UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011381 |
|---|---|
| Receipt number | R000013328 |
| Scientific Title | Prognostic significance of Peripheral Endothelial Dysfunction in Heart Failure with Reduced Left Ventricular Ejection Fraction |
| Date of disclosure of the study information | 2013/08/05 |
| Last modified on | 2014/07/03 19:16:58 |
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Basic information
Public title
Prognostic significance of Peripheral Endothelial Dysfunction in Heart Failure with Reduced Left Ventricular Ejection Fraction
Acronym
Endothelial Dysfunction in Heart Failure
Scientific Title
Prognostic significance of Peripheral Endothelial Dysfunction in Heart Failure with Reduced Left Ventricular Ejection Fraction
Scientific Title:Acronym
Endothelial Dysfunction in Heart Failure
Region
| Japan |
Condition
Condition
Heart failure with reduced left ventricular ejection fraction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relation between endothelial function and cardiovascular outcomes in patients with heart failure with reduced left ventricular ejection fraction.
Basic objectives2
Others
Basic objectives -Others
Assessment of prognostic factor.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome was heart failure-related events including cardiovascular death and hospitalization of heart failure.
Key secondary outcomes
The endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina pectoris, nonfatal ischemic stroke, hospitalization for heart failure decompensation, or coronary revascularization.
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 heart failure with reduced left ventricular ejection fraction (left ventricular ejection fraction <50%).
Key exclusion criteria
We excluded patients with acute coronary syndrome who required emergency coronary areteriography, defined as either acute myocardial infarction, those with unstable angina (class II or III of Braunwald's classification). We also excluded patients with advanced collagen disease, endocrine disease, active inflammatory disease, severe liver dysfunction and neoplasm, and those on 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, Chuo-ku, Kumamoto City
TEL
81-96-373-5175
ogawah@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Fujisue |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo Chuo-ku, Kumamoto City, Japan
TEL
81-96-373-5175
Homepage URL
fujisues@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
the Ministry of Education, Science, and Culture in Japan
Organization
Division
Category of Funding Organization
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 | 08 | Month | 05 | 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
| 2006 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 09 | 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
We will perform a prospective cohort study of patients with heart failure with reduced left ventricular ejection fraction, and assess the association between peripheral endothelial function using RH-PAT and cardiovascular outcome.
Management information
Registered date
| 2013 | Year | 08 | Month | 05 | Day |
Last modified on
| 2014 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013328
