Digital therapeutics for essential hypertension using a smartphone application: A randomized, open‐label, multicenter pilot study
Abstract Hypertension is the most considerable but treatable risk factor for cardiovascular disease. Although physicians prescribe multiple antihypertensive drugs and promote lifestyle modifications, the real‐world blood pressure (BP) control rate remains poor. To improve BP target achievement, we d...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2021-05-01
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| Series: | The Journal of Clinical Hypertension |
| Subjects: | |
| Online Access: | https://doi.org/10.1111/jch.14191 |
| _version_ | 1827778892720504832 |
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| author | Kazuomi Kario Akihiro Nomura Ayaka Kato Noriko Harada Tomoyuki Tanigawa Ryuhei So Shin Suzuki Eisuke Hida Kohta Satake |
| author_facet | Kazuomi Kario Akihiro Nomura Ayaka Kato Noriko Harada Tomoyuki Tanigawa Ryuhei So Shin Suzuki Eisuke Hida Kohta Satake |
| author_sort | Kazuomi Kario |
| collection | DOAJ |
| description | Abstract Hypertension is the most considerable but treatable risk factor for cardiovascular disease. Although physicians prescribe multiple antihypertensive drugs and promote lifestyle modifications, the real‐world blood pressure (BP) control rate remains poor. To improve BP target achievement, we developed a novel digital therapeutic—the HERB software system —to manage hypertension. Here, we performed a randomized pilot study to assess the safety and efficacy of the HERB system for hypertension. We recruited 146 patients with essential hypertension from March 2018 to March 2019. We allocated eligible patients to the intervention group (HERB system + standard lifestyle modification) or control group (standard lifestyle modification alone). The primary outcome was the mean change from baseline to 24 weeks in 24‐hour systolic BP (SBP) measured by ambulatory blood pressure monitoring (ABPM). The baseline characteristics in each group were well balanced; the mean age was approx. 57 years, and 67% were male. In the primary end point at 24 weeks, HERB intervention did not lower the mean change of 24‐hour SBP by ABPM compared with the controls (adjusted difference: −0.66 mmHg; p = .78). In an exploratory analysis focusing on antihypertensive drug‐naïve patients aged <65, the effects of the HERB intervention were significantly greater than the control for reducing 24‐hour SBP by ABPM at 16 weeks (adjusted difference: −7.6 mmHg; p = .013; and morning home SBP at 24 weeks (adjusted difference − 6.0 mmHg; p = .012). Thus, the HERB intervention did not achieve a primary efficacy end point. However, we observed that antihypertensive drug‐naïve adult hypertensive patients aged <65 years could be a potential HERB system‐effective target for further investigations of the efficacy of the system. |
| first_indexed | 2024-03-11T14:42:31Z |
| format | Article |
| id | doaj.art-8edecaafddb44061a80abb46f8958165 |
| institution | Directory Open Access Journal |
| issn | 1524-6175 1751-7176 |
| language | English |
| last_indexed | 2024-03-11T14:42:31Z |
| publishDate | 2021-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | The Journal of Clinical Hypertension |
| spelling | doaj.art-8edecaafddb44061a80abb46f89581652023-10-30T13:30:30ZengWileyThe Journal of Clinical Hypertension1524-61751751-71762021-05-0123592393410.1111/jch.14191Digital therapeutics for essential hypertension using a smartphone application: A randomized, open‐label, multicenter pilot studyKazuomi Kario0Akihiro Nomura1Ayaka Kato2Noriko Harada3Tomoyuki Tanigawa4Ryuhei So5Shin Suzuki6Eisuke Hida7Kohta Satake8Division of Cardiovascular Medicine Department of Medicine School of Medicine Jichi Medical University Tochigi JapanCureApp Institute Karuizawa JapanCureApp Institute Karuizawa JapanDivision of Cardiovascular Medicine Department of Medicine School of Medicine Jichi Medical University Tochigi JapanCureApp Institute Karuizawa JapanCureApp Institute Karuizawa JapanCureApp, Inc. Tokyo JapanDepartment of Biostatistics and Data Science Osaka University Graduate School of Medicine Osaka JapanCureApp Institute Karuizawa JapanAbstract Hypertension is the most considerable but treatable risk factor for cardiovascular disease. Although physicians prescribe multiple antihypertensive drugs and promote lifestyle modifications, the real‐world blood pressure (BP) control rate remains poor. To improve BP target achievement, we developed a novel digital therapeutic—the HERB software system —to manage hypertension. Here, we performed a randomized pilot study to assess the safety and efficacy of the HERB system for hypertension. We recruited 146 patients with essential hypertension from March 2018 to March 2019. We allocated eligible patients to the intervention group (HERB system + standard lifestyle modification) or control group (standard lifestyle modification alone). The primary outcome was the mean change from baseline to 24 weeks in 24‐hour systolic BP (SBP) measured by ambulatory blood pressure monitoring (ABPM). The baseline characteristics in each group were well balanced; the mean age was approx. 57 years, and 67% were male. In the primary end point at 24 weeks, HERB intervention did not lower the mean change of 24‐hour SBP by ABPM compared with the controls (adjusted difference: −0.66 mmHg; p = .78). In an exploratory analysis focusing on antihypertensive drug‐naïve patients aged <65, the effects of the HERB intervention were significantly greater than the control for reducing 24‐hour SBP by ABPM at 16 weeks (adjusted difference: −7.6 mmHg; p = .013; and morning home SBP at 24 weeks (adjusted difference − 6.0 mmHg; p = .012). Thus, the HERB intervention did not achieve a primary efficacy end point. However, we observed that antihypertensive drug‐naïve adult hypertensive patients aged <65 years could be a potential HERB system‐effective target for further investigations of the efficacy of the system.https://doi.org/10.1111/jch.14191ambulatory blood pressure monitoringdigital therapeutichome blood pressure monitoringhypertensionlifestyle modificationmobile application |
| spellingShingle | Kazuomi Kario Akihiro Nomura Ayaka Kato Noriko Harada Tomoyuki Tanigawa Ryuhei So Shin Suzuki Eisuke Hida Kohta Satake Digital therapeutics for essential hypertension using a smartphone application: A randomized, open‐label, multicenter pilot study The Journal of Clinical Hypertension ambulatory blood pressure monitoring digital therapeutic home blood pressure monitoring hypertension lifestyle modification mobile application |
| title | Digital therapeutics for essential hypertension using a smartphone application: A randomized, open‐label, multicenter pilot study |
| title_full | Digital therapeutics for essential hypertension using a smartphone application: A randomized, open‐label, multicenter pilot study |
| title_fullStr | Digital therapeutics for essential hypertension using a smartphone application: A randomized, open‐label, multicenter pilot study |
| title_full_unstemmed | Digital therapeutics for essential hypertension using a smartphone application: A randomized, open‐label, multicenter pilot study |
| title_short | Digital therapeutics for essential hypertension using a smartphone application: A randomized, open‐label, multicenter pilot study |
| title_sort | digital therapeutics for essential hypertension using a smartphone application a randomized open label multicenter pilot study |
| topic | ambulatory blood pressure monitoring digital therapeutic home blood pressure monitoring hypertension lifestyle modification mobile application |
| url | https://doi.org/10.1111/jch.14191 |
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