JPRN-jRCT2032190148已完成3 期
Efficacy and safety of a smartphone application HERB added to treatment as usual for essential hypertension: a multicenter randomized controlled phase III study - HERB trial
Kario Kazuomi0 个研究点目标入组 390 人开始时间: 2019年11月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 390
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 65age old（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •(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
研究者
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