UMIN-CTR Clinical Trial

Basic information
Public 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
Acronym	A Randomized, Open Label, Multi-center Trial of 24-week intervention with Designated Treatment Application for Essential Hypertension
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
Scientific Title:Acronym	A Randomized, Open Label, Multi-center Trial of 24-week intervention with Designated Treatment Application for Essential Hypertension
Region	Japan

Condition
Condition	Essential Hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy of treatment application for essential hypertension
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in mean 24-hour blood pressure from baseline at Week 24
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Intervention group: Use the application in addition to standard therapy of hypertension with life-style modification
Interventions/Control_2	Control group: standard therapy of hypertension with life-style modification
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with mild to moderate essential hypertension using smartphones who are or are not under treatment of hypertension(drugs, etc.)
Key exclusion criteria	Patients with severe hypertension, a history of secondary hypertension, cardiovascular / cerebrovascular events, etc.
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuomi Kario
Organization	Jichi Medical University
Division name	Department of Medicine
Zip code
Address	3311-1, Yakushiji, Shimotsuke, Tochigi
TEL	0285-58-7538
Email	kkario@jichi.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Taeko Kikuchi
Organization	CureApp, Inc.
Division name	Regulatory and Clinical Affairs
Zip code
Address	4th floor, 12-5, Kodenmacho, Nihonbashi, Chuo-ku, Tokyo
TEL	03-6231-0183
Homepage URL
Email	t-kikuchi@cureapp.jp

Sponsor
Institute	CureApp, Inc.
Institute
Department

Funding Source
Organization	CureApp, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 06 Day

Related information
URL releasing protocol	https://onlinelibrary.wiley.com/doi/epdf/10.1111/jch.14191
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/epdf/10.1111/jch.14191
Number of participants that the trial has enrolled	151
Results	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).
Results date posted	2021 Year 09 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 01 Month 23 Day
Baseline Characteristics	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.
Participant flow	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.
Adverse events	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.
Outcome measures	Primary endpoint Change from baseline in the mean 24-hour systolic blood pressure by ABPM at 24 weeks of treatment
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 18 Day
Date of IRB	2017 Year 12 Month 22 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 20 Day

Other
Other related information

Management information
Registered date	2018 Year 07 Month 06 Day
Last modified on	2021 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037957