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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011381
Receipt No. 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

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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
Email 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
Email fujisues@kumamoto-u.ac.jp

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

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013328

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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