UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002640 |
|---|---|
| Receipt number | 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 06:08:10 |
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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
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
ssugiyam@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003218
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
