UMIN-CTR Clinical Trial

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

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kanetsu hospital

Institute

Department

Personal name

Organization

"High-Tech Research Center" Project

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2011

Year

03

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

03

Month

01

Day

Last modified on

2012

Year

09

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006133