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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002640
Receipt No. R000003218
Scientific Title Endothelial Dysfunction Assessed by Reactive Hyperemia Peripheral Arterial Tonometry and Heart Failure with Preserved Left Ventricular Ejection Fraction
Date of disclosure of the study information 2009/10/21
Last modified on 2015/08/02

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Basic information
Public title Endothelial Dysfunction Assessed by Reactive Hyperemia Peripheral Arterial Tonometry and Heart Failure with Preserved Left Ventricular Ejection Fraction
Acronym Endothelial Dysfunction Assessed by RH-PAT and Heart Failure with Preserved LVEF
Scientific Title Endothelial Dysfunction Assessed by Reactive Hyperemia Peripheral Arterial Tonometry and Heart Failure with Preserved Left Ventricular Ejection Fraction
Scientific Title:Acronym Endothelial Dysfunction Assessed by RH-PAT and Heart Failure with Preserved LVEF
Region
Japan

Condition
Condition heart failure with normal left ventricular ejection fraction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the relationship between endothelial dysfunction and heart failure with normal left ventricular ejection fraction (HFNEF) and to investigate the prognostic involvement of endothelial dysfunction in the future cardiovascular events in patients with HFNEF.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Peripheral endothelial function
Composite endopoint of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal ischemic stroke, re-hospitalization for HF, or coronary revascularization
Key secondary outcomes NYHA classification

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with normal left ventricular ejection fraction (EF>50%) and the control patients

reactive hyperemia peripheral artery tonometry was performed
Key exclusion criteria Acute coronary syndrome
Severe valvular disease
Hypertrophic obstructive cardiomyopathy
Coronary spastic angina
Severe collagen disease
malignant disease
Hemodialysis
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisao Ogawa
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto City, JAPAN
TEL 81-96-373-5175
Email

Public contact
Name of contact person
1st name
Middle name
Last name Seigo Sugiyama
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto City, JAPAN
TEL 81-96-373-5175
Homepage URL
Email ssugiyam@kumamoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization Kumamoto University
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 熊本大学医学部附属病院(熊本県)
横浜市立大学附属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

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
2006 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 09 Month 01 Day
Date trial data considered complete
2011 Year 09 Month 01 Day
Date analysis concluded
2011 Year 09 Month 01 Day

Other
Other related information reactive hyperemia peripheral artery tonometry
echocardiography
blood sampling
ankle-brachial index(ABI)

Management information
Registered date
2009 Year 10 Month 18 Day
Last modified on
2015 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003218

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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