UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011804 |
|---|---|
| Receipt number | R000013791 |
| Scientific Title | Clinical observation study of ARB (Olmesartan) for the hypertensive patients with heart failure |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2016/09/21 18:50:31 |
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Basic information
Public title
Clinical observation study of ARB (Olmesartan) for the hypertensive patients with heart failure
Acronym
Clinical observation study of ARB (Olmesartan) for the hypertensive patients with heart failure
Scientific Title
Clinical observation study of ARB (Olmesartan) for the hypertensive patients with heart failure
Scientific Title:Acronym
Clinical observation study of ARB (Olmesartan) for the hypertensive patients with heart failure
Region
| Japan |
Condition
Condition
hypertensive patients with heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the antihypertensive therapy with ARB(Olmesartan) suppress sympathetic nervous activity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the heart autonomic nerve function after the treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hypertensive patients who meed to be administered ARB(sBP>129mmHg or dBP>84mmHg)
NT-proBNP>124pg/ml
Key exclusion criteria
The patients who have begun to take the other renin-angiotensin system inhibitors newly within one month
sBP>179mmHg or dBP>109mmHg
The patients who have atrial fibrillation or frequent premature beats
eGFR<30, the patients on hemodialysis or peritoneal dialysis, hyperkalemia
The patients who were judged to be inappropriate by the chief researcher
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Noma |
Organization
Kagawa university hospital
Division name
cardiovascular medicine
Zip code
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-898-5111
ishikawa@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shohei Ishikawa |
Organization
Kagawa university hospital
Division name
cardiovascular medicine
Zip code
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-898-5111
Homepage URL
noma@kms.ac.jp
Sponsor or person
Institute
Kagawa University faculty of medicine
cardiovascular medicine
Institute
Department
Personal name
Funding Source
Organization
Kagawa University faculty of medicine
cardiovascular medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 10 | 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
| 2013 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The examination is in progress.
Management information
Registered date
| 2013 | Year | 09 | Month | 19 | Day |
Last modified on
| 2016 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013791
