UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024400
Receipt No. R000027251
Scientific Title The Study for Establishment and Generalization of Cardiovascular Prevention System with ICT; Feasibility study1; the Lifestyle Modification Program for Lower Sodium and Higher Potassium Intake
Date of disclosure of the study information 2016/11/01
Last modified on 2017/10/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The Study for Establishment and Generalization of Cardiovascular Prevention System with ICT; Feasibility study1; the Lifestyle Modification Program for Lower Sodium and Higher Potassium Intake
Acronym The Study for Establishment and Generalization of Cardiovascular Prevention System with ICT; Feasibility study1; the Lifestyle Modification Program for Lower Sodium and Higher Potassium Intake
Scientific Title The Study for Establishment and Generalization of Cardiovascular Prevention System with ICT; Feasibility study1; the Lifestyle Modification Program for Lower Sodium and Higher Potassium Intake
Scientific Title:Acronym The Study for Establishment and Generalization of Cardiovascular Prevention System with ICT; Feasibility study1; the Lifestyle Modification Program for Lower Sodium and Higher Potassium Intake
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test the feasibility and the continuity of the lifestyle modification program with Information and Communication Technology (ICT) and home medical equipment to reduce sodium intake and increase potassium intake, and to improve the data management and support system.
Basic objectives2 Others
Basic objectives -Others To establish the infrastructure to implement the lifestyle modification program to the large number of subjects
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes sodium-potassium ratio in the urine
Key secondary outcomes estimated sodium intake, estimated potassium intake, blood pressure, test of salty taste, frequency of usage of home medical equipment,etc.

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 Educational,Counseling,Training
Type of intervention
Food Behavior,custom
Interventions/Control_1 In order to to reduce salt intake and increase potassium intake, doctors individually interview participants 4 times for 4 months and send a letter once. Home medical equipment for blood pressure and sodium potassium ratio are used, and the data are collected via internet with mobile phones.

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
40 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria (1)Being possible to understand the content of the study and give the written consent
(2)Blood pressure at the last health checkup
Systolic :130-139 mmHg
Diastolic: 89 mmHg or less
(3)Renal function at the last health checkup
eGFR: 60 ml/min/1.73m2 or more
urine test: no proteinuria
Key exclusion criteria (1)Medication for hypertension, dyslipidemia, diabetes, hyperuricemia etc.
(2)Past history of angina, myocardial infarction, stroke
(3)Past history of diseases influencing electrolyte in the blood
(4)Being judged inappropriate as study participants by corresponding doctors
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Miyamoto
Organization National Cerebral and Cardiovascular Center
Division name Preventive Cardiology
Zip code
Address 5-7-1, Fujishiro-dai, Suita, Osaka
TEL 06-6833-5012
Email miyamoty@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Watanabe
Organization National Cerebral and Cardiovascular Center
Division name Preventive Cardiology
Zip code
Address 5-7-1, Fujishiro-dai, Suita, Osaka
TEL 06-6833-5012
Homepage URL
Email makotow@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center, Preventive Cardiology
Institute
Department

Funding Source
Organization National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor FUJITSU LIMITED
OMRON HEALTHCARE Co., Ltd.
Name of secondary funder(s) FUJITSU LIMITED
OMRON HEALTHCARE Co., Ltd.

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 国立循環器病研究センター

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 01 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
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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 13 Day
Last modified on
2017 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027251

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.