Unique ID issued by UMIN | UMIN000033311 |
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Receipt number | R000037957 |
Scientific Title | A Randomized, Open Label, Multi-center Trial of 24-week intervention with Designated Treatment Application for Essential Hypertension as compared with standard life-style modification therapy |
Date of disclosure of the study information | 2018/07/06 |
Last modified on | 2021/09/15 11:23:52 |
A Randomized, Open Label, Multi-center Trial of 24-week intervention with Designated Treatment Application for Essential Hypertension as compared with standard life-style modification therapy
A Randomized, Open Label, Multi-center Trial of 24-week intervention with Designated Treatment Application for Essential Hypertension
A Randomized, Open Label, Multi-center Trial of 24-week intervention with Designated Treatment Application for Essential Hypertension as compared with standard life-style modification therapy
A Randomized, Open Label, Multi-center Trial of 24-week intervention with Designated Treatment Application for Essential Hypertension
Japan |
Essential Hypertension
Cardiology |
Others
NO
To investigate efficacy of treatment application for essential hypertension
Safety,Efficacy
Change in mean 24-hour blood pressure from baseline at Week 24
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Device,equipment | Behavior,custom |
Intervention group:
Use the application in addition to standard therapy of hypertension with life-style modification
Control group: standard therapy of hypertension with life-style modification
20 | years-old | <= |
Not applicable |
Male and Female
Patients with mild to moderate essential hypertension using smartphones who are or are not under treatment of hypertension(drugs, etc.)
Patients with severe hypertension, a history of secondary hypertension, cardiovascular / cerebrovascular events, etc.
140
1st name | |
Middle name | |
Last name | Kazuomi Kario |
Jichi Medical University
Department of Medicine
3311-1, Yakushiji, Shimotsuke, Tochigi
0285-58-7538
kkario@jichi.ac.jp
1st name | |
Middle name | |
Last name | Taeko Kikuchi |
CureApp, Inc.
Regulatory and Clinical Affairs
4th floor, 12-5, Kodenmacho, Nihonbashi, Chuo-ku, Tokyo
03-6231-0183
t-kikuchi@cureapp.jp
CureApp, Inc.
CureApp, Inc.
Profit organization
NO
2018 | Year | 07 | Month | 06 | Day |
https://onlinelibrary.wiley.com/doi/epdf/10.1111/jch.14191
Published
https://onlinelibrary.wiley.com/doi/epdf/10.1111/jch.14191
151
At the primary endpoint at week 24, HERB intervention did not reduce the mean change in 24-hour SBP by ABPM compared to the control group (adjusted difference: -0.66 mmHg, p = 0.78).
2021 | Year | 09 | Month | 15 | Day |
2021 | Year | 01 | Month | 23 | Day |
The overall mean age was 56.8 years, 98 males and 53 females, mean weight was 71.3 kg, and BMI was 25.7. The mean abdominal circumference was 91.6 cm. Dyslipidemia was the most common complication in 67 patients (46%), diabetes in 35 (24%), cerebrovascular disease in 2, and chronic kidney disease in 11. Fifty-five percent of the patients were receiving antihypertensive medication. The mean systolic blood pressure at baseline, 24-hour ABPM, office visit, and home was 136.9 mmHg, 145.2 mmHg, and 143.9 mmHg, respectively.
The 151 participants were randomly divided into 77 in the intervention group and 74 in the control group. By 16 weeks, four patients in each group and one patient in each group asked to discontinue the study.
During the study period, forty-one AEs (43/151 [28.5%]) were occurred, and severe AEs were seen in one participant in the intervention group (unplanned admissions in different timings by hyperglycemia and cervical hernia). There was no significant difference between the groups (Intervention, 20/77 [26.0%] vs. Controls 23/74 [31.1%]). The most frequent AE was a flu-like syndrome (19/151 [12.6%]). Also, no device-related adverse events were identified through the study.
Primary endpoint
Change from baseline in the mean 24-hour systolic blood pressure by ABPM at 24 weeks of treatment
Completed
2017 | Year | 10 | Month | 18 | Day |
2017 | Year | 12 | Month | 22 | Day |
2018 | Year | 03 | Month | 01 | Day |
2019 | Year | 02 | Month | 28 | Day |
2019 | Year | 03 | Month | 20 | Day |
2018 | Year | 07 | Month | 06 | Day |
2021 | Year | 09 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037957
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