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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005165
Receipt No. R000006133
Scientific Title The trial of a real-time consulting method for low salt diet by web site of a mobile phone in a patient with hypertension
Date of disclosure of the study information 2011/03/15
Last modified on 2012/09/01

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Basic information
Public title The trial of a real-time consulting method for low salt diet by web site of a mobile phone in a patient with hypertension
Acronym The trial of a real-time consulting method for low salt diet by web site of a mobile phone in a patient with hypertension (T-RMH)
Scientific Title The trial of a real-time consulting method for low salt diet by web site of a mobile phone in a patient with hypertension
Scientific Title:Acronym The trial of a real-time consulting method for low salt diet by web site of a mobile phone in a patient with hypertension (T-RMH)
Region
Japan

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

Objectives
Narrative objectives1 We evaluate efficacy of the instruction and hypotensive effect by the sodium restriction in an open-label and prospective clinical study used by 30 patients with prehypertension (SBP 130~139 mmHg and/or DBP 85~89 mmHg) or class I hypertension (SBP 140~159 mmHg and/or DBP 90~99 mmHg).
The subjects that the means of the salt intake during the observation period are 10.0g/day or more, do the self-monitoring of home blood pressure and the salt intake as the targeted value with 6 g of daily salt intakes, the sodium restriction instruction that combined the mobile phone site and face-to-face by the clinical nutritionist and the blood pressure management by the principal investigator (or the subinvestigators).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The amount and the rate of change of the daily salt intake
The amount and the rate of change of the blood pressure (hospital and home)
Key secondary outcomes A:The correlation between the daily salt intake and the blood pressure (hospital and home)

B:The search of the relations with the blood-pressure that was depressed by sodium restriction and the factors that has an influence on the sodium restriction
1.The subject background
2.The blood pressure and the heart rate
3.The daily salt intake when the subject began the sodium restriction
4.The sodium restriction instruction that combined the mobile phone site
5.The rate of taking prescription drugs (compliance)
6.The weight when the subject began the sodium restriction
7.The blood tests

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 1)The uploading contents of all meals to the mobile phone site by the subject
2)The measurement of the amount of the day salt intake by the subject
3)The home blood pressure measurement by the subject (at the time of awakening and before going to bed)
4)the sodium restriction instruction by the clinical nutritionist and the blood pressure management by the principal investigator (or the subinvestigators)
All of 1)~4) is performed for three months.
Interventions/Control_2
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)A adult with prehypertension (SBP 130~139 mmHg and/or DBP 85~89 mmHg) or class I hypertension (SBP 140~159 mmHg and/or DBP 90~99 mmHg).
2)When subjects take antihypertensive drugs, it is controlled enough, and there is not an additional plan during study period.
3)The subjects who do not take the supplements or the health foods which an effect on blood pressure suggests, or are based on a mineral such as calcium during study period.
4)20 years old or older, and under 75 years old
5)Outpatient.
6)The subjects who submit the informed consent of this study
7)The mean of the salt intake that calculated by a salt intake measuring instrument is more than 10.0g/day.
Key exclusion criteria 1)The patients with class III hypertension (SBP >= 180mmHg and/or DBP >= 110mmHg)
2)The patients with secondary hypertension
3)The patients with stroke, myocardial infarction and serious vascular disease to require hospitalization within six months
4)The patients with hepatic dysfunction (the levels of GOT (AST) and GPT (ALT) exceed 3 times of the standard value (facility criteria).)
5)The patients with renal dysfunction (>= CKD Stage III)
6)The patients with heart failure (>= NYHA III)
7)The patients with a malignant tumor or the poor-prognosis illness
8)The patients who judged the principal investigator (or the subinvestigators) to be inappropriate from a medical base
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatsugu Uchida
Organization Kanetsu hospital
Division name Internal medicine
Zip code
Address 145-1 Suneori, Tsurugashima, Saitama, 350-2213
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motoki Arakawa
Organization School of Pharmacy, Nihon University
Division name Laboratory of Pharmaceutical Regulatory Science
Zip code
Address 7-7-1 Narashinodai, Funabashi, Chiba, 274-8555
TEL
Homepage URL
Email arakawa.motoki@nihon-u.ac.jp

Sponsor
Institute Kanetsu hospital
Institute
Department

Funding Source
Organization "High-Tech Research Center" Project
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Laboratory of Pharmaceutical Regulatory Science, School of Pharmacy, Nihon University
Cyber Cross Japan, Ltd.
SRL, Ltd.
School of Medicine, Showa University
Graduate school of Medicine, Tokyo University
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 社会医療法人社団 新都市医療研究会[関越]会 関越病院 (埼玉県)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We analyzed 25 cases except two dropouts by the agreement withdrawal among 27 registration cases. A salt intake significantly decreased from 11.2g to 9.08g (P<0.001). Clinic blood pressure decreased from 137.4/87.7 to 131.7/82.1. Home blood pressure at home once in the morning significantly decreased from 136.4/85.8 to 122.2/78.2 (P<0.001). Home blood pressure at home once in the evening significantly decreased from 134.4/82.6 to 120.5/75.7 (P<0.001). Than the above-mentioned results, it was found that the sodium restriction program that we built was effective for patients with hypertension.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 01 Day
Last modified on
2012 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006133

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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