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We develop a HERB system\u2014new interactive smartphone app (HERB Mobile) with web\u2010based patient management console (HERB Console)\u2014to lower blood pressure (BP) based on an algorithm that helps users to promote lifestyle modifications in conjunction with medically validated non\u2010pharmacological interventions. The app can assess the personalities, behavior characteristics, and hypertension determinants of each patient with hypertension to provide adequate guidance. To demonstrate the efficacy of the system, we designed a randomized, controlled, multicenter, open\u2010label trial \u201cHERB\u2010DH1 (HERB digital hypertension 1)\u201d to assess the efficacy of HERB system in patients with essential hypertension. The authors allocate patients to the intervention group (HERB system\u00a0+\u00a0standard lifestyle modification) or to the control group (standard lifestyle modification alone). In the intervention group, we provide the HERB Mobile for patients and the HERB Console for their primary physicians for 24\u00a0weeks. Both groups are instructed for standard lifestyle modifications based on the current recommendations in the Japanese Society of Hypertension 2019 guideline. The primary outcome is the mean change from baseline to 12\u00a0weeks in 24\u2010hour systolic BP measured by ambulatory BP monitoring. We started this study in December of 2019, and the trial results will be expected in early 2021. We believe that this trial enables us to verify the efficacy of the HERB system in patients with essential hypertension.<\/jats:p>","DOI":"10.1111\/jch.13993","type":"journal-article","created":{"date-parts":[[2020,8,28]],"date-time":"2020-08-28T05:09:00Z","timestamp":1598591340000},"page":"1713-1722","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["A multicenter clinical trial to assess the efficacy of the digital therapeutics for essential hypertension: Rationale and design of the HERB\u2010DH1 trial"],"prefix":"10.1111","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8251-4480","authenticated-orcid":false,"given":"Kazuomi","family":"Kario","sequence":"first","affiliation":[{"name":"Division of Cardiovascular Medicine Department of Medicine Jichi Medical University School of Medicine  Tochigi 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