UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015651 |
|---|---|
| Receipt number | R000018197 |
| Scientific Title | OlmesaRtan Improvement endothelial functiON with hypertension study |
| Date of disclosure of the study information | 2014/11/11 |
| Last modified on | 2014/11/10 18:26:26 |
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Basic information
Public title
OlmesaRtan Improvement endothelial functiON with hypertension study
Acronym
ORION study
Scientific Title
OlmesaRtan Improvement endothelial functiON with hypertension study
Scientific Title:Acronym
ORION study
Region
| Japan |
Condition
Condition
Heart Failure with Preserved Ejection Fraction (HFpEF)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The examination of effects of olmesartan for vascular endothelial dysfunction in HFpEF patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Vascular endothelial function assessed by reactive hyperemia peripheral arterial tonometry
Key secondary outcomes
Cardiac diastolic function, various biomarkers in blood
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
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
| Medicine |
Interventions/Control_1
an angiotensin II receptor blocker (ARB); olmesartan
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
hypertensive HFpEF:
1. symptoms of HF,
2.normal or mildly reduced LV systolic function, LVEF >50% and LV end-diastolic volume index <97 ml/m2,
3. evidence of abnormal LV diastolic distensibility and stiffness.
Key exclusion criteria
1. acute coronary syndrome,
2. active infectious diseases,
3. history of malignancy,
4. end-stage renal disease (estimated glomerular filtration ratio [eGFR]:<15 ml/min/1.73 m2)
4. not meeting the diagnostic criteria for HFpEF including reduced LVEF)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichiro Yamamoto |
Organization
Kumamoto University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto city
TEL
096-373-5175
eyamamo@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiichiro Yamamoto |
Organization
Kumamoto University Graduate School of Medical Sciences
Division name
Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto city
TEL
096-373-5175
Homepage URL
eyamamo@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Kumamoto University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Kumamoto University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 11 | Month | 11 | 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
Completed
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | 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
| 2014 | Year | 11 | Month | 10 | Day |
Last modified on
| 2014 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018197
