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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name