24 is lowered by more than 5 mmHg compared to week 12 - Change in 24-hour averaged DBP measured by ABPM from baseline to week 12 and week 24 - Change in daytime and nighttime averaged SBP and DBP measured by ABPM from baseline to week 12 and week 24 - Change in pulse pressure (24-hour, daytime, and nighttime) measured by ABPM from baseline to week 12 and week 24 - Change in pulse (24-hour, daytime, and nighttime) measured by ABPM from baseline to week 12 and week 24 - Change in 24-hour averaged SBP and DBP measured by ABPM from baseline to week 12 and week 24 among the Non-dipper subgroup (defined as participants with a drop of less than 10% in nighttime blood pressure during the circadian rhythm) - Ambulatory SBP and DBP variability (defined as a value obtained by dividing the standard deviation of blood pressure by the average value, for 24-hour, daytime, and nighttime) - Change in 7-day averaged (or at least 5 days excluding office visit) home SBP and DBP right after waking up and right before going to bed from baseline to week 12 and week 24 - Change in 7-day averaged (or at least 5 days excluding office visit) home pulse right after waking up and right before going to bed from baseline to week 12 and week 24 - Change in 7-day averaged (or at least 5 days excluding office visit) home SBP and DBP variability right after waking up and right before going to bed from baseline to week 12 and week 24 - Change in clinic SBP and DBP from baseline to week 12 and week 24 - Change in clinic pulse from baseline to week | — |
Contacts
Public ContactKiyose Nakagawa
CureApp, Inc.
Outcome results
None listed