Efficacy and safety of a smartphone application HERB added to treatment as usual for essential hypertension: a multicenter randomized controlled phase III study

Phase 3

• Conditions: essential hypertension; hypertension; D000075222

• Registration Number: JPRN-jRCT2032190148
• Lead Sponsor: Kario Kazuomi

Brief Summary

The study was an open-label, randomized controlled trial in Japan. Patients with hypertension were randomly assigned 1:1 to the treatment group (HERB system plus standard lifestyle modification) or the control group (standard lifestyle modification only). he primary endpoint was the change from baseline in ABPM 24-hour SBP, and the treatment group showed a significant antihypertensive effect compared to the control group.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-29
• Study Completion: 2020-12-26
• Results First Posted: 2021-08-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

(1) 20 years old or older and under 65 years old
(2) Systolic blood pressure (SBP) in clinical settings: >=140 mmHg; <=179 mmHg, and/or diastolic blood pressure (DBP) in clinical settings: >=90=< and <=109 mmHg
(3) 24-hour averaged SBP of ambulatory blood pressure monitoring (ABPM) at the screening phase: >=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

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified